BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    DIAL MEDICAL SUPPLY

    MDR report key: 86036 · Received April 17, 1997

    Report

    Report Number
    1051129-1997-00011
    Event Type
    Malfunction
    Date Received
    April 17, 1997
    Date of Event
    March 18, 1997
    Report Date
    April 17, 1997
    Manufacturer
    GAMBRO HEALTHCARE
    Product Code
    KPO
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CO OF DELAND FLORIDA SUBMITTED TO THE CORP. LABS GROUP, A SAMPLE FOR EVALUATION OF DEBRIS FROM AN ACID CONCENTRATE PRODUCT AC-2414 LOT 703106D. THIS WAS IN THE RESPONSE TO CUSTOMER COMPLAINT 97008. A 1.0 MICRON "GAF" BAG FILTER WAS USED BY CO TO FILTER THE REMAINING OF THE SUSPECT DRUM OF ACID CONCENTRATE. THE FILTER WAS SUBMITTED TO CORPORATE LABS WHERE A THROUGH RINSING OF THE FILTER WAS MICROSCOPICALLY OBSERVED AT ALL FIVE LAYERS. A MINIMAL AMOUNT OF DEBRIS WAS OBSERVED IN THE FORM OF BLACK AND REDDISH BROWN DEBRIS. THE BLACK DEBRIS IS CONSISTENT WITH PARTICULATES OBSERVED BY THE COMPLAINANT AND APPEAR TO BE FROM AN O-RING, USED IN THE MFG PROCESS. CO SUBMITTED A SAMPLE OF THE CONCENTRATE FOR LEAD ANALYSIS. BECAUSE WE DID NOT KNOWN WHAT THE REPORTED PARTICULATES WERE AND ON A RECOMMENDATION OF AN FDA INVESTIGATOR, THE SAMPLE WAS SUBMITTED FOR LEAD ANALYSIS. TEST RESULTS SHOW THE SAMPLE CONTAINED 2.6PPB OF LEAD. AAMI DOES NOT HAVE A SPECIFICATION FOR LEAD IN THE CONCENTRATE. AAMI LIMIT FOR LEAD IN WATER USED TO PREPARE DIALYSATE IS 5 PPB.

    Description of Event or Problem · 1

    ON 3/18/97, TECHNICAL SUPERVISOR, REPORTED A DRUM OF AC-2414 LOT 703106D CONTAINED SOME FOREIGN OBJECTS. TECHNICAL SUPERVISOR REPORTED HIS PRACTICE IS TO HAND-PUMP THE PRODUCT OUT OF THE DRUM INTO CLEAN CONTAINERS, WHICH ARE BROUGHT TO THE DIALYSIS MACHINE. AFTER DIALYSIS WAS COMPLETED IN THE PT, SUPERVISOR OBSERVED SOME FOREIGN OBJECTS IN THE CONTAINER. TECHNICAL SUPERVISOR REPORTED HE FILTERED THE REMAINING CONCENTRATE IN THE CONTAINER, CAPTURING THE FOREIGN OBJECTS. TECHNICAL SUPERVISOR ASKED TO FORWARD THE FOREIGN CONCENTRATE; ONE DIRECTLY OUT OF THE DRUM AND ONE TAKEN THROUGH THE HAND-PUMP.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 DIAL MEDICAL SUPPLY HEMODIALYSIS CONCENTRATE KPO GAMBRO HEALTHCARE * 703106D

    Patients

    Seq Age Sex Outcome Treatment
    1 *