BEUDAMED
    FDA Adverse Event Other Summary report: N

    DIACIDE DIALYZER DISINFECTING SOLUTION

    MDR report key: 136923 · Received December 5, 1997

    Report

    Report Number
    1222243-1997-00003
    Event Type
    Other
    Date Received
    December 5, 1997
    Date of Event
    November 21, 1997
    Report Date
    December 5, 1997
    Manufacturer
    GULFSTREAM MEDICAL, INC.
    Product Code
    LIF
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    FREQUENCY OF OCCURRENCE: THESE INCIDENTS AS DESCRIBED ABOVE DO NOT OCCUR WITH ANY ANTICIPATED FREQUENCY, BUT WILL OCCUR WHENEVER IMPROPER PROCEDURES ARE EMPLOYED BY THE END-USER. PT REACTIONS OCCUR NOT ONLY WITH GLUTARALDEHYDE (DIACIDE), BUT ALSO WITH FORMALDEHYDE AND PERACETIC ACID DISINFECTANTS WHICH ARE THE OTHER TOW GERMICIDES USED IN DIALYSIS. HISTORICAL DATA HAS SHOWN THAT THIS SYNDROME WOULD OCCUR TWO OR THREE TIMES PER YEAR WITH DIACIDE, AND THE RESIDUAL TEST INTERPRETATION USING NEPHRETECT, TO OUR KNOWLEDGE, HAS ALWAYS BEEN ACCEPTABLE. SEVERITY OF OCCURRENCE: THE SEVERITY OF THE PT'S REACTION IN THE CASES CITED IN THIS REPORT WERE EXTREMELY MILD.

    Description of Event or Problem · 1

    CLINIC HAS BEEN USING DIACIDE DISINFECTANT FOR USE IN FRESENIUS F80 DIALYZERS, WITH A COBE C3 DELIVERLY MACHINE. CUSTOMER HAS USED THIS CONFIGURATION FOR SEVERAL YEARS WITH NO UNTOWARD EVENTS. ON 11/21/1997 SEVERAL PTS EXPERIENCED MINOR ALLERGIC REACTION AFTER BEING PLACED ON DIALYSIS BOTH AT THE ONSET OF DIALYSIS AND IN SOME CASES A FEW MINUTES INTO DIALYSIS. IN ALL CASES, DIALYSIS WAS DISCONTINUED AND RESTARTED USING A NEW DIALYZER. REACTIONS CONTINUED TO OCCUR FOR THE NEXT TWO OR THREE DAYS AND REUSE OF DIALYZERS WAS SUSPENDED UNTIL THE PROBLEM COULD BE INVESTIGATED AND THE CAUSE OF PT REACTION WAS DETERMINED. FOLLOW UP TELEPHONE CALLS WERE MADE TO THE CLINIC ON 12/08/1997, 12/11/1997, 12/16/1997 AND 12/19/1997, AND EACH CASE NO FURTHER INCIDENTS HAD OCCURRED. THE CUSTOMER INDICATED THAT THEY HAD MADE CHANGES IN THEIR RINSING PROCEDURE AND THAT THE PROBABLE CAUSE OF THE ORIGINAL INCIDENTS WERE DUE TO IMPROPER PROCEDURES IN THEIR RINSING PROTOCOL. END OF REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIACIDE DIALYZER DISINFECTING SOLUTION DISINFECTANT LIF GULFSTREAM MEDICAL, INC. NA UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other FRESENIUS DIALYZERS F80.