BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    PLUM A+ WIRELESS PUMP NEW SPANISH 110V

    MDR report key: 16311757 · Received February 7, 2023

    Report

    Report Number
    9615050-2023-00026
    Event Type
    Malfunction
    Date Received
    February 7, 2023
    Date of Event
    January 18, 2023
    Report Date
    January 19, 2023
    Manufacturer
    ICU MEDICAL COSTA RICA LTD.
    Product Code
    FRN
    PMA / PMN Number
    K042081
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO
    Reporter Occupation
    BIOMEDICAL ENGINEER
    Health Professional
    Yes

    Narratives

    Additional Manufacturer Narrative · 0

    THE DEVICE WAS PROGRAMMED IN CHANNEL A IN 5 MULTI-STEPS TO DELIVER A TOTAL VOLUME OF 682 ML IN 2 HOURS 30 MINUTES, OBTAINING AS A RESULT 686 ML DELIVERED IN 2 HOURS 29 MINUTES. 682 ML *5% = (+/- 34 ML) WITH A TOLERANCE OF +/- 5%, THE DELIVERY VALUE WAS FOUND IN THE ALLOWED RANGE. THE DELIVERY MARGIN OF ERROR WAS + 4 ML. ACCORDING TO THE CUSTOMER'S EXPERIENCE, THE DEVICE DID NOT DELIVER THE MEDICATION. BUT THE CUSTOMER'S PROTOCOL TESTS DETERMINED THAT THE DEVICE WORKS FOR 2 HOURS 29 MINUTES WITHOUT INTERRUPTION AND IS IN BATTERY MODE AFTER BEING CHARGED. THE INFUSION WAS COMPLETED WITHOUT LOW DELIVERIES OR VALUE ALTERATIONS. A KEYBOARD TEST WAS CARRIED OUT TO VERIFY THAT IT DID NOT AUTO-PROGRAM. EACH KEY WORKS CORRECTLY, THE TEST PASSED CORRECTLY. BATTERY ALARMS WERE NOT RELEVANT TO THE INVESTIGATION. BECAUSE THE INITIAL CAUSE WAS A PROGRAMMING ERROR, HOWEVER, THE BATTERY WILL BE REPLACED IN THE REPAIR PROCESS. PROBABLE CAUSE: THE USER DID NOT PROGRAM THE DOSE IN MG/HR BUT IN MCG/MIN. USER ERROR IN PROGRAMMING. INITIAL REPORTER PHONE: (B)(6).

    Description of Event or Problem · 0

    IT WAS REPORTED THAT A PLUM A+ PUMP WAS PROGRAMMED WITH ONCOLOGICAL MEDICATION AND AT THE END OF THE INFUSION TIME, THE TOTALITY OF THE MEDICATION WAS FOUND WITHOUT BEING INFUSED. THE PUMP WAS CHECKED, AND IT WAS OBSERVED THAT IT WAS INFUSING BUT WITHOUT ANY EVIDENT DRIPPING. THE MEDICATION, FLOW, AND CONCENTRATION PROGRAMMED WAS RITUXIMAB 532MG IN 500CC OF SALINE SOLUTION 0. 9% 100MG/H (TITRATABLE ACIDITY) UP TO 400MG/H (RR RITUXIMAB 500MG/50ML INJECTABLE SOLUTION X 50ML, 1 AMPOULE WAS USED) AND (RR RITUXIMAB 100MG/10ML INJECTABLE SOLUTION X 10ML, 1 AMPOULE WAS USED). TITRATABLE ACIDITY IN STEPS MG/H, EVERY 30 MIN FROM 50 3N 50. AT 02:30 PM THE RITUXIMAB INFUSION WAS REPROGRAMMED. ONE VIDEO SHOWING THE ISSUE WITH ALERTS TO CHANGE THE BATTERY AND N161 CHANNEL A VOLUME TO BE INFUSED (VTBI) COMPLETE AND ONE PICTURE SHOWING THE PRODUCT LABEL WERE PROVIDED. BECAUSE OF THIS EVENT, THE ONCOLOGICAL THERAPY WAS NOT PERFORMED TO THE PATIENT AND THERE WAS A DELAY IN THE HEALTH CARE THERAPY; HOWEVER, NO ONE WAS REPORTED HARMED AS A RESULT OF THIS EVENT. THERE WAS NO PATIENT HARM REPORTED. NO ADDITIONAL INFORMATION IS AVAILABLE AT THIS TIME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    81385 PLUM A+ WIRELESS PUMP NEW SPANISH 110V PUMP, INFUSION FRN ICU MEDICAL COSTA RICA LTD.

    Patients

    Seq Age Sex Outcome Treatment
    1 56 YR Female RITUXIMAB, UKN MFR