BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 2091427 · Received May 4, 2011

    Report

    Report Number
    2016493-2011-00301
    Event Type
    Injury
    Date Received
    May 4, 2011
    Date of Event
    February 6, 2011
    Report Date
    April 7, 2011
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K012383
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    MANUFACTURER'S REPORT DATE: 05/04/2011. (B)(4). UNABLE TO DETERMINE THE CAUSE OF THE CUSTOMER'S REPORTED PROBLEM. CUSTOMER STATES THAT THE PRODUCT WILL NOT BE RETURNED AS THE DEVICES WERE NOT SEQUESTERED AND THE SERIAL NUMBERS ARE NOT KNOWN. A FOLLOW UP REPORT WILL BE SUBMITTED IF ADDITIONAL INFORMATION IS OBTAINED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED PATIENT HAD AN UNEXPECTED BLEED. HEPARIN (25,000 UNITS/500ML) SHOULD HAVE BEEN PROGRAMMED AT 1000 UNITS/HR. THE CUSTOMER STATED THAT IT IS EXPECTED THAT THE PUMP WAS PROGRAMMED CORRECTLY; BUT THAT THEY NEED CONFIRMATION OF THAT (HOWEVER, THE DEVICES WERE NOT SEQUESTERED AND SERIAL NUMBERS ARE UNKNOWN). CUSTOMER STATED THAT NO FURTHER PATIENT/EVENT INFORMATION CAN BE RELEASED.

    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 UNKNOWN Other ALARIS PC UNIT: S/N UNKNOWN