BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 1935377 · Received December 15, 2010

    Report

    Report Number
    2016493-2010-00488
    Event Type
    Injury
    Date Received
    December 15, 2010
    Date of Event
    September 10, 2010
    Report Date
    November 15, 2010
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K012383
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). PRODUCT WAS EVALUATED AND CUSTOMER'S REPORT OF EMPTY BAG (OVERINFUSION) OF HEPARIN WAS NOT CONFIRMED. A REVIEW OF THE EVENTS FOUND IN THE DEVICE'S LOGS INDICATES THAT THE INFUSION WAS PROGRAMMED, AS REPORTED, FOR A RATE OF 9 ML/HR AND RAN FOR APPROX 3 1/2 HOURS. A TOTAL OF 27.61 MLS WAS RECORDED TO HAVE BEEN INFUSED OVER THE DURATION OF THE INFUSION. IT WAS NOTED THAT ALMOST IMMEDIATELY AFTER STARTING THE INFUSION, THE USER RECEIVED A PUMP CHAMBER BLOCKED MESSAGE FOR UNK REASONS. ALSO NOTED WAS THE FACT THAT THE USER CHANGED THE VTBI TO 10 MLS NEAR THE END OF THE INFUSION THEN BACK TO 221 MLS A COUPLE HOURS AFTER THE INFUSION HAD BEEN TERMINATED. FUNCTIONAL TESTING ON THE DEVICE AND THE RETURNED DISPOSABLE SET FOUND THE SYSTEM TO BE IN GOOD CONDITION AND DELIVERING FLUID WITHIN SPECIFICATIONS AT THE INCIDENT RATE OF 9 ML/HR. NOTE: THE RETURNED BAG WAS LABELED HEPARIN 100 UNITS/ML. THE ROOT CAUSE OF THE REPORTED EVENT WAS NOT DETERMINED.

    Description of Event or Problem · 1

    CUSTOMER REPORTED PATIENT WAS STARTED ON 250 CC BAG OF HEPARIN INFUSION VIA PUMP AT 1900HRS. AT 2100HRS, RN WENT TO THE ROOM AND NOTICED IV BAG WAS EMPTY. RATE AND VOLUME WERE CHECKED ON PUMP, THE NUMBERS WERE CORRECT, THE RATE WAS 9CC/HR AND VOLUME TO BE INFUSED WAS 221MLS. PT WAS TREATED WITH PROTAMINE SULFATE AND RETURNED TO BASELINE FOLLOWING EVENT. NO ADD'L INFO WAS AVAILABLE.

    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 Required Intervention ALARIS PUMP MODULE ADMINISTRATION SET:| MODEL 2426-0500| ALARIS SYSTEM PC UNIT, (B)(4)