BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 5278591 · Received December 9, 2015

    Report

    Report Number
    9616066-2015-01801
    Event Type
    Malfunction
    Date Received
    December 9, 2015
    Date of Event
    November 19, 2015
    Report Date
    November 23, 2015
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    PMA / PMN Number
    K944320
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: BAXTER 500ML IV BAG OF 0.9% NACL, LOT C992958, EXP. 01/17, THERAPY DATE (B)(6) 2015. THE CUSTOMER¿S REPORT OF A LEAK AT THE FILTER WAS CONFIRMED. FUNCTIONAL TESTING WAS PERFORMED AND NO LEAKS WERE OBSERVED. HOWEVER, VISUAL INSPECTION SHOWED THAT THE FILTER MEMBRANE APPEARED TO BE DAMAGED. PRESSURE TESTING WAS PERFORMED AND LEAKING FROM THE PROXIMAL FILTER VENT WAS NOTED AT 5PSI . THE ROOT CAUSE OF THE FILTER LEAK WAS NOT IDENTIFIED.

    Additional Manufacturer Narrative · 1

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

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT WHILE A NURSE WAS INFUSING ETOPOSIDE A LEAK WAS NOTED AT THE FILTER. THE PATIENT CAME IN CONTACT WITH THE CHEMOTHERAPY MEDICATION WHEN HE TOUCHED THE LEAKING FILTER. THE APPROPRIATE INTERVENTIONS WERE TAKEN TO AVOID PATIENT HARM. NO LASTING HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    807788 ALARIS PUMP MODULE ADMINISTRATION SET SET, ADMINISTRATION, INTRAVASCULAR FPA CAREFUSION 10010454

    Patients

    Seq Age Sex Outcome Treatment
    1