BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    *

    MDR report key: 766989 · Received March 28, 2006

    Report

    Report Number
    766989
    Event Type
    Malfunction
    Date Received
    March 28, 2006
    Date of Event
    February 22, 2006
    Report Date
    March 28, 2006
    Manufacturer
    ZIMMER ORTHOPEDIC SURGICAL PRODUCTS
    Product Code
    CAC
    Product Problem
    Yes
    Report Source
    User Facility report
    Reporter Location
    DE, US

    Narratives

    Description of Event or Problem · 1

    A CELL SAVER UNIT WAS HUNG PER PROTOCOL WITH 550 ML TO INFUSE. THIRTY-THREE MINUTES LATER, A SOUND OF DRIPPING WATER WAS NOTED; THEN A GUSHING SOUND. TURNED IMMEDIATELY AND NOTICED LARGE VOLUME OF BLOOD ON FLOOR AND COMING FROM PORT ON RESERVOIR. CLAMP WAS OPENED AND PORT CAP DISPLACED. THE CLAMP HAD BEEN IN LOCKED POSITION WITH PORT CAP IN PLACE WHEN UNIT HUNG. BLOOD REMAINING IN RESERVOIR LOOKED SEPARATED WITH LAYER OF STRAW COLORED LIQUID ON SURFACE OF RED BLOOD. INFUSION STOPPED AND NS (NORMAL SALINE) HUNG. UNABLE TO DETERMINE BLOOD VOLUME THAT INFUSED. ZIMMER COMPANY REP NOTIFIED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 * AUTOLOGOUS BLOOD COLLECTION SYSTEM CAC ZIMMER ORTHOPEDIC SURGICAL PRODUCTS * *

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR