BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE IV ADMINISTRATION SET

    MDR report key: 2891030 · Received November 14, 2012

    Report

    Report Number
    9616066-2012-00827
    Event Type
    Malfunction
    Date Received
    November 14, 2012
    Date of Event
    October 23, 2012
    Report Date
    October 31, 2012
    Manufacturer
    CAREFUSION CORP
    Product Code
    FPA
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ALTHOUGH REQUESTED, THE SET HAS NOT BEEN RECEIVED. A F/U REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS SHOULD THE SET BE RECEIVED FOR EVAL.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A PT ON THE ONCOLOGY UNIT WAS RECEIVING ETOPOSIDE IV WHEN THE ALARIS PUMP BEGAN ALARMING FOR AIR. THE NURSE CLAMPED THE TUBING AND REMOVED THE TUBING FROM THE PUMP TO TAP OUT THE SMALL AIR BUBBLES. WHEN THE NURSE STRETCHED THE TUBING TO GUIDE BACK INTO THE PUMP, THE TUBING CAME APART BETWEEN THE BLUE CAP AND THE RUBBER TUBING THAT SITS INSIDE OF THE PUMP. CONSEQUENTLY, A SMALL AMOUNT OF CHEMO SPILLED ON THE NURSES' HANDS. ONLY A FEW DROPS SPILLED ON TO THE FLOOR. THERE WAS NO HARM TO THE PT OR CLINICIAN. NO MEDICAL INTERVENTION WAS REQUIRED. NO FURTHER PT OR EVENT INFO WAS PROVIDED.

    Devices

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

    Patients

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