BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    CBC-CONSTAVAC

    MDR report key: 9062 · Received July 29, 1994

    Report

    Report Number
    9062
    Event Type
    Malfunction
    Date Received
    July 29, 1994
    Date of Event
    February 15, 1994
    Report Date
    March 7, 1994
    Manufacturer
    STRYKER BLOOD TECHNOLOGIES
    Product Code
    DTN
    Product Problem
    Yes
    Report Source
    User Facility report

    Narratives

    Description of Event or Problem · 1

    SEE ATTACHED PAGE(S)DEVICE LABELED FOR SINGLE USE. PATIENT MEDICAL STATUS PRIOR TO EVENT: UNKNOWN. THERE WAS NOT MULTIPLE PATIENT INVOLVEMENT.INVALID DATA - ON DEVICE SERVICE/MAINTENANCE. NO DATA - REGARDING DATE LAST SERVICED. SERVICE PROVIDED BY: INVALID DATA. INVALID DATA - SERVICE RECORDS AVAILABILITY.NO IMMINENT HAZARD TO PUBLIC HEALTH CLAIMED. DEVICE USED AS LABELED/INTENDED.DEVICE WAS EVALUATED AFTER THE EVENT. METHOD OF EVALUATION: ACTUAL DEVICE INVOLVED IN INCIDENT WAS EVALUATED, VISUAL EXAMINATION. RESULTS OF EVALUATION: DESIGN - HUMAN FACTORS, INCORRECT TECHNIQUE/PROCEDURE. CONCLUSION: USER ERROR CONTRIBUTED TO EVENT. CERTAINTY OF DEVICE AS CAUSE OF OR CONTRIBUTOR TO EVENT: INVALID DATA. CORRECTIVE ACTIONS: NONE OR UNKNOWN. THE DEVICE WAS DESTROYED/DISPOSED OF.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CBC-CONSTAVAC BLOOD CONSERVATION RESERVOIR DTN STRYKER BLOOD TECHNOLOGIES

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other