BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE IV ADMINISTRATION SET

    MDR report key: 2121181 · Received May 4, 2011

    Report

    Report Number
    9616066-2011-00175
    Event Type
    Malfunction
    Date Received
    May 4, 2011
    Date of Event
    April 6, 2011
    Report Date
    April 8, 2011
    Manufacturer
    CAREFUSION CORP.
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VT, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    MFR'S REPORT DATE: (B)(4) 2011. (B)(4). THE CUSTOMER'S REPORT OF LEAK IN TUBING COULD NOT BE CONFIRMED. THE DEVICE WAS REPORTED TO HAVE BEEN DISCARDED BY THE CUSTOMER.

    Description of Event or Problem · 1

    CUSTOMER CONTACTED CAREFUSION TO REPORT: CHEMO (IFOSFAMIDE) SPILL AS A RESULT OF A LEAK IN ALARIS INFUSION SET. CUSTOMER ALSO REPORTED THAT UPON EXAMINATION OF SET, THERE WAS A SMALL LEAK IN THE SOFT TUBING THAT GOES INSIDE THE PUMP MODULE SEVERAL MILLIMETERS BELOW THE HARD PLASTIC BLUE TOP CONNECTOR. PT'S SKIN WAS EXPOSED TO CHEMOTHERAPY AND NEEDED TO BE CLEANED. THE BAG HUNG 14 HOURS BEFORE THE LEAK OCCURRED AND WAS INTENDED TO LAST 24 HOURS. NO PT OR USER HARM REPORTED. NO REPORT OF MEDICAL INTERVENTION REQUIRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS PUMP MODULE IV ADMINISTRATION SET FPA CAREFUSION CORP. 2420-0500 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ALARIS PUMP MODULE: S/N UNK| ALARIS PC UNIT: S/N UNK