BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUM A+ (11.3 VERSION) NEW RESTART

    MDR report key: 20006413 · Received August 20, 2024

    Report

    Report Number
    9615050-2024-00618
    Event Type
    Malfunction
    Date Received
    August 20, 2024
    Date of Event
    July 18, 2024
    Report Date
    August 19, 2024
    Manufacturer
    ICU MEDICAL COSTA RICA LTD.
    Product Code
    FRN
    UDI-DI
    M3352079204251
    PMA / PMN Number
    K070398
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    CONCLUSION OF THE CUSTOMER PROTOCOL TEST: THE DEVICE WAS PROGRAMMED ON CHANNEL A TO DELIVER A VOLUME OF 500 ML IN 12 HOURS 30 MINUTES, AT A FLOW RATE OF 40 ML/HR, RESULTING IN 506 ML DELIVERED IN 24 HOURS 25 MINUTES. 500 ML *5% = (+/- 25 ML) WITH A TOLERANCE OF +/- 5%. THE DELIVERY VALUE WAS FOUND TO BE WITHIN THE ALLOWED RANGE. THE DELIVERY ERROR MARGIN WAS + 6 ML. ACCORDING TO THE CUSTOMER'S EXPERIENCE, THE DEVICE GENERATED AN EXCESS SUPPLY IN 1 HOUR OF 500 ML. HOWEVER, THE CUSTOMER'S PROTOCOL TESTS DETERMINED THAT THE DEVICE WORKED 24 HOURS 25 MINUTES WITHOUT INTERRUPTION AND THE INFUSION WAS COMPLETED WITHOUT OVER-DELIVERY OR ALTERATIONS OF THE VALUES. DELIVERING WHAT WAS PROGRAMMED. A KEYBOARD TEST WAS PERFORMED TO VERIFY THAT IT DID NOT SELF-PROGRAM. EACH KEY WORKS CORRECTLY, THE TEST PASSED CORRECTLY. IT CAN BE CONCLUDED THAT DURING THE CUSTOMER PROTOCOL AND PRODUCT VERIFICATION TESTS, THE DEVICE INFUSED CORRECTLY WITHOUT OVER DELIVERIES, DID NOT GENERATE TECHNICAL FAULTS OR ALARMS OR OVERPROGRAMMING CAUSED BY THE KEYBOARD. PROBABLE CAUSE: IT CANNOT BE DETERMINED IF IT WAS A USER ERROR SINCE NO EVENTS WERE FOUND WITH PROGRAMMING WITH A RATE OF 47 ML/HR OR PROGRAMMED DELIVERIES AT 500 ML VOLUME. ACCORDING TO THE CUSTOMER REPORT, THE DEVICE WAS NOT SEGREGATED AT THE TIME OF THE EVENT AND LATER MORE INFUSIONS WERE PROGRAMMED WITH OTHER MEDICATIONS, POSSIBLY ERASING THE EVENTS RELATED TO THE CASE THAT OCCURRED WITH THE PATIENT. INITIAL REPORTER FULL PHONE NUMBER: (B)(6). MODEL NUMBER IS NOT SOLD IN THE US BUT SIMILAR DEVICE IS SOLD UNDER MODEL NUMBER 123918805. THIS PRODUCT'S MODEL NUMBER WAS USED FOR THE DI AND THE 501K.

    Description of Event or Problem · 0

    THE COMPLAINT/EVENT INVOLVED A PLUM A+ (11.3 VERSION) NEW RESTART. IT WAS REPORTED THAT A POTASSIUM CHLORIDE DRIP WAS INSTALLED (NOT LABELED ON THE PUMP). A TOTAL VOLUME OF 500 ML WAS INSTALLED AT 40 CC/H, AND IT WAS REPORTED THAT IN 01 HOUR THE TOTAL VOLUME OF 500 ML WAS INFUSED. THIS OCCURED BETWEEN 9:00 P.M. AND 12:00 A.M. THE INFIRMARY REPORTED THAT THE INFUSION RATE WAS DISPLAYED AT 47 CC/H. THE MESSAGE "CASSETTE ERROR" WAS DISPLAYED, BUT SUBSEQUENTLY OTHER MEDICATIONS CONTINUED TO BE INFUSED, FOR WHICH NO MESSAGE WAS DISPLAYED. THERE WAS NO CLINICAL ALTERATION IN THE PATIENT AFTER THE EVENT AND UNSPECIFIED PERTINENT MEASURES WERE TAKEN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2372288 PLUM A+ (11.3 VERSION) NEW RESTART PUMP, INFUSION FRN ICU MEDICAL COSTA RICA LTD. M3352079204251

    Patients

    Seq Age Sex Outcome Treatment
    1 88 YR Female POTASSIUM CHLORIDE, MFR UNK.