BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MAXPLUS EXTENSION SET

    MDR report key: 5224624 · Received November 15, 2015

    Report

    Report Number
    9616066-2015-01553
    Event Type
    Malfunction
    Date Received
    November 15, 2015
    Report Date
    October 15, 2015
    Manufacturer
    CAREFUSION
    Product Code
    FPA
    PMA / PMN Number
    K083472
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: HOSPIRA EXTENSION SET: MODEL 19116-28 AND LOT 53059NS; THERAPY DATE UNK. UNABLE TO DETERMINE THE CAUSE OF THE CUSTOMER'S REPORTED COMPLAINT BECAUSE THE SET HAS BEEN DISCARDED BY THE CUSTOMER AND WILL NOT BE RETURNED. THE ROOT CAUSE OF THIS FAILURE COULD NOT BE IDENTIFIED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THEY HAVE HAD SEVERAL EVENTS OF LEAKING AT THE NON-CAREFUSION EXTENSION SET AND MAXPLUS CLEAR CONNECTION IN THE CARDIAC CATH. WHEN A LEAK IS IDENTIFIED THE USER REPLACES THE NON-CAREFUSION EXTENSION SET AND THE LEAKING STOPS. 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
    754104 MAXPLUS EXTENSION SET SET, ADMINISTRATION, INTRAVASCULAR FPA CAREFUSION MP5301-C

    Patients

    Seq Age Sex Outcome Treatment
    1