BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SHP GRP,DRVR,PLUM360,AUS-NZ-SA

    MDR report key: 8855225 · Received August 2, 2019

    Report

    Report Number
    9615050-2019-00324
    Event Type
    Injury
    Date Received
    August 2, 2019
    Date of Event
    July 16, 2019
    Report Date
    July 16, 2019
    Manufacturer
    ICU MEDICAL COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K141789
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    CUSTOMER COMPLAINT WAS CONFIRMED DURING INVESTIGATION. PLUGGED PUMP INTO MAINS POWER. TURNED ON PUMP AND FOUND PUMP TO TURN ON NORMALLY. CHARGED PUMP TO FULL BATTERY. DISCONNECTED MAINS POWER AND TURN ON PUMP, INSERTED PRIMED TEST CASSETTE, SET PUMP TO RUN CUSTOMER PROTOCOL. DELIVERY RATE 7.9 ML/H, VOLUME TO BE INFUSED (VTBI) 53.8ML FOR A RUN TIME OF 6 HOURS 48 MINUTES. DURING DELIVERY ROUGHLY 4 HOURS AFTER STARTING IT WAS NOTICED ON THE PUMP THAT THE DEVICE WAS TURNING ITSELF ON AND OFF AGAIN REPEATEDLY WITH NO ALARMS. THERE WAS NO LOW BATTERY WARNINGS OR ALARMS BEFORE THIS HAPPENED, THIS WAS REPEATED TWICE WITH THE SAME RESULT. ONCE DEVICE WAS PLUGGED BACK INTO MAINS POWER THE DEVICE WOULD POWER ON NORMALLY. REPLACED THE BATTERY ASSEMBLY (ASM) AND CHARGED BATTERY OVERNIGHT. STARTED THE CUSTOMER PROTOCOL AGAIN WITH THE NEW BATTERY ON BATTERY POWER, THE PROTOCOL RAN FOR ENTIRE DELIVERY WITH NO FURTHER UNEXPECTED SHUTDOWNS. CHARGED BATTERY TO FULL AND SET TO RUN AT 25ML/H FOR 7 HOURS AS PER TECHNICAL SERVICE MANUAL (TSM) BATTERY SPECIFICATION WITH NO FURTHER ISSUES. PROBABLE CAUSE DETERMINED TO BE A DEFECTIVE BATTERY. NOTE BATTERY REMOVED FROM PUMP WAS NOT A ICU MEDICAL SUPPLIED BATTERY.

    Additional Manufacturer Narrative · 1

    THE DEVICE IS AVAILABLE FOR INVESTIGATION. IT IS YET TO BE RECEIVED.

    Description of Event or Problem · 1

    ON (B)(6) 2019, A PLUM 360 DEVICE EXPERIENCED AN UNCONTROLLED SHUTDOWN AND THE SCREEN WENT BLANK. THE EVENT OCCURRED IN THE ACUTE CLINICAL SPECIALTY SERVICES/ANESTHESIA DEPARTMENT AND THE MEDICATION BEING DELIVERED AT THE TIME OF SHUTDOWN WAS NORADRENALINE. THE CLINICIAN NOTICED A MASSIVE DROP IN THE ARTERIAL BLOOD PRESSURE TO SBP (SYSTOLIC BLOOD PRESSURE) IN THE 50MMHG. THE NORADRENALINE PUMP WAS CHECKED AND IT WAS NOTED TO BE IN THE MIDDLE OF TURNING ON, THE PUMP THEN SWITCHED OFF AGAIN. DURING THIS TIME A RESCUE DOSE OF METARAMINOL 0.5MG IV WAS ADMINISTERED. THE NORADRENALINE CASSETTE WAS CHANGED INTO A NEW PUMP AND THE INFUSION WAS RESTARTED AT 12MG/MIN; THE NURSE TITRATED TO MAP (MEAN ARTERIAL PRESSURE) >65. THE PUMP DID NOT AUDIBLY ALARM PRIOR TO POWERING OFF AND AC POWER WAS BEING USED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    652089 SHP GRP,DRVR,PLUM360,AUS-NZ-SA PUMP, INFUSION FRN ICU MEDICAL COSTA RICA LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 Life Threatening| R METARAMINOL, UNK MFR| NORADRENALINE, UNK MFR| METARAMINOL, UNK MFR| NORADRENALINE, UNK MFR