BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 19805174 · Received July 23, 2024

    Report

    Report Number
    9615050-2024-00558
    Event Type
    Malfunction
    Date Received
    July 23, 2024
    Date of Event
    June 12, 2024
    Report Date
    July 23, 2024
    Manufacturer
    ICU MEDICAL COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K141789
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ENGINEERING EVALUATES THAT, CONTRARY TO CUSTOMER¿S ASSERTION THAT ¿WERE NO ERRORS IN PROGRAMMING THE INFUSION¿, THE CLINICIAL DID CHANGE THE FINAL INFUSION, IN MID-DELIVERY, FROM A ¿RATE OF 250 ML/HR OVER 2 HRS¿ TO A ¿VTBI OF 250 ML OVER 2 HRS (CALCULATED RATE 125 ML/HR)¿. ENGINEERING FURTHER EVALUATES THAT THE COMBINED INFUSION COMPLETED ABOUT 97 MIN BECAUSE (A) THE 1ST PART WAS RUN AT TWICE THE INTENDED RATE (250 ML/HR INSTEAD OF 125 ML/HR), AND (B) A PORTION OF THE BAG VOLUME MAY HAVE BEEN USED IN PRIMING THE PLUM SET. BECAUSE, AS NOTED ABOVE, THE ACTUAL DELIVERY VOLUME CALCULATES (BASED ON THE RATE AND DURATION FOR EACH SEGMENT) TO WITHIN 3.9% OR BETTER BY VOLUME WHICH IS WITHIN THE PUMP¿S DESIGNED TOLERANCE OF +/- 5.0%, ENGINEERING EVALUATES THAT THE PUMP PERFORMED CORRECTLY AS PROGRAMMED PER DESIGN. THE ALLEGED COMPLAINT IS NOT CONFIRMED. THE DEVICE ALL PVT TESTING INCLUDING DELIVERY ACCURACY TESTING.THE COMPLAINT IS NOT CONFIRMED.

    Description of Event or Problem · 0

    THE EVENT INVOLVED A PLUM 360¿ INFUSION PUMP WHERE IT WAS REPORTED THAT THE FLOW RATE ACHIEVED DOES NOT CORRESPOND TO THE REQUESTED FLOW RATE. THE EVENT OCCURRED DURING INFUSION, THE INFUSION STARTED AT AROUND 10 A.M. ON JUNE 12 WITH THE DURATION OF 2H HAVING THE FOLLOWING PARAMETERS PROGRAMMED: 250ML IN 2H, THE ISSUE WAS OBSERVED AT THE END OF THE INFUSION, THE PATIENT REPORTED THAT THE PRODUCT IS PASSING TO FAST, INSTEAD OF 2H THE PRODUCT WAS ADMINISTERED IN 1H AND 30 MINUTES. THE CUSTOMER STATED THAT 0ML OF LIQUID/PRODUCT REMAINED IN THE CONTAINER, NOBODY WAS HARMED, NO ADVERSE EVENTS, NO DELAY IN THERAPY AND ADDITIONAL MEDICAL INTERVENTION WAS NOT REQUIRED. THE CUSTOMER STATED THAT THERE WERE NO ERRORS IN PROGRAMMING THE INFUSION, NO PHYSICAL IMPACT OF FORCE ON THE PUMP, NO PHYSICAL DAMAGES ON THE PUMP, THE HISTORY / EVENT LOG WERE NOT REVIEWED BY THE CUSTOMER , A FILTER WAS NOT USED AND THE CUSTOMER STATED THEY DO NOT HAVE INFORMATION REGARDING THE TUBING SET LOT/LIST NUMBERS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    906348 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 NA Unknown UNSPECIFIED MEDICATION, UNKNOWN MFR.