BEUDAMED
    FDA Adverse Event Other Summary report: N

    PUMP, INFUSION

    MDR report key: 22698602 · Received August 4, 2025

    Report

    Report Number
    MW5173833
    Event Type
    Other
    Date Received
    August 4, 2025
    Date of Event
    May 31, 2025
    Report Date
    July 25, 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 MAY 2025, THE HEALTHCARE TECHNOLOGY MANAGEMENT (HTM) TEAM RECEIVED 160 UNSCHEDULED WORK ORDERS RELATED TO PLUM 360 IV INFUSION PUMPS UTILIZING THE VISION BATTERY PROBLEMS, WHICH WERE PURCHASED FROM ICU MEDICAL. 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 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, ARRANGEMENTS ARE PENDING FOR PICK-UP OF THE BATTERIES FOR EVALUATION BY ICU MEDICAL. DEVICE CODE: 1466. PATIENT CODE: 4582. REFERENCE REPORTS: MW5173830, MW5173831, MW5173832, MW5173834, MW5173835, MW5173836, MW5173837, MW5173838, MW5173839, MW5173840, MW5173841, MW5173842, MW5173843, MW5173844, MW5173845, MW5173846, MW5173847, MW5173848, MW5173849, MW5173850, MW5173851, MW5173852, MW5173853, MW5173854, MW5173855, MW5173856, MW5173857, MW5173858, MW5173859, MW5173860, MW5173861, MW5173862, MW5173863, MW5173864, MW5173865, MW5173866, MW5173867, MW5173868, MW5173869, MW5173870, MW5173871, MW5173872, MW5173873, MW5173874, MW5173875, MW5173876, MW5173877, MW5173878, MW5173879, MW5173880, MW5173881, MW5173882, MW5173883, MW5173884, MW5173885, MW5173886, MW5173887, MW5173888, MW5173889, MW5173890, MW5173891, MW5173892, MW5173893, MW5173894, MW5173895, MW5173896, MW5173897, MW5173898, MW5173899, MW5173900, MW5173901, MW5173902, MW5173903, MW5173904, MW5173905, MW5173906, MW5173907, MW5173908, MW5173909, MW5173910, MW5173911, MW5173912, MW5173913, MW5173914, MW5173915, MW5173916, MW5173917, MW5173918, MW5173919, MW5173920, MW5173921, MW5173922, MW5173923, MW5173924, MW5173925, MW5173926, MW5173927, MW5173928, MW5173929, MW5173930, MW5173931, MW5173932, MW5173933, MW5173934, MW5173935, MW5173936, MW5173937, MW5173938, MW5173939, MW5173940, MW5173941, MW5173942, MW5173943, MW5173944, MW5173945, MW5173946, MW5173947, MW5173948, MW5173949, MW5173950, MW5173951, MW5173952, MW5173953, MW5173954, MW5173955, MW5173956, MW5173957, MW5173958, MW5173959, MW5173960, MW5173961, MW5173962, MW5173963, MW5173964, MW5173965, MW5173966, MW5173967, MW5173968, MW5173969, MW5173970, MW5173971, MW5173972, MW5173973, MW5173974, MW5173975, MW5173976, MW5173977, MW5173978, MW5173979, MW5173980, MW5173981, MW5173982, MW5173983, MW5173984, MW5173985, MW5173986, MW5173987, MW5173988, MW5174017.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    2635682 PUMP, INFUSION PUMP, INFUSION FRN ICU MEDICAL, INC.

    Patients

    Seq Age Sex Outcome Treatment
    1 NA Unknown Other