BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 4011993 · Received July 9, 2014

    Report

    Report Number
    9616066-2014-00679
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Date of Event
    June 19, 2014
    Report Date
    June 30, 2014
    Manufacturer
    CAREFUSION CORP.
    Product Code
    FPA
    PMA / PMN Number
    UNKNOWN
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER'S REPORT DATE: 07/09/2014. (B)(4). ALTHOUGH REQUESTED, DEVICE HAS NOT BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH FAILURE INVESTIGATION RESULTS SHOULD THE DEVICE BE RECEIVED FOR EVALUATION.

    Description of Event or Problem · 1

    AS A CHILD WAS ON HIS WAY TO THE BATHROOM AND TUGGED ON THE LOWER PORTION OF THE TUBING TO PULL THE IV POLE WITH HIM, THE PUMP DETACHED FROM THE PCU AND FELL ON TO THE FLOOR. THE FALL TO THE FLOOR CAUSED THE IV TUBING TO SNAP APART JUST ABOVE THE UPPER FITMENT. APPROXIMATELY, 33ML OF SOLUTION SPLASHED ONTO THE CHILD, HIS MOTHER, THE IV PUMP AND THE FLOOR. ALL APPROPRIATE PRECAUTIONS TO REMOVE CHEMO CONTAMINATION AND CLEAN THE SPILL WERE TAKEN AS PER HOSPITAL PROTOCOL. NO PATIENT HARM OR MEDICAL INTERVENTION OCCURRED. NO FURTHER PATIENT/EVENT INFORMATION WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    402548 ALARIS PUMP MODULE ADMINISTRATION SET IV SET FPA CAREFUSION CORP. UNKNOWN UNKNOWN

    Patients

    Seq Age Sex Outcome Treatment
    1 UNKNOWN ALARIS PC UNIT, SN UNK| PUMP MODULE, SN UNK