BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CBC 11 CONSTAVAC

    MDR report key: 3874138 · Received June 10, 2014

    Report

    Report Number
    MW5036594
    Event Type
    Malfunction
    Date Received
    June 10, 2014
    Date of Event
    May 20, 2014
    Report Date
    June 6, 2014
    Manufacturer
    STRYKER
    Product Code
    CAC
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AK, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Description of Event or Problem · 1

    PATIENT CAME FROM SURGERY TO RECOVERY WITH CONSTAVAC. THE NURSE ASKED THE PHYSICIAN WHAT LEVEL TO START AT. WHEN THE NURSE TURNED ON THE DEVICE IT DID NOT FUNCTION. CONNECTION TO PATIENT WAS CHECKED BY NURSE AND EVERYTHING WAS CONNECTED PROPERLY. TURNED DEVICE ON AGAIN BUT IT DID NOT START. CHANGED OUT DEVICE AND THE NEW CONSTAVAC FUNCTIONED PROPERLY. NO HARM TO PATIENT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    338297 CBC 11 CONSTAVAC BLOOD CONSERVATION SYSTEM CAC STRYKER 225-28-104 RCVB 14062012

    Patients

    Seq Age Sex Outcome Treatment
    1 57 YR