BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 2190056 · Received June 29, 2011

    Report

    Report Number
    2016493-2011-00396
    Event Type
    Malfunction
    Date Received
    June 29, 2011
    Report Date
    May 12, 2011
    Manufacturer
    CAREFUSION CORP
    Product Code
    FRN
    PMA / PMN Number
    K012383
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). RESULTS: UPPER OCCLUDER FINGER. THE REPORTED CUSTOMER COMPLAINT OF RATE INACCURACY AND FAILURE TO CALIBRATE WAS CONFIRMED AND REPLICATED ON THE RETURNED PUMP MODULE. RATE ACCURACY TESTING WAS PERFORMED. THE PUMP MODULE WAS FOUND TO BE OUT OF SPEC AND COULD NOT BE CALIBRATED. INTERNAL INSPECTION FOUND DRIED FLUID ON THE UPPER OCCLUDER FINGER AND IN THE PUMPING FINGER GROVES. EVIDENCE OF PREVIOUS FLUID INGRESS DAMAGE WAS ALSO FOUND ON THE BOTTOM OF THE REAR CASE. THE PUMP MODULE WAS CLEANED OF DRIED FLUID RESIDUE AND REASSEMBLED SO THAT RATE ACCURACY COULD BE RE-EXECUTED. RATE ACCURACY WAS PERFORMED AND THE PUMP MODULE WAS FOUND TO BE IN SPEC AND DID NOT REQUIRE CALIBRATION. THE CAUSE OF THE RATE INACCURACY AND FAILURE TO CALIBRATE WAS DUE TO A STUCK UPPER OCCLUDER FINGER. THE ROOT CAUSE OF THE STUCK OCCLUDER WAS DUE TO DRIED FLUID ON THE UPPER OCCLUDER FINGER.

    Description of Event or Problem · 1

    RECEIVED A REPORT FROM THE SVC DEPOT THAT A DEVICE WAS RECEIVED FOR RATE INACCURACY AND FAILED TO CALIBRATE. CONTACT WITH CUSTOMER REVEALED THAT THE PROBLEM WITH THE PUMP WAS DISCOVERED UPON PRIMING AND WAS NOT ATTACHED TO THE PT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ALARIS PUMP MODULE FRN CAREFUSION CORP 8100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK ALARIS PC UNIT, SN (B)(4)