MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION WIRELESS BATTERY MODULE; PUMP, INFUSION

Model Number	35223
Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	07/13/2025
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The serious injury event of cardiac arrest/"patient coded" was reported under mdr report number 1314492-2025-02037 for the pump.This mdr is for the battery within this spectrum iq pump.The device was received for evaluation.During functional testing, the reported issue of "pump shut off by itself" was not reproduced.External inspection found no damage to the front case or rear case.Internal inspection found no damage inside the front case and none inside the rear case.Internal inspection found the contacts of the wireless battery module (wbm) with corrosion.The multimeter test had failed results revealing cell imbalance in the battery pack.The wbm was able to charge when put on a known good pump.A service history review was performed and revealed that the device has no previous service events; therefore, servicing did not cause or contribute to the reported event.The reported condition was verified.The direct cause of the customer reported issue of "pump shut off by itself" was undetermined.The probable cause would be cell imbalance in the battery pack and corrosion on the contacts however, the wbm was determined to be unserviceable.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that a wireless battery module shut off by itself during patient infusion in the emergency department.This pump was left plugged in and delivering medicine on a patient in a room.Staff noticed the iv pump to be off.It did not alarm infusion complete or anything else- it was just off.Nurse then turned the pump back on and saw an ¿improper shutdown message".There was no report of patient injury or medical intervention associated with this event.No additional information is available.

• Brand Name: WIRELESS BATTERY MODULE
• Common Device Name: PUMP, INFUSION
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - MEDINA; 711 park avenue; medina NY 14103
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 22796721
• Report Number: 1314492-2025-02039
• Device Sequence Number: 12840774
• Product Code: FRN
• UDI-Device Identifier: 00085412718378
• UDI-Public: (01)00085412718378
• Combination Product (Y/N): N
• Initial Reporter State: NJ
• Initial Reporter Country: US
• PMA/510(K) Number: K173084
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 08/13/2025

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 35223
• Device Catalogue Number: 35223
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/23/2025
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/14/2025
• Initial Report FDA Received Date: 08/13/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Reuse
• Patient Sequence Number: 1
• Patient Sex: Unknown