BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRISMA SET

    MDR report key: 788695 · Received November 20, 2006

    Report

    Report Number
    8010182-2006-00014
    Event Type
    Malfunction
    Date Received
    November 20, 2006
    Date of Event
    October 26, 2006
    Report Date
    November 17, 2006
    Manufacturer
    GAMBRO INDUSTRIES
    Product Code
    FJK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    INVALID DATA

    Narratives

    Additional Manufacturer Narrative · 1

    THE REVIEW OF OUR COMPLAINT FILE INDICATES THAT THIS IS THE FIRST TIME SUCH A DEFECT IS REPORTED ON PRISMA M100 LOT NUMBER 06A2383G. THE INCRIMINATED SAMPLE IS REQUESTED, BUT NOT STILL REC'D. OUR SUBCONTRACTOR GAMBRO DASCO BLOOD LINE DIVISION WAS CONTACTED FOR A SAME PROBLEM REGARDING ANOTHER MANUFACTURING LOT NUMBER. TWO POSSIBLE CAUSES WERE ASSUMED; - PROBLEM DURING MOULDING OF THE CAP, PROBLEM DURING AUTOMATIC ASSEMBLY OF THE CAP ON THE BODY. AS A CORRECTIVE ACTION, THEY HAVE REINFORCED THE COMMUNICATION WHILE THE WHOLE PERSONNEL INVOLVED IN BOTH MANUFACTURING PROCESS STEPS (IMPLAMENTED MID 09/06). THE RISK ANALYSIS REF JPB/AM 05 0916/2 CONCERNING POD EXPLODING DURING UNLOADING, CAN BE APPLIED TO THE SAMPLE SITE (SAME PRESSURE CONDITION, SAME POSSIBLE REACTIONS). DURING UNLOADING, THE PT IS DISCONNECTED, SO THAT NO BLOOD LEAK IS POSSIBLE. THE ONLY POSSIBLE PROBLEM IS A RISK OF CONTAMINATION FOR THE NURSE. THIS IS THE REASON WHY WE DECIDED TO CONSIDER THIS COMPLAINT AS MDR/MDV REPORTABLE. THE RATE OF COMPLAINTS RELATING OF THIS TYPE OF DEFECT IS VERY LOW.

    Description of Event or Problem · 1

    POTENTIAL MDR - BLOOD LEAK - HAPPENED 4 HOURS INTO TREATMENT. THE NURSE HAD STOPPED THE PUMPS TO REPOSITION THE PRESSURE POD. ONCE SHE UNCLAMPED THE LINES, BLOOD EXPLODED OUT OF THE RED ACCESS PORT WHERE THEY NOTICED A CRACK IN THE RIM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRISMA SET PRISMA M100 PRESET FJK GAMBRO INDUSTRIES 100 PRESET 06A2383G

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other