leadsag
Joined: 31 Oct 2002
Posts: 263
Posted: Fri Oct 24, 2003 4:37 am Post subject: Another reason for non-reuse
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From US FDA Adverse Events reports. <
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>MAUDE Database<
>BRAND NAME OPTIFLUX 200A DIALYZER FINISHED ASSY. <
>BASELINE BRAND NAME OPTIFLUX 200A DIALYZER FINISHED ASSY. <
>BASELINE GENERIC NAME HEMODIALYZER REPROCESSING DEVICE <
>BASELINE CATALOGUE NUMBER 0500320A <
>OTHER BASELINE ID NUMBER 0500320A <
>MANUFACTURER (Section F) OGEN MFG <
>475 WEST 13TH ST <
>OGDEN UT 84404 <
> <
>MANUFACTURER (Section D) OGEN MFG <
>475 WEST 13TH ST <
>OGDEN UT 84404 <
> <
>MANUFACTURER CONTACT ELIZABETH POLHEMUS <
>TWO LEDGEMONT CENTER <
>LEXINGTON , MA 02173 <
>(781) 402 -9075 <
> <
>DEVICE EVENT KEY 462243 <
>MDR REPORT KEY 473420 <
>EVENT KEY 448731 <
>REPORT NUMBER 1713747-2003-00086 <
>DEVICE SEQUENCE NUMBER 1 <
>PRODUCT CODE FJI <
>REPORT SOURCE MANUFACTURER <
>SOURCE TYPE USER FACILITY <
>REMEDIAL ACTION OTHER <
>EVENT TYPE NO ANSWER PROVIDED <
>TYPE OF REPORT INITIAL <
>REPORT DATE 07/02/2003 <
>1 DEVICE WAS INVOLVED IN THE EVENT <
>1 PATIENT WAS INVOLVED IN THE EVENT <
>DATE FDA RECEIVED 07/02/2003 <
>IS THIS AN ADVERSE EVENT REPORT? NO <
>DEVICE CATALOGUE NUMBER 0500320A <
>DEVICE LOT NUMBER 2NU228 <
>OTHER DEVICE ID NUMBER 0500320A <
>WAS DEVICE EVALUATED BY MANUFACTURER? NO <
>IS THE DEVICE SINGLE USE? NO <
>TYPE OF DEVICE USAGE REUSE <
>ADVERSE EVENT OR PRODUCT PROBLEM DESCRIPTION <
>REPORT DATE: 07/02/2003 MDR TEXT KEY: 1641847 Patient Sequence Number: 1 <
>UNIT ADMITTED TWO PTS TO THE HOSP FOLLOWING CHILLS AND FEVER DEVELOPED WHILE ON DIALYSIS. TWO ORGANISMS WERE CULTURED FROM BOTH PT'S BLOOD, ONE A YEAST AND THE OTHER A GRAM NEGATIVE ORGANISM. DURING AN ON-GOING INVESTIGATION AT THE UNIT THE YEAST WAS CULTURED FROM BENEATH THE 'O' RING IN THE HEADER OF THEIR DIALYZER. THE DIALYZER HAD BEEN REUSED AN UNK NUMBER OF TIMES WITH RENALIN ON A RENATRON REPROCESSING MACHINE. PT HAD A POSITIVE BLOOD CULTURE FOR CANDIDA PARAPSILOSIS AND BURKHOLDERIA PICKETTII. PT'S BLOOD CULTURES ALSO POSITIVE FOR STENOTROPHOMANS. CULTURE OF THE DIALYZER DONE IN THE FACILITY WAS POSITIVE FOR YEAST (UNDER THE "O" RING AND IN THE "O" RING GROOVE. THE DIALYZER RESUED 40 TIMES AND PRE-CLEANED WITH A REVERSE UF FLUSH. NO ACTUAL OR COMPARISON SAMPLE AVAILABLE.<
> <
> <
>MANUFACTURER DEVICE EVALUATION SUMMARY <
>REPORT DATE: 07/02/2003 MDR TEXT KEY: 1641848 <
>NOT RETURNED TO MFR.<
> <
> <
>ADDITIONAL MANUFACTURER NARRATIVE <
>REPORT DATE: 07/02/2003 MDR TEXT KEY: 1641849 <
>SAMPLE NOT AVAILABLE FOR EVAL. THE FACILITY REPORTS THE DIALYZER HAD BEEN REUSED 40 TIMES. THIS INFO CONFIRMED THAT THE COMPLAINT ISSUE IS NOT AN OUT-OF-BOX PRODUCT FAILURE RELATED TO THE MFG PROCESS. A DEFINITIVE CONCLUSION CANNOT BE REACHED WITHOUT EXAMINATION OF THE COMPLAINT SAMPLE. CO WILL CONTINUE TO MONITOR FOR TRENDS.<
> <
> <
>PATIENT TREATMENT DATA <
>Date Received: 07/02/2003 Patient Sequence Number: 1 <
># Treatment Treatment Date <
>1,RENALIN DISINFECTANT,, <
>2,RENATRON REPROCESSING MACHINE,, <
>3,REVERSE UF PRE-FLUSH., <
> <
>
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Lin
Joined: 28 Oct 2002
Posts: 337
Posted: Fri Oct 24, 2003 9:52 am Post subject: Unit closed
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I'm appalled! I keep hearing people who are in favor of reuse saying that "if it's done right", but this report makes me wonder if perhaps even where it's "done right" nasty little critters scurry around anyway, and no one even thinks to look for a problem. Ewww! I haven't had my dinner yet, and that report just ruined my appetite. <
>Thanks! Lin.
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Another one
Joined: 24 Oct 2003
Posts: 1
Posted: Fri Oct 24, 2003 10:03 am Post subject: Eat first lin
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ADVERSE EVENT OR PRODUCT PROBLEM DESCRIPTION <
>REPORT DATE: 05/30/2003 MDR TEXT KEY: 1610285 Patient Sequence Number: 1 <
>4 PATIENTS EXPERIENCED REACTIONS ON INITIATION OF DIALYSIS. SYMPTOMS INCLUDED NUMBNESS OF THE LIPS, SWELLING OF THE JAW, HYPOTENSION, SHORTNESS OF BREATH, DIARRHEA AND BACK PAIN. 1 PATIENT WAS REMOVED FROM DIALYSIS AND SENT TO THE HOSPITAL. 3 REMAINING PATIENTS WERE TAKEN OFF OF DIALYSIS AND SENT HOME. PATIENT SENT TO THE HOSPITAL ER WAS TREATED AND RELEASED. THIS PATIENT DID NOT REQUIRE HOSPITALIZATION. ALL 4 PATIENTS DOING WELL WITH NO ILL EFFECTS REPORTED.<
> <
> <
>ADDITIONAL MANUFACTURER NARRATIVE <
>REPORT DATE: 05/30/2003 MDR TEXT KEY: 1610288 <
>EVAL WAS INTERVIEWING THE INITIAL REPORTER A NURSE AND THE ADMINISTRATOR. DOCTOR REPORTED 4 PATIENTS WITH REACTIONS ON INITIATION OF DIALYSIS. SYMPTOMS INCLUDED NUMBNESS OF THE LIPS, SWELLING OF THE JAW, HYPOTENSION, SHORTNESS OF BREATH, DIARRHEA AND BACK PAIN. ALL PATIENTS WERE DIALYZING ON POLYFLUX DIALYZERS (21R) THAT HAD BEEN REPROCESSED WITH RENALIN/RENATRON. ALL PATIENTS WERE DIALYZING ON GAMBRO PHOENIX DELIVERY AND SENT TO THE HOSPITAL, THE OTHER 3 WERE TAKEN OFF OF DIALYSIS AND SENT HOME. THE PATIENT SENT TO THE HOSPITAL HAD BREATHING PROBLEMS AND WAS GIVEN OXYGEN AND BENADRYL BY THE NURSE PRIOR TO BEING SENT TO THE ER. ALL PATIENTS REPORTED TO BE DOING WELL. IN REVIEWING THE FACILITY'S DIALYZER RINSE PROCEDURE WITH THE DOCTOR, IT WAS NOTED TO HAVE SEVERAL DEVIATIONS FROM THE MINNTECH RECOMMENDED RINSE PROCEDURE. FOLLOW-UP CALL TO ADMINISTRATOR WHO STATED THE PATIENT SENT TO THE ER WAS NEVER ADMITTED, BUT WAS TREATED AND SENT HOME. ALL PATIENTS ARE STILL DOING FINE AND WERE BACK ON REUSE AGAIN WITH NO PROBLEMS REPORTED. NONE OF THE PATIENTS HAVE REPORTED ANY ILL EFFECTS AS A RESULT OF THE INCIDENT. MANUFACTURER SUSPECTS USER ERROR CAUSED THE INCIDENT.<
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two others
Joined: 24 Oct 2003
Posts: 1
Posted: Fri Oct 24, 2003 10:26 am Post subject: all within the last year
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ADVERSE EVENT OR PRODUCT PROBLEM DESCRIPTION <
>REPORT DATE: 03/20/2003 MDR TEXT KEY: 1563005 Patient Sequence Number: 1 <
>UPON INITIATION OF TREATMENT, THE PT COMPLAINED OF FEELING HOT, HAVING A TINGLING SENSATION AND NUMBNESS IN THEIR MOUTH. (NURSE NOTED BLOOD COMING OUT OF THE DIALYZER WAS BLACK.) TREATMENT WAS STOPPED IMMEDIATELY AND THE SET UP WAS CHANGED OUT. PHYSICIAN WAS CALLED PER THEIR PROTOCOL. PT WAS PLACED ON OXYGEN VIA NOSE CANNULA AT 2L/MIN. TREATMENT WAS REINITIATED ON A "DRY PACK" DIALYZER AND PT COMPLETED TREATMENT WITHOUT ANY COMPLICATIONS. NO HOSPITALIZATION WAS REQUIRED. PT DOING FINE, WITH NO FURTHER PROBLEMS REPORTED.<
> <
> <
>ADDITIONAL MANUFACTURER NARRATIVE <
>REPORT DATE: 03/20/2003 MDR TEXT KEY: 1563008 <
>H11: NURSE STATED ALMOST 1000CC OF SALINE WAS USED TO RINSE THE DIALYZER, ALL HOSES WERE CONNECTED AND DIALYSATE FLOWS ESTABLISHED, ALL HOSES WERE CONNECTED AND DIALYSATE FLOWS ESTABLISHED DURING RINSING. THEY STATED THERE COULD HAVE BEEN A LITTLE LAG TIME BETWEEN THE TIME THE RESIDUAL TESTING WAS DONE AND THE PT WAS CONNECTED FOR TREATMENT. NURSE REPORTS PT IS DOING FINE NOW, BUT IS NO LONGER ON REUSE BECAUSE PT RECEIVES NO HEPARIN DURING TREATMENT (HAS RETINAL BLEEDING) AND FACILITY HAD INTENTED TO TAKE PT OFF REUSE REGARDLESS. NO OTHER PT REACTIONS WERE REPORTED THAT DAY. MANUFACTURER SUSPECTS USER ERROR CAUSED INCIDENT.<
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>ADVERSE EVENT OR PRODUCT PROBLEM DESCRIPTION <
>REPORT DATE: 03/20/2003 MDR TEXT KEY: 1563014 Patient Sequence Number: 1 <
>2 MINUTES INTO TREATMENT, PT REPORTED HAVING A TINGLING SENSATION AND NUMBNESS IN THE MOUTH AND FELT VERY "STRANGE". TREATMENT WAS STOPPED AND THE SET UP WAS CHANGED OUT. TREATMENT WAS REINITIATED ON A "DRY PACK" DIALYZER AND PT COMPLETED TREATMENT WITHOUT ANY COMPLICATIONS. NO HOSITALIZATION WAS REQUIRED. PT DOING FINE WITH NO FURTHER PROBLEMS REPORTED.<
> <
> <
>ADDITIONAL
MANUFACTURER NARRATIVE <
>REPORT DATE: 03/20/2003 MDR TEXT KEY: 1563017 <
>NURSE STATED ALL HOSES WERE ATTACHED AND THE DIALYSATE FLOW ESTABLISHED DURING RINSING. A RENALIN RESIDUAL TEST WAS DONE AND THE RESULTS WERE NEGATIVE. NURSE REPORTS PT IS DOING FINE AND HAS BEEN STARTED BACK ON REUSE AND HAS HAD NO PROBLEMS. NO OTHER PT REACTIONS WERE REPORTED THAT DAY. MANUFACTURER SUSPECTS USER ERROR.<
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patient
Joined: 29 Oct 2002
Posts: 137
Posted: Fri Oct 24, 2003 11:07 am Post subject: 40x reuse??????
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can a dialyzer be reused forty times and not self destruct and fall into a million pieces?
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Curious
Joined: 02 Feb 2003
Posts: 39
Posted: Fri Oct 24, 2003 12:33 pm Post subject: Can use as many times as they want
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You as a patient can refuse reuse. It is a choice. Why use something 40 times with chemicals, when you can have a new dializer with NO CHEMICALs each time.<
>That is a no
ainer. Say NO!
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Curious
Joined: 02 Feb 2003
Posts: 39
Posted: Fri Oct 24, 2003 12:34 pm Post subject: Can use as many times as they want
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You as a patient can refuse reuse. It is a choice. Why use something 40 times with chemicals, when you can have a new dializer with NO CHEMICALs each time.<
>That is a no
ainer. Say NO!
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hemorn
Joined: 04 Nov 2003
Posts: 1
Posted: Tue Nov 04, 2003 4:00 am Post subject: Reuse vs Dry Pack
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Original Article <
><
>Reduction of circulating microemboli in the subclavian vein of patients undergoing haemodialysis using pre-filled instead of dry dialysers <
>Dirk W. Droste1,2, Torsten Beyna1, Bernhard Frye3, Volker Schulte1, E. Bernd Ringelstein1 and Roland M. Schaefer4 <
>1Department of Neurology, University of M?nster, Germany, 2Department of Neurology, Centre Hospitalier de Luxembourg, Luxembourg, 3Dialysezentrum Praxisklinik Haus Sentmaring, M?nster and 4Department of Medicine D, University of M?nster, Germany <
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>Correspondence and offprint requests to: PD Dr Dirk W. Droste, Service de Neurologie, Centre Hospitalier de Luxembourg, 4 rue Barbl?, L-1210 Luxembourg, Luxembourg. Email: droste2@uni-muenster.de <
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>Background. Chronic microembolization that can be demonstrated by pulsed Doppler ultrasound may give rise to pulmonary side-effects during haemodialysis by direct vessel obstruction, increased complement activation or platelet aggregation. The objective of the present investigation was to study whether the use of pre-filled instead of dry dialysers would help to minimize the number of microemboli. <
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>Methods. The study cohort consisted of 23 patients undergoing maintenance haemodialysis. Using a 2 MHz pulsed ultrasound device, the subclavian vein downstream to the dialysis fistula was investigated for 10 min during the dialysis session. The ultrasound examination was performed twice during two successive dialysis sessions, using a pre-filled or a dry dialyser in randomized order. <
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>Results. In all patients investigated, numerous microembolic signals (MES) could be observed in the subclavian vein. Treatment with pre-filled dialysers was associated with significantly less MES (82 ? 94) as compared with dry dialysers (268 ? 296; P = 0.002). <
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>Conclusions. In comparison to dry dialysers, the use of pre-filled dialysers leads to a significant reduction in microembolization, which may prevent repeated damage to the pulmonary vasculature and, thus, cause less pulmonary damage. <
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>Key words: dialysis; microemboli; ultrasonography<
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>HOME HELP FEEDBACK SUBSCRIPTIONS ARCHIVE SEARCH TABLE OF CONTENTS <
>Copyright ? 2003 by the European Renal Association - European Dialysis and Transplant Association.
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Lin
Joined: 28 Oct 2002
Posts: 337
Posted: Thu Nov 06, 2003 12:55 pm Post subject: Just
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run the proper amount of saline through the dialyzer prior to initiation of tx.. No shortcuts!!! Lin.
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patient
Joined: 29 Oct 2002
Posts: 137
Posted: Thu Nov 06, 2003 11:17 pm Post subject: pre-filled and dry
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I can't really tell the difference in well being and I have been treated with prefilled and dry pack large dialyzers.
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leadsag
Joined: 31 Oct 2002
Posts: 263
Posted: Fri Nov 07, 2003 1:14 am Post subject: a new one
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A friend of mine met with his Nephrologist about switching to single use was told 'that the filter I will be using leaks some and is not as good as a reuse.'<
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>Why would they use a filter that leaks? Why would they be allowed to not use a filter that is not as good? Is that not boarding on medical malpractice?
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Lin
Joined: 28 Oct 2002
Posts: 337
Posted: Fri Nov 07, 2003 1:38 am Post subject: Something is rotten
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and stinks! In the unit I go to they do non reuse and dry packs. If someone drops one they don't take any chances, and it's thrown away. Of course the DON is not happy about it as it's money tossed into the trash. Lin.
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leadsag
Joined: 31 Oct 2002
Posts: 263
Posted: Fri Nov 07, 2003 4:58 am Post subject: drops
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If someone drops one here - they quickly look at it for cracks and procede to put it on the machine. Never mind that the internal fibers might be all
oken - as long as it doesn't leak so they have to clean up a mess it is good to go as far as they are concerned
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patient
Joined: 29 Oct 2002
Posts: 137
Posted: Fri Nov 07, 2003 5:54 am Post subject: pre-filled with sterile solution by manufacturer not reuse
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sorry, i didn't explain in earlier post that i have never been on reuse. this dialyzer is made by Asahi and comes in package pre-filled with some sort of sterilized solution. i can't tell the difference between the "pre-filled with sterile solution by the manufacturer and a dry pack dialyzer both being non-reuse".
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FRN
Joined: 24 Feb 2003
Posts: 25
Posted: Fri Nov 07, 2003 6:08 am Post subject: Leaks
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If there is any leaking or
oken fibers, then blood would leak out and the blood leak alarms would go off. Most machines are very sensative with this. In fact I get blood leak alarms when setting up a dry dializer as the air registers as blood. So I don't
think that agument holds any water so to speak!
