BEUDAMED
    FDA Adverse Event Injury Summary report: N

    CD

    MDR report key: 20350 · Received October 18, 1994

    Report

    Report Number
    2243621-1994-00424
    Event Type
    Injury
    Date Received
    October 18, 1994
    Date of Event
    July 30, 1994
    Report Date
    October 3, 1994
    Manufacturer
    ALTHIN MEDICAL
    Product Code
    FKB
    Adverse Event
    Yes
    Report Source
    Distributor report
    Reporter Location
    FL, US
    Reporter Occupation
    OTHER

    Narratives

    Description of Event or Problem · 1

    FACILITY ALLEGES SPONTANEOUS DISCONNECTION OF BLOOD LINDURING REUSE. CHIEF TECH REPORTS ARTERIAL LINE BLOW OFF DURING TREATMENT. ESTIMATED ED BLOOD LOSS 400 CC. NO PATIENT INJURY ORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 CD BLOOD PORT ADAPTER FKB ALTHIN MEDICAL C188

    Patients

    Seq Age Sex Outcome Treatment
    1 * Required Intervention