BEUDAMED
    FDA Adverse Event Other Summary report: N

    PUMP, INFUSION

    MDR report key: 22853393 · Received August 20, 2025

    Report

    Report Number
    MW5175019
    Event Type
    Other
    Date Received
    August 20, 2025
    Date of Event
    June 30, 2025
    Report Date
    August 12, 2025
    Manufacturer
    ICU MEDICAL, INC.
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    WV, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    Yes

    Narratives

    Description of Event or Problem · 0

    OVER THE COURSE OF THE MONTH OF JUNE 2025, THE HEALTHCARE TECHNOLOGY MANAGEMENT (HTM) TEAM RECEIVED 165 UNSCHEDULED WORK ORDERS RELATED TO PLUM 360 INTRAVENOUS INFUSION PUMPS UTILIZING THE VISION BATTERY. THE BATTERY ISSUES VARIED FROM ERROR MESSAGES INDICATING "SERVICE BATTERY", "BATTERY NOT INSTALLED". THESE PUMPS WERE PURCHASED IN THE SPRING OF 2024 AND PUT INTO USE IN THE FALL OF 2024. IMPLEMENTATION WAS DELAYED UNTIL AFTER ICU MEDICAL ADDRESSED A RECALL ON THE PREVIOUSLY USED CSB BATTERIES. ICU MEDICAL REPLACED ALL CSB BATTERIES WITH VISION BATTERIES AND THE HEALTH CARE SYSTEM BEGAN USING THE PUMPS WITH THE REPLACEMENT BATTERIES IN THE FALL OF 2024. ACCORDING TO ICU MEDICAL, THE VISION BATTERY SHOULD HAVE A LIFESPAN OF 1-2 YEARS. CURRENTLY, THE LIFE SPAN IS LESS THAN 8 MONTHS. ICU MEDICAL HAS BEEN ALERTED TO THESE CONCERNS AND OFFICIAL COMPLAINTS FILED WITH THE VENDOR. AS OF THIS REPORT, BATTERIES HAVE BEEN RETURNED TO ICU MEDICAL. ICU MEDICAL IS WORKING ON REPLACING THE FLEET OF BATTERIES IN THE UPCOMING WEEKS OF AUGUST 2025. HOWEVER, THE HOSPITAL CONTINUES TO EXPERIENCE A SIGNIFICANT FAILURE RATE OF THESE BATTERIES WHICH IS POSING A SIGNIFICANT THREAT TO PATIENT CARE. PATIENT CODE: 4582. DEVICE CODE: 1057; 1420; 1466; 2885. REFERENCE REPORTS: MW5174884, MW5174885, MW5174886, MW5174887, MW5174888, MW5174889, MW5174890, MW5174891, MW5174892, MW5174893, MW5174894, MW5174895, MW5174896, MW5174897 MW5174898, MW5174899, MW5174900, MW5174901, MW5174902, MW5174903, MW5174904, MW5174905, MW5174906, MW5174907, MW5174908, MW5174909, MW5174910, MW5174911, MW5174912, MW5174913, MW5174914, MW5174915, MW5174916, MW5174917, MW5174918, MW5174919, MW5174920, MW5174921, MW5174922, MW5174923, MW5174924, MW5174925, MW5174926, MW5174927, MW5174928, MW5174929, MW5174930, MW5174931, MW5174932, MW5174933, MW5174934, MW5174935, MW5174936, MW5174937, MW5174938, MW5174939, MW5174940, MW5174941, MW5174942, MW5174943, MW5174944, MW5174945, MW5174946, MW5174947, MW5174948, MW5174949, MW5174950, MW5174951, MW5174952, MW5174953, MW5174954, MW5174955, MW5174956, MW5174957, MW5174958, MW5174959, MW5174960, MW5174961, MW5174962, MW5174963, MW5174964, MW5174965, MW5174966, MW5174967, MW5174968, MW5174969, MW5174970, MW5174971, MW5174972, MW5174973, MW5174974, MW5174975, MW5174976, MW5174977, MW5174978, MW5174979, MW5174980, MW5174981, MW5174982, MW5174983, MW5174984, MW5174985, MW5174986, MW5174987, MW5174988, MW5174989, MW5174990, MW5174991, MW5174992, MW5174993, MW5174994, MW5174995, MW5174996, MW5174997, MW5174998, MW5174999, MW5175000, MW5175001, MW5175002, MW5175003, MW5175004, MW5175005, MW5175006, MW5175007, MW5175008, MW5175009, MW5175010, MW5175011, MW5175012, MW5175013, MW5175014, MW5175015, MW5175016, MW5175017, MW5175018, MW5175020, MW5175021, MW5175022, MW5175023, MW5175024, MW5175025, MW5175026, MW5175027, MW5175028, MW5175029, MW5175030, MW5175031, MW5175032, MW5175033, MW5175034, MW5175035, MW5175036, MW5175037, MW5175038, MW5175039, MW5175040, MW5175041, MW5175042, MW5175043, MW5175044, MW5175045, MW5175046, MW5175047, MW5175048.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    418377 PUMP, INFUSION PUMP, INFUSION FRN ICU MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other