BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 17277646 · Received July 7, 2023

    Report

    Report Number
    9615050-2023-00229
    Event Type
    Malfunction
    Date Received
    July 7, 2023
    Date of Event
    June 19, 2023
    Report Date
    June 19, 2023
    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
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    IT IS UNKNOWN IF THE DEVICE IS AVAILABLE FOR EVALUATION. THE DEVICE HAS BEEN REQUESTED TO BE RETURNED, HOWEVER, IT HAS NOT BEEN RECEIVED. WITHOUT THE RETURNED DEVICE, PROBABLE CAUSE IS UNABLE TO BE DETERMINED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PLUM 360 INFUSION PUMP GOT STUCK ON THE MAXIMUM SPEED DURING THE INFUSION OF A BOLUS AND ASKED THAT THE LIBERAL NURSE TURN IT OFF AND ON DURING PATIENT USE. THERE WAS NO HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    497184 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 FLUID, UKN MFR