MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION SPECTRUM WIRELESS BATTERY MODULE

Catalog Number	36010
Medical Device Problem Code	Failure to Run on Battery (1466)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/08/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received for evaluation.During functional testing, the reported problem "stopped pumping and the screen flickered white" was not reproduced.A service history review revealed no indication that the parts replaced during servicing caused or contributed to the reported event.The reported condition was verified.The cause of the condition was the fluid intrusion to the battery contacts causing corrosion.The wireless battery module was unable to be tested due to the corroded contacts.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that a v9 wireless battery module failed during use without a notification.This was further described as "the pump stopped pumping and the screen flickered white".This occurred during patient infusion in the intensive care unit.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

• Brand Name: SPECTRUM WIRELESS BATTERY MODULE
• Common Device Name: WIRELESS BATTERY MODULE
• 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 ; 2242705355
• MDR Report Key: 24821571
• Report Number: 1314492-2026-00733
• Device Sequence Number: 9601119
• Product Code: FRN
• UDI-Device Identifier: 00085412718378
• UDI-Public: (01)00085412718378
• Combination Product (Y/N): N
• Initial Reporter State: CA
• Initial Reporter Country: US
• PMA/510(K) Number: K222048
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial
• Report Date (Section B): 04/08/2026

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 Catalogue Number: 36010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/23/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/12/2026
• Initial Report FDA Received Date: 04/08/2026
• 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
• Concomitant Medical Products and Therapy/Usage Dates: SPECTRUM IQ PUMP SN (B)(6).
• Patient Sex: Unknown