MAUDE Adverse Event Report: BAXTER INTERNATIONAL INC. SPECTRUM WIRELESS BATTERY MODULE

Model Number	36010
Medical Device Problem Code	Failure to Run on Battery (1466)
Health Effect - Clinical Code	Low Blood Pressure/ Hypotension (1914)
Date of Event	04/21/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: initial reporter phone no.(b)(6).Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that a spectrum wireless battery module was connected to a pump which shut off unexpectedly during norepinephrine therapy in the intensive care unit.As a result the pump had to be replaced and during this time the patient became hypotensive.No additional information is available.
Additional Manufacturer Narrative
Correction: b1, b2, d1: brand name, d3: device manufacturer name, d4: model #, d4: unique identifier (udi) #, g4: combination product, h1: type of reportable event.Additional information d9, h3, h6 and h11: h11: the device was received for evaluation.During functional testing, pump shut off unexpectedly was not reproduced.A review of the event history log revealed that on the customer reported event date of april 21, 2023, the user programmed and infusion of "norepinephrine 4 mg/250 ml" in the "2.Criticalcare adult" care area.The history log revealed that a "battery alert!" presented and was confirmed by the user.The pump was unplugged and continued, however 2 hours and 22 minutes after the alert, the user experienced an "improper shutdown!" message at power up of the device, indicating that all power sources to the pump were lost.Per the history log review, a "battery alert!" occurred during programming of the infusion.A battery alert presents on the pump display with the following instruction: "¿battery error do not unplug pump! battery operation may not be available.¿ removing the power cord could result in an shutdown of the device due to lack of available battery power.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 cause of the condition was determined to be corroded battery contacts.The battery module will not be serviced.Based on additional information received v9 wireless battery was determind not to be a factor in the reported adverse event.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: SPECTRUM WIRELESS BATTERY MODULE
• Common Device Name: WIRELESS BATTERY MODULE
• Manufacturer (Section D): BAXTER INTERNATIONAL INC.; 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: 18759648
• Report Number: 1314492-2024-00457
• Device Sequence Number: 12339570
• Product Code: FRN
• UDI-Device Identifier: 00085412718378
• UDI-Public: (01)00085412718378
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K133801
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 07/22/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 36010
• Device Catalogue Number: 36010
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/29/2024
• Supplement Date Received by Manufacturer: 07/17/2024
• Initial Report FDA Received Date: 02/22/2024
• Supplement Report FDA Received Date: 07/22/2024
• 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: NOREPINEPHRINE; SPECTRUM PUMP SN (B)(6)
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown