BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SABRATEK TUBING (SABRA SET)

    MDR report key: 316077 · Received February 12, 2001

    Report

    Report Number
    MW1021063
    Event Type
    Malfunction
    Date Received
    February 12, 2001
    Date of Event
    February 12, 2001
    Report Date
    February 12, 2001
    Manufacturer
    SABRATEK CORP/BAXTER
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AZ, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    SABRATEK TUBING FOR 6060 PUMP 560-112 GEL LOT #S 001887 AND 001888 LEAK AT THE JUNCTION TO THE CASSETTE CAUSING PUMP TO MALFUNCTION. 5 PTS, MULTIPLE TUBING.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    5221 SABRATEK TUBING (SABRA SET) 6060 TUBING FPA SABRATEK CORP/BAXTER 560-112 GEL 001887, 001888

    Patients

    Seq Age Sex Outcome Treatment
    1 *