BEUDAMED
    FDA Adverse Event Other Summary report: N

    FENWAL BLOOD RECIPIENT SET

    MDR report key: 529217 · Received February 24, 2004

    Report

    Report Number
    6000001-2004-00295
    Event Type
    Other
    Date Received
    February 24, 2004
    Date of Event
    December 5, 2003
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    BRZ
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    LA, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    CUSTOMER REPORTS "AFTER FILLING THE CHAMBER, THE BALL OCCLUDED THE FLOW" DURING USE ON A TRAUMA PT IN THE E.R. REPORTER STATES THE PT'S HEMOGLOBIN AND HEMATOCRIT WERE TESTED UPON THEIR ARRIVAL IN THE E.R. THE HEMOGOBLIN WAS 7.8 AND PT WAS "ACTIVELY BLEEDING" SO THEY WERE TRYING TO ADMINISTER THE BLOOD RAPIDLY. REPORTER STATES THE ACCESS SITE WAS A 21 GAUGE PERIPHERAL CATHETER AND THEY WERE USING A PRESSURE CUFF IN ORDER TO INFUSE THE BLOOD QUICKLY. THEY TESTED THE HEMOGLOBIN AND HEMATOCRIT TWENTY MINUTES LATER AND NOTICED AND THE PT'S HEMOGLOBIN WAS NOT IMPROVING AND DISCOVERED THE NO FLOW SITUATION. REPORTER STATES THEY CHANGED THE SET AND THERE WERE NO FURTHER CONSEQUENCES TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FENWAL BLOOD RECIPIENT SET BLOOD SET WITH STANDARD BLOOD FILTER BRZ BAXTER HEALTHCARE CORP. NA NA01

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN Other