BEUDAMED
    FDA Adverse Event Death Summary report: N

    ZPQNOSTK-SURE TRANS AUTOTRANSFUSION DEVICE

    MDR report key: 515017 · Received March 5, 2004

    Report

    Report Number
    1213643-2004-00016
    Event Type
    Death
    Date Received
    March 5, 2004
    Date of Event
    October 22, 2002
    Report Date
    February 9, 2004
    Manufacturer
    DAVOL SURGICAL INNOVATIONS (JUAREZ/MX)
    Product Code
    CAC
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    ATTORNEY

    Narratives

    Description of Event or Problem · 1

    UNABLE TO TRANSFER BLOOD FROM COLLECTION BOTTLE TO REINFUSION BAG. PT DIES AS A RESULT OF MULTIPLE SYSTEM ORGAN FAILURE CAUSED BY PROLONGED HYPERTENSION, SECONDARY TO HYPOVOLEMIA FROM SURGICAL ARTERIAL LACERATION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ZPQNOSTK-SURE TRANS AUTOTRANSFUSION DEVICE 350101216-SURETRANS CAC DAVOL SURGICAL INNOVATIONS (JUAREZ/MX) * UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 * Death