BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MEDICATION CASSETTE RESERVOIR/EXTENSION SET ANTI-SIPHON VALV

    MDR report key: 752519 · Received September 13, 2005

    Report

    Report Number
    MW1036612
    Event Type
    Malfunction
    Date Received
    September 13, 2005
    Report Date
    September 13, 2005
    Manufacturer
    *
    Product Code
    FPA
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Description of Event or Problem · 1

    PATIENT RECEIVING CONTINOUS IV INFUSION OF 5-FU, PRODUCT SENT OUT USING SMITHS MEDICAL MEDICATION CASSETTE RESERVOIR AND CADD EXTENSION WITH INTEGRAL ANTI-SIPHON VALVE, CHEMOTHERAPY LEAK ASSOCIATED WITH USE OF EXTENSION SET LEAKING AT LUER LEAK CONNECTION-, SMITHS MEDICAL PUT TOGETHER A CUSTOMER INFORMATION BULLETIN ON 3-24-05 THIS INFORMATION WAS NEVER RELAYED TO HOMECARE CO, AND WE HAVE EXPERIENCED SEVERAL CHEMO LEAKS IN PATIENTS' HOMES DUE TO THIS ISSUE NOT BEING PROPERLY ADDRESSED BY SMITHS MEDICAL. IT WASN'T UNTIL HOMECARE CO CONTACTED SMITHS MEDICAL FOR POSSIBLE DEFECTIVE EQUIPMENT, THE COMPANY FAXED A CUSTOMER INFORMATION BULLENTIN TO HOMECARE CO WITH "CORRECTIVE" ACTION PLAN. EVEN AFTER FOLLOWING CORRECTIVE ACTION PLAN OUTLINED IN BULLETIN, CHEMOTHERAPY LEAKS STILL OCCURRED AT EXTENSION CONNECTIONS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 MEDICATION CASSETTE RESERVOIR/EXTENSION SET ANTI-SIPHON VALV MED CASSETTE/EXTENSION TUBING FPA * SEE BELOW *
    2 MEDICATION CASSETTE RESERVOIR/EXTENSION SET ANTI-SIPHON VALV MED CASSETTE/EXTENSION TUBING FPA * SEE BELOW *

    Patients

    Seq Age Sex Outcome Treatment
    1 46 YR