BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 4210341 · Received August 8, 2014

    Report

    Report Number
    9616066-2014-00821
    Event Type
    Malfunction
    Date Received
    August 8, 2014
    Date of Event
    June 7, 2014
    Report Date
    July 17, 2014
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ALTHOUGH REQUESTED, THE AFFECTED PRODUCT HAS NOT BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS SHOULD THE AFFECTED PRODUCT BE RECEIVED FOR EVALUATION.

    Description of Event or Problem · 1

    CUSTOMER REPORTED THE IV TUBING SEPARATED FROM THE TOP OF THE UPPER FITMENT AND TPN LEAKED ONTO THE FLOOR. THE INFUSION WAS INFUSING WITH NO PROBLEMS PRIOR TO SHIFT CHANGE, IN WHICH THE NURSE ASSESSED THE DEVICE AND IV SET. THE DEVICE WAS BEEPING APPROXIMATELY 5 MINUTES AFTER THE NURSE LEFT THE ROOM AND WHEN THE NURSE ENTERED THE ROOM THE TPN WAS LEAKING ONTO THE FLOOR. THE TUBING WAS NOTED TO BE SEPARATED FROM TOP OF THE UPPER FITMENT DURING TROUBLESHOOTING AND THE IV SET WAS SEQUESTERED. THE DOCTOR WAS NOTIFIED AND THE APPROPRIATE IV FLUIDS WERE ORDERED. THE PATIENT WAS UP TO THE BATHROOM PRIOR TO THE IV SET SEPARATING. THERE WAS NO REPORT OF PATIENT HARM OR MEDICAL INTERVENTION. NO ADDITIONAL PATIENT OR EVENT DETAILS WERE PROVIDED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    468824 ALARIS PUMP MODULE ADMINISTRATION SET IV INFUSION SET FPA CAREFUSION CORPORATION 2420-0007 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 6 YR ALARIS PUMP MODULE, SN: UNK| ALARIS PCU, SN: UNK