BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 4418827 · Received January 7, 2015

    Report

    Report Number
    2016493-2014-00588
    Event Type
    Malfunction
    Date Received
    January 7, 2015
    Date of Event
    November 20, 2014
    Report Date
    November 26, 2014
    Manufacturer
    CAREFUSION CORPORATION
    Product Code
    FRN
    PMA / PMN Number
    K950419
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    VA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). ALTHOUGH REQUESTED, THE AFFECTED PRODUCT HAS NOT BEEN RECEIVED. A FOLLOW UP REPORT WILL BE SUBMITTED WITH INVESTIGATION RESULTS SHOULD THE DEVICES BE RECEIVED FOR EVALUATION.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT A HEPARIN INFUSION (25000 UNITS/ 250 ML) HAD BEEN STARTED AT 18 UNITS PER KG ON (B)(6) 2014 AT 1804 (PRESUMED TO MEAN 18 UNIT/KG/H). AFTER MIDNIGHT THE DOSE WAS DECREASED TO 16 UNIT/KG/H BECAUSE OF AN ELEVATED APTT RESULT. AT 0644 THE NURSE PLACED THE PUMP ON PAUSE PER PROTOCOL BECAUSE THE RESULT WAS STILL ELEVATED. AN HOUR LATER WHEN THE STAFF WENT TO RESTART THE INFUSION, THE MODULE WAS DISCOVERED TO BE PROGRAMMED FOR 18 UNITS/KG, THEREFORE, THE CUSTOMER HAS REQUESTED A LOG REVIEW TO DETERMINE WHETHER IT HAD BEEN INFUSING AT 16 UNIT/KG/H AS INTENDED BETWEEN MIDNIGHT AND 0644 OR WHETHER IT HAD CONTINUED AT 18 UNIT/KG/H THROUGHOUT THE NIGHT. THE CUSTOMER WOULD LIKE THE EVENT LOG REVIEW TO START AT THE TIME THE HEPARIN WAS STARTED ON (B)(6) 2014, APPROXIMATELY 6 PM. THERE WAS NO REPORT OF PATIENT HARM OR MEDICAL INTERVENTION. ALTHOUGH REQUESTED, NO ADDITIONAL PATIENT/EVENT DETAILS WERE PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    13856 ALARIS PUMP MODULE PUMP, INFUSION FRN CAREFUSION CORPORATION 8100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 75 YR ALARIS PC UNIT, SN (B)(4)| ALARIS PUMP MODULE TUBING, MODEL/LOT UNKNOWN,