BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ADULT CPB PACK

    MDR report key: 3934551 · Received June 27, 2014

    Report

    Report Number
    2248146-2014-00112
    Event Type
    Injury
    Date Received
    June 27, 2014
    Date of Event
    May 2, 2014
    Report Date
    May 28, 2014
    Manufacturer
    DATASCOPE CORP.
    Product Code
    DSP
    PMA / PMN Number
    K090533
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE IS NOT AVAILABLE FOR EVALUATION, THEREFORE, THE COMPLAINT COULD NOT BE CONFIRMED. IF THE PRODUCT IS RETURNED OR ADDITIONAL INFORMATION OBTAINED, A SUPPLEMENTAL REPORT WILL BE SUBMITTED. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER STATES THAT DURING UNPLANNED RESUMPTION OF CPB, RESERVOIR VACUUM COULD NOT BE ESTABLISHED TO AUGMENT VENOUS RETURN. CUSTOMER HEARD HISSING SOUND AND ASSUMED RELIEF VALVE ON RESERVOIR OPENED. WHEN PLACING FINGER OVER VALVE, VACUUM IMPROVED SOMEWHAT. PATIENT SUCCESSFULLY SEPARATED FRO CPB WITHOUT INCIDENT. RESERVOIR WAS NOT SAVED AND LOT NUMBER NOT RECORDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    375791 ADULT CPB PACK CARDIOPULMONARY DEVICE DSP DATASCOPE CORP. BO-TOP 19100

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention