BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    UNSPECIFIED PLUM 360 PUMP

    MDR report key: 16626875 · Received March 28, 2023

    Report

    Report Number
    9615050-2023-00087
    Event Type
    Malfunction
    Date Received
    March 28, 2023
    Date of Event
    December 20, 2022
    Report Date
    March 20, 2023
    Manufacturer
    ICU MEDICAL COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    UNKNOWN
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS NOT RECEIVED BY THE MANUFACTURER. THE SOFTWARE ENGINEERING TEAM HAS REVIEWED THE COMPLAINT DETAILS & LOGS. R&D ENGINEERING WORKED WITH TECHNICAL SUPPORT TO INVESTIGATE BY RUNNING SQL QUERIES TO IDENTIFY THE PUMP THAT WAS THE SOURCE OF THE REPORTED LIMIT ALERTS AND THEN HAVING MEDNET EVENT/ALARM LOG (EAL) RUN FOR THAT DEVICE TO IDENTIFY THE EVENTS SURROUNDING THE INCIDENT. ALL FOUR REPORTED LIMIT ALERTS WERE FOUND TO COME FROM THE SAME DEVICE: PLUM 15.20.01.018 SERIAL # (B)(6). ENGINEERING RESEARCHED AND FOUND THAT THIS IS A KNOWN CATEGORY OF ISSUE WITH THE PLUM 15 PUMPS COMMUNICATING CLINICAL SIGNALS TO MEDNET OVER HDP PROTOCOL IN WHICH, ON A CANCELLED INFUSION OR TITRATION (AS IN THIS CASE), THE PUMP DOES NOT CORRECTLY UPDATE THE INFUSION SEGMENT. WHEN THE USER CANCELS AN INFUSION (OR CANCELS AN ATTEMPTED TITRATION LIKE THE ATTEMPT IN THIS CASE TO TITRATE TO 99 ML/HR EXCEEDING THE UPPER HARD LIMIT (UHL) OF 84), THEY DO NOT INCREMENT THE INFUSION SEGMENT. IT IS LIKE IT NEVER EXISTED; THEN WHEN THE OTHER LIMIT VIOLATION IN THE BOLUS OCCURRED (IN THIS CASE ATTEMPTING A BOLUS VOLUME OF 9 ML EXCEEDING THE UHL OF 5 ML) THE HDP PROTOCOL CLINICAL SIGNAL LACKS A REFERENCE TO THE INFUSION SEGMENT SO MEDNET DOESN¿T KNOW IT¿S A DIFFERENT INFUSION SEGMENT; THEN WHEN THE USER CANCELS THAT BOLUS ATTEMPT (OF 9 ML) AND ACTUALLY PROGRAMS THE BOLUS WITH A RATE OF 999 ML/HR (ALLOWED FOR A BOLUS); MEDNET STILL LACKS INFORMATION TO KNOW THIS IS A DIFFERENT SEGMENT FROM THE CANCELLED TITRATION, ONLY THAT THERE WAS AN UHL ALERT ON THE RATE AND A RATE OF (B)(4) WAS FINALLY ADOPTED. ENGINEERING EVALUATES THIS IS A PLUM 360 ISSUE, DOCUMENTED UNDER SCR PLUM LCM-20960. ENGINEERING REPORTS ATTEMPTS WERE MADE TO FIND WAYS FOR MEDNET, AS A WORKAROUND, TO ACCURATELY INFER, FROM THE DATA AVAILABLE IN THE EXISTING CLINICAL HDP SIGNALS, THE PRESENCE OF THE NEW INFUSION SEGMENT SO TO AS TO DEPICT IN THE MEDNET EVD REPORT THE CORRECT EVENTS THAT OCCURRED ON THE DEVICE. AT THIS TIME, NO SUCH WORKAROUND HAS BEEN FOUND FEASIBLE. THIS NEED IS DOCUMENTED BY SCR HMSS-19227.

    Additional Manufacturer Narrative · 0

    THE DEVICE IS NOT AVAILABLE FOR INVESTIGATION. WITHOUT THE RETURN OF THE DEVICE A PROBABLE CAUSE IS UNABLE TO BE DETERMINED.

    Description of Event or Problem · 0

    THE EVENT INVOLVED A PLUM 360 15.20 INFUSION PUMP. THE CUSTOMER REPORTED THAT REPORTS FROM MEDNET SHOW THAT THE FINAL DOSE OF PROPOFOL PERF WAS HIGHER THAN THE PROGRAMMED UPPER HARD LIMIT (UHL). THE CUSTOMER DISCOVERED THIS ISSUE WHILE RUNNING A DATA ANALYSIS. THESE ARE CLINICAL REPORTS AND THERE IS NO WAY TO FIND THE DEVICE. THERE WAS UNKNOWN PATIENT INVOLVEMENT, AND NO HARM WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    27676 UNSPECIFIED PLUM 360 PUMP PUMP, INFUSION FRN ICU MEDICAL COSTA RICA LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown PROPOFOL, 1000MG/100ML, MFR UNK