BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 2872542 · Received December 5, 2012

    Report

    Report Number
    2016493-2012-00518
    Event Type
    Injury
    Date Received
    December 5, 2012
    Date of Event
    November 24, 2012
    Report Date
    November 26, 2012
    Manufacturer
    CAREFUSION CORP.
    Product Code
    FRN
    PMA / PMN Number
    K950419
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MO, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE EVENT LOG HAS BEEN RECEIVED, HOWEVER WE ARE STILL WAITING FOR THE CUSTOMER'S DATA SET. A F/U REPORT WILL BE SUBMITTED ONCE THE FAILURE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    A NURSE CALLED TO REQUEST AN EVENT LOG REVIEW. SHE STATED THAT ONE OF HER NURSES REPORTED THAT 400CC OF HEPARIN INFUSED INTO A PT IN 30 MINS. HEPARIN WAS PROGRAMMED/STARTED ON (B)(6) 2012 AT 2330. INTENDED RATE WAS 32ML/HR. SHE STATED THAT THE PROGRAMMING WAS CHECKED BY A SECOND NURSE AND WAS REPORTEDLY PROGRAMMED CORRECTLY (NO OTHER DETAILS WERE PROVIDED RELATED TO ORDERED VALUES). THE REPORTER BELIEVES BUT IS NOT 100% CERTAIN THAT THE MEDICATION WAS RUN AS A PRIMARY INFUSION. THE NURSE STATED THAT THE HEPARIN MEDICATION WAS HELD FOR 5 HOURS AND EXTRA PTT BLOOD DRAWS WERE DONE EVERY HOUR. SHE STATED THAT THE PT HAD AN ELEVATED PTT FOR 5 HOURS BEFORE RETURNING TO AN ACCEPTABLE LEVEL TO RESTART THE HEPARIN. THE TUBING WAS SAVED. NO PT HARM WAS REPORTED. CUSTOMER STATES THAT NO FURTHER PT/EVENT INFO IS AVAILABLE.

    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 Required Intervention ALARIS PUMP MODULE ADMIN SET: MODEL/LOT # UNK| ALARIS PC UNIT: SN (B)(4)| ALARIS PUMP MODULE: SN (B)(4)