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

Catalog 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 wireless battery module did not work during testing in the biomedical service department.There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
A service history review revealed no indication that the parts replaced during servicing caused or contributed to the reported event.The device was not received for evaluation; therefore, a device analysis could not be completed.The device malfunction red battery screen and does not work does not affect the functionality or efficacy of the device.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: SPECTRUM WIRELESS BATTERY MODULE
• Common Device Name: PUMP, INFUSION
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - MEDINA; 711 park ave; medina NY 14103
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 18472229
• Report Number: 1314492-2024-00022
• Device Sequence Number: 6718798
• Product Code: FRN
• UDI-Device Identifier: 00085412718378
• UDI-Public: (01)00085412718378
• Combination Product (Y/N): N
• Initial Reporter State: AR
• 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): N
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 03/06/2024

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
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 12/14/2023
• Supplement Date Received by Manufacturer: 03/01/2024
• Initial Report FDA Received Date: 01/08/2024
• Supplement Report FDA Received Date: 03/06/2024
• 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