BEUDAMED
    FDA Adverse Event Death Summary report: N

    PLUER-EVAC SAHARA RAPID TRANSFER BAG 10/BX

    MDR report key: 3804453 · Received April 28, 2014

    Report

    Report Number
    3004365956-2014-00164
    Event Type
    Death
    Date Received
    April 28, 2014
    Date of Event
    March 26, 2014
    Report Date
    March 31, 2014
    Manufacturer
    TELEFLEX MEDICAL
    Product Code
    PAD
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    THE DEVICE HISTORY RECORD HAS BEEN REVIEWED AND NO ISSUES OR DISCREPANCIES WERE FOUND, WHICH COULD POTENTIALLY RELATE TO THIS COMPLAINT. NO REJECTION REPORT WAS ORIGINATED FOR THE LOT IN QUESTION THAT CAN BE ASSOCIATED TO THE COMPLAINT REPORTED. DHR SHOWS THAT THE PRODUCT WAS ASSEMBLED AND INSPECTED ACCORDING TO OUR SPECIFICATIONS. A HISTORY REVIEW WAS CONDUCTED FOR SIMILAR COMPLAINTS FOR CATALOG #S-250-08, AND NO PREVIOUS COMPLAINTS WERE FOUND THAT RELATE TO THE REPORTED ISSUE. DEVICE SAMPLE RECEIVED BY MANUFACTURER, BUT INVESTIGATION IS STILL UNDERWAY AT TIME OF THIS REPORT.

    Description of Event or Problem · 1

    COMPLAINT ALLEGES: DURING A RE-INFUSION PROCEDURE, THE RNS (REGISTERED NURSES) SAID THEY SQUEEZED THE BAGS REPEATEDLY BUT THE BLOOD DID NOT SEEM TO FLOW. THE BAGS FILLED EASILY, BUT THEY HAD TROUBLE GETTING THE BLOOD OUT OF THE BAG. ADDITIONAL INFORMATION RECEIVED: THE PT WAS GETTING TRANSFUSED DUE TO ACUTE BLOOD LOSS FROM A GUNSHOT WOUND TO THE CHEST. THE PT IS DECEASED. THE MEDICAL INTERVENTIONS PERFORMED WERE: CHEST THORACOTOMY, BLOOD TRANSFUSIONS, CHEST TUBE, IV FLUIDS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    254415 PLUER-EVAC SAHARA RAPID TRANSFER BAG 10/BX TRANSFER BAG PAD TELEFLEX MEDICAL 02G1202875

    Patients

    Seq Age Sex Outcome Treatment
    1 Death