BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PUMP SET FOR MEDMATE INFUSION SYSTEM

    MDR report key: 27894 · Received November 6, 1995

    Report

    Report Number
    MW1007594
    Event Type
    Malfunction
    Date Received
    November 6, 1995
    Date of Event
    September 15, 1995
    Report Date
    October 27, 1995
    Manufacturer
    PATIENT SOLUTIONS, INC.
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    FL, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    PUMP BAG LEAKED DURING FILL WITH 5-FLUROURACIL. PROBLEM APPEARS TO BE A DEFECTIVE SEAM SECONDARY TO POSSIBLE MISALIGNMENT IN MFG.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 PUMP SET FOR MEDMATE INFUSION SYSTEM PUMP SET FPA PATIENT SOLUTIONS, INC. 50403A

    Patients

    Seq Age Sex Outcome Treatment
    1 *