BEUDAMED
    FDA Adverse Event Injury Summary report: N

    PLUM 360¿ INFUSER

    MDR report key: 22749594 · Received August 8, 2025

    Report

    Report Number
    9615050-2025-00378
    Event Type
    Injury
    Date Received
    August 8, 2025
    Date of Event
    July 9, 2025
    Report Date
    January 14, 2026
    Manufacturer
    ICU MEDICAL COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K161469
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ANALYSIS: THE RELATED COMPLAINT OF OVER-DELIVERED/OVER-INFUSED THE MEDICATION/ CASSETTE FAILURE WAS INVESTIGATED WITH INFORMATION AVAILABLE, WHERE NO DEVICE WAS RETURNED TO THE SERVICE HUB FOR ANALYSIS AND EVALUATION. THEREFORE, NO VISUAL INSPECTION AND FUNCTIONAL TESTING COULD BE PERFORMED TO DETERMINE IF THE DEVICE PLAYED A ROLE IN THE ADVERSE EVENT. A 12-MONTH REVIEW WAS CONDUCTED, AND NO SIMILAR EVENTS WERE FOUND TO OCCUR IN THE PAST. GCM REACHED OUT TO THE CUSTOMER FOR THE SERVICE REPAIR HISTORY WHICH SHOWED SEVERAL REPAIR EVENTS, NONE OF WHICH WERE RELATED TO THIS EVENT. EVENT LOGS WERE PROVIDED AND ANALYZED BY R&D, SEE CONCLUSION BELOW AND ATTACHMENTS FOR FURTHER DETAL. ENGINEERING CONCLUSION: ENGINEERING CANNOT DETERMINE THE PHYSICAL START/END VOLUME OF THE BAG BASED ON THE LOGS AND CANNOT CONFIRM THE CUSTOMER'S COMPLAINT OF OVER INFUSING AND FINISHING IN 1 HOURS VS. THE PROGRAMMED 16:40:00HRS. THE PUMP INFUSED CORRECTLY DURING THE 9 MINUTES OF INFUSION WITH THE SPECIFIC PARAMETERS. CONCLUSION: IN CONCLUSION, SINCE THE DEVICE WAS NOT RETURNED TO THE SERVICE HUB FOR ANALYSIS AND EVALUATION, NO VISUAL INSPECTION AND FUNCTIONAL TESTING COULD BE PERFORMED TO DETERMINE IF THE DEVICE HAD A ROLE IN THE ADVERSE EVENT. CTOVAR 14-OCT-2025. THE PLUM 360 PUMP SN (B)(6) THAT WAS SHIPPED TO ECRI WAS SIGNIFICANTLY DAMAGED DUE TO HIGH IMPACT. EVIDENCE INDICATES THAT THE PUMP WAS UPSIDE DOWN AND SUBJECTED TO A SIGNIFICANT DOWNWARD IMPACT FORCE (E.G., A DROP). THIS IMPACT RESULTED IN SEVERAL BROKEN COMPONENTS AND A DISLODGED INLET VALVE SPRING, WHICH CAUSED OVER-DELIVERY AND FREE FLOW.

    Additional Manufacturer Narrative · 0

    CORRECTED INFORMATION IN G3. ADDITIONAL INFORMATION IN B1, B2, B3, B5, B6 D1, D4, E1, H1, AND H6.

    Additional Manufacturer Narrative · 0

    THE COMPLAINT RECORD INDICATES THAT THE DEVICE IS NOT AVAILABLE FOR INVESTIGATION. 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

    ADDITIONAL INFORMATION RECEIVED ON AUGUST 1, 2025 AND AUGUST 20, 2025 FROM THE CUSTOMER STATING THE CLINICIAN NOTICED THE MEDICATION BAG WAS EMPTY. THE PUMP INFUSED A 250 ML BAG OVER ONE HOUR, HOWEVER, WAS PROGRAMMED FOR 15 ML / HOUR. ASSUMPTION BY CLINICIAN IS THE PUMP OVER-INFUSED THE MEDICATION TO THE PATIENT. ADDITIONAL INFORMATION RECEIVED ON 1/14/2026 STATING: DETAILS OF THE EVENT: ON (B)(6) 2025 THE PUMP WAS RUNNING 2000MG OF LIDOCAINE AT 15ML/HR, WITH A STARTING BAG VOLUME OF 250ML, WHEN THE PATIENT EXPERIENCED CHANGES IN MENTATION. THE NURSE PUT THE PUMP ON STANDBY AT 5:56, AND THE PATIENT SEIZED AND STOPPED BREATHING SPONTANEOUSLY. THE PATIENT CODED BUT WAS RESUSCITATED. BASED ON THE TIME ELAPSED, ONLY 90ML SHOULD HAVE BEEN INFUSED; HOWEVER, THE BAG WAS EMPTY EVEN THOUGH THE PUMP WAS ON STANDBY. THIS WAS NOTICED AFTER THE PATIENT CODED. PATIENT IMPACT: A CODE BLUE WAS INITIATED FOR THE PATIENT AT 6:01 AND ENDED AT 6:11. A LIDOCAINE TOXICITY LAB WAS PERFORMED AND FOUND SIGNIFICANTLY ELEVATED LEVELS OF THE MEDICATION IN THE PATIENT. ON (B)(6) 2025, THE PATIENT EXPIRED.

    Description of Event or Problem · 0

    AN UNSPECIFIED PLUM 360 INFUSION PUMP (BASE LIST NO: 30010) THAT REPORTEDLY OVER-DELIVERED/OVER-INFUSED LIDOCAINE; THE BAG COMPLETELY EMPTIED IN 1 HOUR INSTEAD OF THE INTENDED INFUSION TIME. THERE WAS NO HARM REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2065770 PLUM 360¿ INFUSER PUMP, INFUSION FRN ICU MEDICAL COSTA RICA LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown LIDOCAINE, MFR UNK.