BEUDAMED
    FDA Adverse Event Injury Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 3251783 · Received July 17, 2013

    Report

    Report Number
    2016493-2013-00318
    Event Type
    Injury
    Date Received
    July 17, 2013
    Report Date
    June 17, 2013
    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). THE PCU EVENT LOG SHOWS THAT HEPARIN 25000UNIT/500ML WAS PROGRAMMED AS A NON-WEIGHT BASED INFUSION ON (B)(6) 2013 AT 12;27 PM WITH A RATE OF 16ML/HR AND A VTBI OF 450ML. THE INFUSION COMPLETED AT 5:05 PM ON 06/09/2013 AND THE DEVICE WAS CHANNELED OFF. AT 5:07 PM, HEPARIN 25000UNIT/250ML WAS PROGRAMMED AS A WEIGHT BASED DOSE AND THE USER ENTERED 80.3KG FOR THE PT WEIGHT. THE DOSE WAS PROGRAMMED AS 12UNIT/KG/HR, WHICH CALCULATED THE RATE TO 9.64ML/HR. THE DOSE WAS CHANGED EIGHT TIMES, WITH DOSES RANGING FROM 12UNIT/KG/HR TO 22UNIT/KG/HR. THE DEVICE WAS IN USE AT 1947 ON (B)(6) 2013 AND WAS NOT STOPPED OR TURNED OFF. THERE WERE NO LOGGED EVENTS FOR THIS SPECIFIC TIME, HOWEVER, THE EVENT LOG DOES SHOW THE USER CHANGED THE DOSE OF THE HEPARIN INFUSION TO 22UNIT/KG/HR AT 7:36 PM. ON (B)(6) 2013 AT 10:09 AM, HEPARIN 25000/500ML WAS PROGRAMMED USING WEIGHT BASED DOSING. THE DOSE WAS ENTERED AS 16 UNIT/KG/HR, WHICH CALCULATED THE RATE TO 25.7ML/HR. THIS INFUSION RAN UNTIL THE DEVICE WAS CHANNELED OFF AT 10:31 AM.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED A LOG REVIEW TO DETERMINE WHETHER OR NOT A PROGRAMMING ERROR OCCURRED. THE CUSTOMER STATED THAT ON (B)(6) 2013 AT 1947 "THE PUMP MAY HAVE BEEN PROGRAMMED FOR A HEPARIN DRIP 25,000 UNITS IN 0.9% NACL 250 ML BAG. (RATE 15 UNITS/KG/HR X 80.4 KG. ADMIN AMOUNT: 1,206 UNITS/HR), INFUSION RATE 24.1ML/HR. THIS WOULD HAVE CAUSED AN UNDER INFUSION DUE POSSIBLY TO THE WRONG VOLUME OF THE BAG ENTERED IN THE PUMP. THE MD SAID SOMETHING DID NOT MAKE SENSE BECAUSE THE P WAS NOT REACHING THE INTENDED GOAL FOR THE PT/PTT LEVEL. PTT WAS LOWER THAN EXPECTED. INTENDED INFUSION WAS NOT HEPARIN DRIP 25,000 UNITS IN 0.9% NACL 500 ML BAG." ADD'L LAB WORK WAS DONE BUT VALUES WERE NOT PROVIDED. THE CUSTOMER ASKED WHETHER THE CHANNEL FOR THE HEPARIN DRIP WAS STOPPED OR TURNED OFF ON (B)(6) 2013 AT 1947 AND WHETHER THE NURSE SELECTED RESTORE OR PROGRAMMED A NEW SETTING ON (B)(6) 2013 AT 1947. ALTHOUGH REQUESTED, NO FURTHER PT OR EVENT INFO WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    332134 ALARIS PUMP MODULE FRN CAREFUSION CORPORATION 8100 NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK Required Intervention ALARIS PUMP MODULES: SN #(B)(4)| ALARIS PC UNIT: SN #(B)(4)| ALARIS PUMP MODULES: SN #(B)(4)| PUMP MODULE ADMIN SETS: MODELS/LOTS UNK| ALARIS PUMP MODULES: SN #(B)(4)