BEUDAMED
    FDA Adverse Event Death Summary report: N

    PLUM 360¿ INFUSER

    MDR report key: 14702656 · Received June 15, 2022

    Report

    Report Number
    9615050-2022-00118
    Event Type
    Death
    Date Received
    June 15, 2022
    Date of Event
    May 20, 2022
    Report Date
    May 24, 2022
    Manufacturer
    ICU MEDICAL COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K161469
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    OH, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RETURNED FOR EVALUATION. WITHOUT THE RETURN OF THE SAMPLE A COMPREHENSIVE FAILURE INVESTIGATION CANNOT BE PERFORMED, AND A CAUSE CANNOT BE DETERMINED.

    Additional Manufacturer Narrative · 0

    A COMPLAINT WAS RECEIVED REGARDING A PLUM 360 INFUSION PUMP IN WHICH THE REPORTER STATED THAT THE PUMP WAS BEING USED ON A PATIENT DURING CODE BLUE. THE PUMP DISPLAYED AN ERROR MESSAGE ¿POWER OFF THEN ON, REPLACE PUMP IF ALARM CONTINUES.¿ THE STAFF CHANGED TO ANOTHER PUMP AND DISPLAYED THE SAME ERROR, AND IT WAS REPORTED THE PATIENT DIED. THE USER FACILITY STATED THAT THEY CHECKED THE EVENT LOG BUT FOUND NO ERROR AND THE PUMP WAS NOT RETURNED FOR EVALUATION, THEREFORE, NO VISUAL INSPECTION AND FUNCTIONAL TESTING WERE PERFORMED TO DETERMINE IF THE DEVICE PLAYED A ROLE IN THE ADVERSE EVENT. THE 12-MONTH SERVICE HISTORY WAS REVIEWED, AND NO PREVIOUS COMPLAINTS WERE REPORTED. ICU MEDICAL, INC. TRIED TO OBTAIN THE PUMP'S SERVICE REPAIR HISTORY, BUT THE CUSTOMER DID NOT RESPOND TO THIS REQUEST FOR INFORMATION. THE CUSTOMER DECLARED THAT THE PUMP WAS NOT AT FAULT, AND THAT THERE WAS CLAMPING OF A TUBING ON THE DISTAL SIDE OF THE PUMP. THE PUMP IS CURRENTLY IN THEIR BIOMED OFFICE AND IS FUNCTIONING NORMALLY AND DOES NOT NEED TO BE SENT IN FOR FURTHER EVALUATION. IT CAN BE CONCLUDED THAT THE DEVICE DID NOT PLAY A ROLE IN THE ADVERSE EVENT. THE DEVICE WAS NOT RETURNED TO THE SERVICE HUB FOR ANALYSIS AND EVALUATION, NO VISUAL INSPECTION AND FUNCTIONAL TESTING WERE PERFORMED. ADDITIONAL INFORMATION A5, A6

    Description of Event or Problem · 0

    THE EVENT INVOLVED A PLUM 360 INFUSION PUMP THAT WAS BEING USED ON A PATIENT DURING CODE BLUE. THE PUMP DISPLAYED AN ERROR MESSAGE ¿POWER OFF THEN ON, REPLACE PUMP IF ALARM CONTINUES¿. THE STAFF CHANGED TO ANOTHER PUMP AND DISPLAYED THE SAME ERROR AND THE PATIENT DIED. THE CUSTOMER CHECKED THE EVENT LOG BUT FOUND NO ERROR. THE CUSTOMER ALSO REPORTED THAT THEIR FACILITY DID AN INTERNAL INVESTIGATION AND THE RESULT WAS THAT PUMP WAS NOT AT FAULT; DURING THE CODE, AT THE DISTAL SIDE OF THE INFUSION THE IV TUBING WAS CLAMPED WHILE PUSHING MEDICATION AND GAVE AN ERROR OF DISTAL PRESSURE SENSOR E342.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1857433 PLUM 360¿ INFUSER PUMP, INFUSION FRN ICU MEDICAL COSTA RICA LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Death UNSPECIFIED MEDICATION, MFR UNK.| UNSPECIFIED TUBING SET, MFR UNK.