BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 4230481 · Received October 22, 2014

    Report

    Report Number
    9616066-2014-01048
    Event Type
    Malfunction
    Date Received
    October 22, 2014
    Date of Event
    September 12, 2014
    Report Date
    October 3, 2014
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FPA
    PMA / PMN Number
    UNK
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    UT, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT WAS FILED BY THE MANUFACTURER. 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

    THE CUSTOMER REPORTED THAT THE IV TUBING SET TIP BROKE AT A CONNECTION WITH A HOSPIRA SET. 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
    670871 ALARIS PUMP MODULE ADMINISTRATION SET IV INFUSION ET FPA CAREFUSION CORPORATION UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK HOSPIRA MICROBORE EXT SET: MODEL 12657, LOT UNK