BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNSPECIFIED PLUM 360 INFUSION PUMP

    MDR report key: 19945466 · Received August 8, 2024

    Report

    Report Number
    9615050-2024-00587
    Event Type
    Malfunction
    Date Received
    August 8, 2024
    Date of Event
    July 10, 2024
    Report Date
    August 8, 2024
    Manufacturer
    ICU MEDICAL COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K161469
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHARMACIST
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    MULTIPLE ATTEMPTS HAVE BEEN MADE TO OBTAIN THE DEVICE FOR INVESTIGATION, HOWEVER THE DEVICE IS NO LONGER AVAILABLE FOR RETURN. WITHOUT THE RETURN OF THE DEVICE, A PROBABLE CAUSE IS UNABLE TO BE DETERMINED. IF ADDITIONAL INFORMATION OR IF A DEVICE LATER BECOMES AVAILABLE, SUPPLEMENTAL VIGILANCE REPORT(S) WILL BE SUBMITTED AT THAT TIME.

    Description of Event or Problem · 0

    THE COMPLAINT/EVENT OCCURRED ON AN UNSPECIFIED DATE AND INVOLVED UNSPECIFIED PLUM 360 INFUSION PUMPS THAT REPORTEDLY TURNED OFF DURING THE ADMINISTRATION OF CRITICAL IV MEDICATION. THE FACILITY ALLEGED THAT THEY ARE ALSO NOT RECEIVING PUMPS THAT ARE DESIGNED FOR CRITICAL DRIPS AND THIS POSES AN ISSUE BECAUSE NCD PUMPS DO NOT AUDIBLY ALARM. FOR EXAMPLE, THE CUSTOMER STATED THAT 'IF A PATIENT IS RECEIVING MAGNESIUM OR PITOCIN, THIS COULD CAUSE PATIENT HARM'. THERE WAS NO SPECIFIC PATIENT HARM REPORTED AND IT WAS UNKNOWN IF OR HOW LONG THERE WAS ANY DELAY IN THERAPY. THIS EMDR REFLECTS SIX OCCURRENCES OF THE SAME REPORTED ISSUE. ADDITIONAL INFORMATION WAS RECEIVED BY THE CUSTOMER ON 30-JULY-2024 ASKING FOR THE COMPLAINT TO BE CLOSED BECAUSE THE ISSUE WAS CAUSED BY THE INFUSERS NOT BEING PLUGGED IN.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1703856 UNSPECIFIED PLUM 360 INFUSION PUMP PUMP, INFUSION FRN ICU MEDICAL COSTA RICA LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown UNSPECIFIED CRITICAL IV MEDICATION, MFR UNK