BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    POMPE À PERFUSION PLUM 360¿, COMPATIBLE AVEC LE LOGICIEL ICU MEDICAL MEDNET¿

    MDR report key: 14580816 · Received June 2, 2022

    Report

    Report Number
    9615050-2022-00109
    Event Type
    Malfunction
    Date Received
    June 2, 2022
    Date of Event
    May 1, 2022
    Report Date
    May 23, 2022
    Manufacturer
    ICU MEDICAL COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K161469
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE IS EXPECTED TO BE RETURNED FOR EVALUATION. IT HAS NOT BEEN RECEIVED.

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS RECEIVED FOR EVALUATION. ENGINEERING EVALUATES THE FINAL INFUSION (WHICH WAS STOPPED BY MANUAL USER ACTION ON (B)(6) 2022 @ 04:07 AFTER DELIVERING JUST (B)(4) OF THE PROGRAMMED BAG) IS PROBABLY THE INFUSION THAT RESULTED IN THE CUSTOMER COMPLAINT. BASED ON THIS EVALUATION, THE COMPLAINT IS CONFIRMED. HOWEVER, THE CAUSE OF DELIVERING (B)(4) OF PROGRAMMED VOLUME IN THIS INSTANCE IS CONFIRMED TO BE MANUAL USER ACTION (PRESSING THE [STOP] BUTTON). ENGINEERING EVALUATES THE DEVICE PERFORMED CORRECTLY AS PROGRAMMED AND OPERATED. THE DEVICE FAILED CASSETTE TEST AS DEVICE FAILED TO POWER UP ON BATTERY. THE BATTERY WAS FOUND TO BE FULLY DEPLETED AND WAS REPLACED. THE DEVICE THEN POWER UP ON BATTERY POWER AND AC MAINS AND PASSED CASSETTE TEST AND ALL PVT TESTING INCLUDING DELIVERY ACCURACY TESTING. NO UNEXPECTED AIR IN LINE ALARMS WERE OBSERVED DURING PVT TESTING. ON 1ST JULY 2022, THE DEVICE WAS PROGRAMMED TO RUN AT CUSTOMERS PROTOCOL (AS PER NOTED LOG ENTRY (B)(6) 2022, TIME 04:04:16 = (B)(4) ). EQUIPMENT USED (PRI SET 14000 LOT 4766184, SEC SET 14028 LOT 5206110. SCALES CPN-017). THE DEVICE COMPLETED DELIVERY WITHOUT ISSUE DELIVERING (B)(6) . IT IS CONCLUDED THAT THE COMPLAINT OF RATE ISSUE. HALF OF BAG WAS DELIVERED WAS - NOT CONFIRMED AS NO FAULT FOUND WITH DEVICE. DEVICE OPERATED AS INTENDED. NO PROBABLE CAUSE DETERMINED. THE CUSTOMER¿S COMPLAINT OF BATTERY OUT OF SERVICE WAS CONFIRMED. ADDITIONAL INFORMATION: A5 - ETHNICITY AND A6 - RACE. ALSO D9 - DATE RETURNED TO MFG IS 6/13/2022.

    Description of Event or Problem · 0

    THE EVENT OCCURRED ON AN UNSPECIFIED DATE IN MAY WHICH INVOLVED A PLUM 360¿ INFUSION PUMP WHERE IT WAS REPORTED A RATE ISSUE. HALF OF THE BAG WAS DELIVERED, AND BATTERY IS OUT OF SERVICE. THERE IS NO REPORT OF PATIENT INVOLVEMENT OR PATIENT HARM. NO ADDITIONAL INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    865291 POMPE À PERFUSION PLUM 360¿, COMPATIBLE AVEC LE LOGICIEL ICU MEDICAL MEDNET¿ PUMP, INFUSION FRN ICU MEDICAL COSTA RICA LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown UNSPECIFIED SOLUTION BAG, MFR UNK