BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SABRATEK 6060

    MDR report key: 159137 · Received March 20, 1998

    Report

    Report Number
    MW1013374
    Event Type
    Malfunction
    Date Received
    March 20, 1998
    Date of Event
    March 18, 1998
    Report Date
    March 19, 1998
    Manufacturer
    SABRATEK CORP.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    MD, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Description of Event or Problem · 1

    A BAG OF 5FU BEING INFUSED AT 1ML/HR FOR 96 HRS. INFUSION PUMP READING 89.7 INFUSED, OUT OF 96 ML W/12 ML OVERFILL; BAG DRY; AIR IN TUBING ABOVE FILTER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SABRATEK 6060 INFUSION PUMP FRN SABRATEK CORP. 6060 *

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Other