BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ALARIS PUMP MODULE

    MDR report key: 5943307 · Received September 12, 2016

    Report

    Report Number
    2016493-2016-00696
    Event Type
    Malfunction
    Date Received
    September 12, 2016
    Date of Event
    August 13, 2016
    Report Date
    August 16, 2016
    Manufacturer
    CAREFUSION
    Product Code
    FRN
    PMA / PMN Number
    K950419
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    BIOMEDICAL ENGINEER

    Narratives

    Additional Manufacturer Narrative · 1

    THE AFFECTED DEVICE HAS BEEN RECEIVED AND THE INVESTIGATION IS PENDING. A FOLLOW UP REPORT WILL BE SUBMITTED ONCE THE FAILURE INVESTIGATION HAS BEEN COMPLETED.

    Additional Manufacturer Narrative · 1

    THE CUSTOMER¿S REPORT OF THE DEVICE INFUSING FASTER THAN EXPECTED WAS CONFIRMED. PHYSICAL INSPECTION NOTED THE DEVICE TO BE IN OVERALL FAIR CONDITION WITH THE INSTRUMENT SEAL INTACT. THERE WERE NO ANOMALIES OBSERVED. ANALYSIS OF THE PCU EVENT LOG SHOWS THAT AT 4:14 PM ON (B)(6) 2016 THE MODULE WAS PROGRAMMED TO INFUSE A CUSTOM CONCENTRATION OF MAGNESIUM SULFATE TO INFUSE AT 500 ML/HR WITH A VTBI OF 500 ML. ALTHOUGH IT WAS REPORTED THAT THE INTENDED INFUSION WAS MAGNESIUM SULFATE 20 GM/500 ML TO INFUSE AT 2 GM/HR (50 ML/HR), THE DRUG AMOUNT ENTERED WAS 2000 MG, WHICH MADE THE DOSE 2000 MG AND THE DILUENT VOLUME ENTERED WAS 500 ML, WHICH MADE THE CONCENTRATION 4 MG/ML. DURING PROGRAMMING "YES" WAS SELECTED IN RESPONSE TO THE GUARDRAILS WARNING ¿CONCENTRATION IS BELOW GUARDRAILS LIMIT OF 10 MG/ML. PROCEED?¿ THE INFUSION RAN UNTIL 4:22 PM WHEN THE DEVICE WAS CHANNELED OFF. THE VOLUME RECORDED AS BEING INFUSED DURING THIS PERIOD WAS 59.527 ML. FUNCTIONAL TESTING WAS PERFORMED AND FOUND THE DEVICE TO BE DELIVERING FLUID WITHIN SPECIFICATION. THE ROOT CAUSE OF THE CUSTOMER¿S REPORT OF THE DEVICE INFUSING FASTER THAN EXPECTED WAS IDENTIFIED AS USER PROGRAMMING.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT MAGNESIUM SULFATE 20GM/500ML WAS INFUSING AT 2 GM/HR (50ML/HR) WITH A TOTAL VOLUME OF 500ML. THE PATIENT TOLD THE NURSE SHE THOUGHT SHE WAS GIVEN THE WRONG AMOUNT OF MEDICATION. THE PATIENT WAS REPORTEDLY "SYMPTOMATIC WITH THE NORMAL SYMPTOMS REPORTED FROM PATIENTS ON MAGNESIUM SULFATE." IT WAS LATER CONFIRMED THAT THE PATIENT DID NOT EXPERIENCE ANY HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    593902 ALARIS PUMP MODULE PUMP, INFUSION FRN CAREFUSION 8100

    Patients

    Seq Age Sex Outcome Treatment
    1 32 YR 8100,8015,PRI TUBING, TD (B)(6) 2016