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

Model Number	36010
Medical Device Problem Code	Battery Problem (2885)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a spectrum v9 wireless battery had a dead battery during an unspecified process step.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
D4: unique identifier (udi) #: the serial number (21) is unknown, therefore, the udi number only will contain the device identifier (01).The device was not returned and the serial number is unknown; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

• 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: 23482225
• Report Number: 1314492-2025-02841
• Device Sequence Number: 10252470
• Product Code: FRN
• UDI-Device Identifier: 00085412718378
• UDI-Public: (01)00085412718378
• Combination Product (Y/N): N
• Initial Reporter State: PA
• Initial Reporter Country: US
• PMA/510(K) Number: NI
• 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): 11/05/2025

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: 36010
• Device Catalogue Number: 36010
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 10/08/2025
• Initial Report FDA Received Date: 11/05/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: ASKU
• Patient Sex: Unknown