BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PRISMA SET

    MDR report key: 780825 · Received November 9, 2006

    Report

    Report Number
    8010182-2006-00013
    Event Type
    Malfunction
    Date Received
    November 9, 2006
    Date of Event
    September 26, 2006
    Report Date
    November 8, 2006
    Manufacturer
    GAMBRO INDUSTRIES
    Product Code
    KDI
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    INVALID DATA

    Narratives

    Additional Manufacturer Narrative · 1

    IN ABSENCE OF INCRIMINATED SAMPLE, IT IS DIFFICULT TO DETERMINE THE ROOT CAUSE LEADING TO THE REPORTED DEFECT. NEVERTHELESS, OUR SUBCONTRACTOR GAMBRO DASCO BLOOD LINE DIVISION HAS INVESTIGATED SAMPLES FROM OTHER LOT NUMBERS PRESENTING THE SAME DEFECT. 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 WITH THE WHOLE PERSONNEL INVOLVED IN BOTH MANUFACTURING PROCESS STEPS (IMPLEMENTED MID SEPTEMBER 2006). THE RISK ANALYSIS REF. JPB/AM 05 0916/2 CONCERNING POD EXPLODING DURING UNLOADING, CAN BE APPLIED TO THE SAMPLE SITE (SAME PRESSURE CONDITIONS, SAME POSSIBLE REACTIONS). DURING UNLOADING, THE PATIENT IS DISCONNECTED SO THAT NO BLOOD LEAK IS POSSIBLE. THE ONLY POSSIBLE PROMBLEM 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 TO THIS TYPE OF DEFECT IS VERY LOW: 0.08 PER 10,000 DEVICES (CALCULATED ON THE LAST 12-MONTH PERIOD). ON THE OTHER HAND, NO SAFETY ISSUE WAS REPORTED.

    Description of Event or Problem · 1

    COMPLAINT REPORTED IN SWEDEN.WHEN THE PRISMA SHOULD BE DISCONNECTED, THEY FOLLOW THE INSTRUCTIONS ON THE SCREEN. WHEN ALL THE PRESSURE PODS ARE DISCONNECTED, THEY PRESS "RELEASE SET" AND WHEN THE SET IS BEEING RELEASE, THE NURSE IS SPRAYED WITH BLOOD. WHEN THEY LOOK WERE THE BLOOD CAME FROM, THEY SEE THAT THE MEMBRANE WITH INJECTION PORT IS MISSING FROM THE "OUTFLOW." THERE IS ONLY A HOLE IN THE BLOODLINE. THE MEMBRAN IS FOUND ON THE OTHER SIDE OF THE ROOM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PRISMA SET PRISMA M100 PRESET KDI GAMBRO INDUSTRIES M100 PRESET 06B1465G

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other