FDA Adverse Event Malfunction Summary report: N

PUMP, INFUSION

MDR report key: 22833976 · Received August 18, 2025

Report

Report Number
MW5174861
Event Type
Malfunction
Date Received
August 18, 2025
Date of Event
July 31, 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 (B)(6) 2025, THE HEALTHCARE TECHNOLOGY MANAGEMENT (HTM) TEAM RECEIVED 217 UNSCHEDULED WORK ORDERS RELATED TO PLUM 360 INTRA VENOUS 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. HEALTH CODE: 4582. DEVICE CODES: 2885; 1420; 1057; 1466. OVER THE COURSE OF THE MONTH OF JULY 2025, THE HEALTHCARE TECHNOLOGY MANAGEMENT (HTM) TEAM RECEIVED 217 UNSCHEDULED WORK ORDERS RELATED TO PLUM 360 INTRA VENOUS 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. HEALTH CODE: 4582. DEVICE CODES: 2885; 1420; 1057; 1466. REFERENCE REPORTS: MW5174666, MW5174667, MW5174668, MW5174669, MW5174670, MW5174671, MW5174672, MW5174673, MW5174674, MW5174675, MW5174676, MW5174677, MW5174678, MW5174679, MW5174680, MW5174681, MW5174682, MW5174683, MW5174684, MW5174685, MW5174686, MW5174687, MW5174688, MW5174689, MW5174690, MW5174691, MW5174692, MW5174693, MW5174694, MW5174695, MW5174696, MW5174697, MW5174698, MW5174699, MW5174700, MW5174701, MW5174702, MW5174703, MW5174704, MW5174705, MW5174706, MW5174707, MW5174708, MW5174709, MW5174710, MW5174711, MW5174712, MW5174713, MW5174714, MW5174715, MW5174716, MW5174717, MW5174718, MW5174719, MW5174720, MW5174721, MW5174722, MW5174723, MW5174724, MW5174725, MW5174726, MW5174727, MW5174728, MW5174729, MW5174730, MW5174731, MW5174732, MW5174733, MW5174734, MW5174735, MW5174736, MW5174737, MW5174738, MW5174739, MW5174740, MW5174741, MW5174742, MW5174743, MW5174744, MW5174745, MW5174746, MW5174747, MW5174748, MW5174749, MW5174750, MW5174751, MW5174752, MW5174753, MW5174754, MW5174755, MW5174756, MW5174757, MW5174758, MW5174759, MW5174760, MW5174761, MW5174762, MW5174763, MW5174764, MW5174765, MW5174766, MW5174767, MW5174768, MW5174769, MW5174770, MW5174771, MW5174772, MW5174773, MW5174774, MW5174775, MW5174776, MW5174777, MW5174778, MW5174779, MW5174780, MW5174781, MW5174782, MW5174783, MW5174784, MW5174785, MW5174786, MW5174787, MW5174788, MW5174789, MW5174790, MW5174791, MW5174792, MW5174793, MW5174794, MW5174795, MW5174796, MW5174797, MW5174798, MW5174899, MW5174800, MW5174801, MW5174803, MW5174804, MW5174805, MW5174806, MW5174807, MW5174808, MW5174809, MW5174810, MW5174811, MW5174812, MW5174813, MW5174814, MW5174815, MW5174816, MW5174817, MW5174818, MW5174819, MW5174820, MW5174821, MW5174822, MW5174823, MW5174824, MW5174825, MW5174826, MW5174827, MW5174828, MW5174829, MW5174830, MW5174831, MW5174832, MW5174833, MW5174834, MW5174835, MW5174836, MW5174837, MW5174838, MW5174839, MW5174840, MW5174841, MW5174842, MW5174843, MW5174844, MW5174845, MW5174846, MW5174847, MW5174848, MW5174849, MW5174850, MW5174851, MW5174852, MW5174853, MW5174854, MW5174855, MW5174856, MW5174857, MW5174858, MW5174859, MW5174860, MW5174862, MW5174863, MW5174864, MW5174865, MW5174866, MW5174867, MW5174868, MW5174869, MW5174870, MW5174871, MW5174872, MW5174873, MW5174874, MW5174875, MW5174876, MW5174877, MW5174878, MW5174879, MW5174880, MW5174881, MW5174882 AND MW5174883.

Devices

Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
1974318 PUMP, INFUSION PUMP, INFUSION FRN ICU MEDICAL, INC.

Patients

Seq Age Sex Outcome Treatment
1 NA Unknown Other