BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE ADMINISTRATION SET

    MDR report key: 4214085 · Received August 6, 2014

    Report

    Report Number
    9616066-2014-00786
    Event Type
    Malfunction
    Date Received
    August 6, 2014
    Date of Event
    July 24, 2014
    Report Date
    July 24, 2014
    Manufacturer
    CAREFUSION CORPORATION, SAN DIEGO
    Product Code
    FPA
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). 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 SECONDARY INFUSION BACKED UP INTO THE PRIMARY BAG. THE INFUSION WAS EXPECTED TO LAST FOR 6 HOURS BUT INFUSED IN LESS THAN 1 HOUR. THE NURSE HUNG THE SECONDARY INFUSION AT 1150. AT 1300 THE NURSE WENT IN TO CHECK THE PATIENT'S IV SITE AND FOUND THE SECONDARY BAG EMPTY AND THE PRIMARY BAG BULGING WITH FLUID. THERE WAS NO PATIENT HARM AND NO MEDICAL INTERVENTION WAS REQUIRED. ALTHOUGH REQUESTED, NO ADDITIONAL PATIENT OR EVENT DETAILS WERE PROVIDED BY THE CUSTOMER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    459695 ALARIS PUMP MODULE ADMINISTRATION SET FPA CAREFUSION CORPORATION, SAN DIEGO UNK UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR THERAPY DATE:| SECONDARY TUBING, MFR/MODEL/LOT UNK:| THERAPY DATE:| THERAPY DATE:| ALARIS PUMP MODULE, SN (B)(4), MFR/MODEL/LOT UNK| ALARIS PCU, SN# (B)(4), MFR/MODEL/LOT UNK