BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 2122959 · Received June 8, 2011

    Report

    Report Number
    2016493-2011-00365
    Event Type
    Injury
    Date Received
    June 8, 2011
    Date of Event
    May 9, 2011
    Report Date
    May 11, 2011
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K012383
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CT, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    MFR'S REPORT DATE: (B)(4) 2011. (B)(4). THE DEVICE AND TUBING SET HAVE BEEN REC'D, BUT THE EVAL HAS NOT YET BEGUN. A F/U REPORT WILL BE SUBMITTED ONCE THE FAILURE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED AN OVER INFUSION OF HEPARIN. TWENTY FIVE THOUSAND UNITS OF HEPARIN WERE IN A 500ML BAG. RATE WAS 47.56 MLS/ HOUR. THE INFUSION SHOULD HAVE LASTED FOR 10 HOURS BUT AFTER 4.5 HOURS THE BAG WAS EMPTY. PTT TESTING WAS PERFORMED AND THE UNIT RESULT WAS ELEVATED AT 200 SECONDS.

    Devices

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

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Other ALARIS PC UNIT| S/N (B)(4), DATE OF TX (B)(6) - (B)(6) 2011