BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 3253706 · Received July 17, 2013

    Report

    Report Number
    2016493-2013-00314
    Event Type
    Malfunction
    Date Received
    July 17, 2013
    Date of Event
    June 20, 2013
    Report Date
    June 28, 2013
    Manufacturer
    CAREFUSION CORP
    Product Code
    FRN
    PMA / PMN Number
    K950419
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ALTHOUGH REQUESTED THE DEVICE HAS NOT BEEN RECEIVED. A F/U REPORT WILL BE SUBMITTED WITH FAILURE INVESTIGATION RESULTS SHOULD THE DEVICE BE RETURNED FOR EVAL.

    Description of Event or Problem · 1

    CUSTOMER REPORTED AN INTEGRILIN INFUSION (CONCENTRATION 0.75MG/ML) WAS SET TO INFUSE AT 11.7ML/HR AT 11:20PM AND BY 2:00AM THE BOTTLE WAS FOUND EMPTY WITH AIR IN TUBING. THE INTENDED RATE OF INFUSION FOR THE REMAINING 3 HOURS WAS 14ML/HOUR. THE INFUSION SHOULD HAVE RUN UNTIL 3:30AM. NO PT HARM OR MEDICAL INTERVENTION REPORTED. THE CUSTOMER DID NOT PROVIDE ANY ADDITIONAL PT OR EVENT DETAILS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    331745 ALARIS PUMP MODULE FRN CAREFUSION CORP 8100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK 2 ALARIS PUMP MODULE ADMINISTRATION SETS:| ALARIS PC UNIT: SN (B)(4)| ALARIS PUMP MODULE: SN (B)(4)| MODEL/LOT UNK