BEUDAMED
    FDA Adverse Event Injury Summary report: N

    POMPE PLUM 360¿, FRANÇAIS CANADIEN, COMPATIBLE AVEC LE LOGICIEL ICU MEDICAL MEDN

    MDR report key: 15077092 · Received July 21, 2022

    Report

    Report Number
    9615050-2022-00155
    Event Type
    Injury
    Date Received
    July 21, 2022
    Date of Event
    July 5, 2022
    Report Date
    July 13, 2022
    Manufacturer
    ICU MEDICAL COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K161469
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    ALTHOUGH THE DEVICE WAS REQUESTED TO BE RETURNED FOR EVALUATION, IT HAS NOT BEEN RECEIVED. INVESTIGATION IS PENDING

    Additional Manufacturer Narrative · 0

    COMPLAINT OF " CASSETTE TEST FAILURE" WAS SEEN IN HISTORY LOG ONLY WITH N251 BUT WAS NOT DUPLICATED DURING TESTING. HISTORY LOGS WERE DOWNLOADED FROM THE DEVICE. ICU MEDICAL REACHED OUT TO THE CUSTOMER AND STATED THAT THIS PUMP WAS INSTALLED IN THE FALL OF 2021 AND IS STILL UNDER WARRANTY, NO REPAIRS OR MAINTENANCE HAVE BEEN REQUIRED OR PERFORMED ON THIS PUMP. THEREFORE, A SERVICE/REPAIR HISTORY IS NOT AVAILABLE. BASED ON INFORMATION FROM THE MANUFACTURING PLANT, THE EDHR OF THE SERIAL NUMBER (B)(6) DO NOT SHOWS ANY CONDITION DURING THE MANUFACTURING PROCESS. ALL MECHANISM TESTS AND DELIVERY TESTS ARE CORRECT AND THE DEVICE HAS NO REPAIRS. BROKEN COVER LEVER FOUND . STRESS TEST WAS PERFORMED BASED ON PROCEDURE 588-98633-001, DURING 6 HOURS WITH 250ML/H DELIVERY RATE THE TEST PASSED SUCCESSFULLY WITHOUT ANY ERROR. ADDITIONALLY, THERE IS NO EVIDENCE OF PRODUCT BEING TAMPERED OR COUNTERFEIT. THE LOGS / EVENTS WERE REVIEWED BY THE SOFTWARE ENGINEERING TEAM. THE CUSTOMER¿S REPORTED DIFFICULTIES PROGRAMMING INTRAVENOUS AMIODARONE (¿AFTER SEVERAL ERROR TESTS, IT ALLOWS TO PUT IT AT 400ML/HR¿) WERE DUE TO PROGRAMMING IN CONCURRENT MODE AND CUSTOMER EITHER NOT REALIZING THE LINE A PROGRAM (100 ML/HR), THOUGH NOT ACTIVELY RUNNING, HAD STILL NOT BEEN CANCELED AND/OR NOT REALIZING THE PUMP HAD A CONCURRENT DESIGN LIMIT OF 500 ML/HR COMBINED BETWEEN BOTH LINES. THE PUMP OPERATED CORRECTLY AS PER DESIGN IN LIMITING THE ALLOWED LINE B RATE TO 400 ML/HR. THIS PART OF THE COMPLAINT WAS CONFIRMED. THE PROBABLE CAUSE BEING CUSTOMER MISUNDERSTANDING OF PUMP DESIGN LIMITS. THE CUSTOMER¿S REPORT THAT ¿BUT THEN¿ (I.E. AFTER THE PUMP ALLOWED THE RATE OF 400 ML/HR) ¿REALIZED AFTER 5 MINUTES THAT THE DEVICE HAD NOT STARTED INFUSING¿ IS NOT SUPPORTED BY THE LOGS. THE LOGS RECORD THAT, ONCE THE RATE OF 400 ML/HR WAS ENTERED, THE INFUSION BEGAN DELIVERING WITHIN ABOUT 3 SECONDS. THIS PART OF THE COMPLAINT WAS NOT CONFIRMED. THE CUSTOMER¿S REPORTED FACING OF ¿REPETITIVE CASSETTE TEST FAILURE ALARMS¿ WERE PROBABLY DUE TO AIR BUBBLE PRESENT IN THE CASSETTE FOLLOWING THE PREVIOUS OPENING OF THE CASSETTE DOOR AND NOT BEING CLEARED BEFORE RESEATING THE CASSETTE, AS DESCRIBED IN THE SOM (SYSTEM OPERATING MANUAL). THIS PART OF THE COMPLAINT WAS CONFIRMED. THE PROBABLE CAUSE BEING CUSTOMER MISUNDERSTANDING OF THE MEANING OF THE CASSETTE TEST FAILURE ALARM AND METHOD OF RECOVERING. ENGINEERING EVALUATES THE PUMP OPERATED CORRECTLY WITHIN DESIGN SPECIFICATION. ADDITIONAL CUSTOMER EDUCATION MAY BE NEEDED. DATE RETURNED TO MFG NULL: 7/28/2022.

    Description of Event or Problem · 0

    THE EVENT INVOLVED A PLUM 360 INFUSION PUMP. THE CUSTOMER REPORTED DURING AN EMERGENCY INVOLVING A CODE BLUE WITH A PATIENT, THE SPEED AT WHICH THE PHYSICIAN ORDERED LACTATE RINGER (500ML) IN STAT VIA A CENTRAL WAY TO BE INFUSED COULD NOT BE MET. THE TUBING WAS CHANGED, AND THE DOCTOR THEN ORDERED INTRAVENOUS AMIODARONE. IT WAS AGREED ON A RATE TO BYPASS THE ISSUE, AFTER SEVERAL ERROR TESTS, IT ALLOWED THE PUMP TO SET AT 400ML/H HOWEVER AFTER FIVE MINUTES THE DEVICE DID NOT START INFUSING BEFORE THE STAFF FINALLY LAUNCHED THE INFUSION WHICH ADDED TO THE DELAY. REPETITIVE CASSETTE TEST FAILURE ALARMS OCCURRED, AND THEY POTENTIALLY NEEDED TO USE ANOTHER DEVICE TO COMPLETE THE TREATMENT. THERE WAS PATIENT INVOLVEMENT AND THERE WAS NO FURTHER REPORT OF ADDITIONAL HUMAN HARM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1699449 POMPE PLUM 360¿, FRANÇAIS CANADIEN, COMPATIBLE AVEC LE LOGICIEL ICU MEDICAL MEDN PUMP, INFUSION FRN ICU MEDICAL COSTA RICA LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown Required Intervention| L AMIODARONE, MFR UNK| LACTATE RINGER 500ML, MFR UNK| UNSPECIFIED TUBING SET, MFR UNK