BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    FENWAL BLOOD RECEPIENT SET

    MDR report key: 634705 · Received June 8, 2005

    Report

    Report Number
    6000001-2005-01954
    Event Type
    Malfunction
    Date Received
    June 8, 2005
    Date of Event
    May 22, 2005
    Report Date
    June 3, 2005
    Manufacturer
    BAXTER HEALTHCARE CORP.
    Product Code
    KSB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WV, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    REPORT RECEIVED OF TUBING SEPARATION. THE FACILITY'S SAFETY OFFICER REPORTED THAT AFTER A BAG OF PLATELETS WAS SPIKED, THE TUBING SEPARATED DIRECTLY BELOW THE SPIKE. APPROXIMATELY 30-40CC'S OF PLATELETS LEAKED AT THE SEPARATION SITE. NO PATIENT INJURY OR MEDICAL INTERVENTION NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 FENWAL BLOOD RECEPIENT SET BLOOD SET WITH STANDARD BLOOD FILTER KSB BAXTER HEALTHCARE CORP. NA UR265694

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN