BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 19273174 · Received May 8, 2024

    Report

    Report Number
    9615050-2024-00370
    Event Type
    Malfunction
    Date Received
    May 8, 2024
    Date of Event
    March 28, 2024
    Report Date
    May 8, 2024
    Manufacturer
    ICU MEDICAL COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K141789
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AS
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CUSTOMER COMPLAINT WAS CONFIRMED DURING INVESTIGATION. IT WAS FOUND THAT THE DEVICE DISPLAY WAS BLANK AND THERE WAS AN ABNORMAL BURNING SMELL COMING FROM THE DEVICE. DURING INVESTIGATION IT WAS ALSO NOTED THE DEVICE WAS MISSING ALL EXTERNAL LABELLING. IT WAS ALSO FOUND THAT THE FLUID SHIELD AND DOOR ASM WERE BROKEN. DISASSEMBLED DEVICE, FOUND THAT THE POWER SUPPLY PWA HAS MELTED COMPONENTS, FOUND THE CPU CABLE WAS NOT CORRECTLY FITTED TO THE DRIVER PWA, THE DRIVER PWA WAS ALSO NOTED TO HAVE MELTED COMPONENTS AND DAMAGED PINS WHERE THE CPU CABLE WAS INCORRECTLY FITTED. REPLACED DRIVER PWA, RECALIBRATED MECHANISM, REPLACED POWER SUPPLY PWA, REPLACED ALL MISSING LABELLING, REPLACED FLUID SHIELD ASM AND DOOR ASM. RE-ASSEMBLED DEVICE AND TEST. NO FURTHER ISSUES WERE FOUND. PROBABLE CAUSE: PROBABLE CAUSE FOUND TO BE THE CPU CABLE WAS NOT CORRECTLY FITTED TO THE MECHANISM, LIKELY CAUSING THE FAILURE OF THE POWER SUPPLY PWA AND DRIVER PWA TO FAIL AND CAUSE THE BURNING SMELL AND MELTED COMPONENTS ON THE PWA'S PARTS REPLACED: DRIVER PWA, POWER SUPPLY PWA, FLUID SHIELD ASM, DOOR ASM, ALL EXTERNAL LABELLING.

    Description of Event or Problem · 0

    THE EVENT INVOLVED A SHP GRP,DRVR,PLUM360,AUS-NZ-SA - AND THE CUSTOMER REPORTED A DAMAGED LEVER, FRONT AND REAR COVER ¿ REPLACED. AFTER REASSEMBLING, THE DISPLAY FAILED ¿ NOTHING WILL APPEAR ON THE DISPLAY AND WHEN POWERED, BURNING SMELL AND SMOKE COMING OUT OF THE MAIN BOARD AREA. THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    123584 SHP GRP,DRVR,PLUM360,AUS-NZ-SA PUMP, INFUSION FRN ICU MEDICAL COSTA RICA LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown