BEUDAMED
    FDA Adverse Event Death Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 3923567 · Received July 2, 2014

    Report

    Report Number
    2016493-2014-00330
    Event Type
    Death
    Date Received
    July 2, 2014
    Date of Event
    June 12, 2014
    Report Date
    June 18, 2014
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K950419
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE NOT RECEIVED, LOG REVIEW ONLY. THE CUSTOMER HAS REQUESTED AN EVENT LOG REVIEW. THE EVENT LOGS AND DATA SET HAVE BEEN RECEIVED AND THE EVAL IS PENDING. A F/U REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS ONCE THE EVAL HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED AN OVER INFUSION AND REQUESTED AN EVENT LOG REVIEW TO DETERMINE USER PROGRAMING. THE CUSTOMER REPORTED THE FOLLOWING "DEXTROSE 30% (D30) WITH 125 UNITS OF HEPARIN WAS ORDERED. THE PUMP WAS SET AT 8.2 ML/HR; HOWEVER, WITHIN 2 HOURS, THE NURSE NOTED THE ENTIRE 250 ML BAG WAS GIVEN TO THE PT. THE PT'S EBG (ESTIMATED BLOOD GLUCOSE) WAS GREATER THAN 500". IT WAS SUGGESTED BY THE HOSPITAL BIOMEDICAL ENGINEER THAT IF THE DOOR OF THE PUMP MODULE WAS OPENED AND THE FLOW STOP DID NOT ENGAGE UNREGULATED FLOW COULD OCCUR. THE CUSTOMER REPORTED THE PT SUSTAINED SERIOUS INJURY AND DIED. ALTHOUGH REQUESTED, NO FURTHER PT OR EVENT INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    385632 ALARIS PUMP MODULE INFUSION PUMP FRN CAREFUSION CORPORATION 8100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 1 DA Death| O ALARIS PUMP MODULE ADMIN SET: MODEL/LOT UNK| 250ML BAG OF 30% DEXTROSE (D30) WITH| 125 UNITS OF HEPARIN: MFR/LOT UNK| ALARIS AUTO ID MODULE: SN (B)(4)| ALARIS PC UNIT: SN (B)(4)