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

Model Number	36010
Medical Device Problem Code	Pumping Stopped (1503)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	08/26/2024
Type of Reportable Event	Death
Additional Manufacturer Narrative
This event is related to mfr report number 1314492-2024-03090.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported a spectrum pump stopped infusing and "died" without alarming a low battery.During transport from the intensive care unit to computed tomography (ct) scan, the patient was receiving epinephrine (dose, programmed volume and delivery rate unknown) and lactated ringers via a second spectrum pump.While en route the pump ¿stopped working¿ and the staff was unaware of this stoppage and ¿it¿s possible (that the) notice was given that the battery was failing but due to the stress of the situation someone could have ignored the alarm¿.At this point the pump had been in use for ¿two plus hours¿.Doses of epinephrine were ¿pushed¿, and a new pump was programed to continue the infusion.After an unspecified amount of time the patient died.It was not reported what was the cause of death nor was it reported if an autopsy had been requested.No further information was available at the time of this report.
Additional Manufacturer Narrative
Additional information b1, b2, b3, d9, h3, h6 and h11: h11: the device was received for evaluation.During functional testing, the reported "stopped infusing and "died" at the same time without alarming a low battery" was not reproduced.The wireless battery module was put on a known good pump and began charging.Verified internal software, internal mac address and connected to the network.The event history log (ehl) review was not performed because only the battery was returned for service and the ehl is not retrievable from the battery module.This device has no previous service events; therefore, a service history review is not required, and a review of the device history record was performed.The device history record (dhr) review did not identify any issues during the manufacturing of the device that may be related to the current complaint.Additionally, the review of the dhr did not reveal any evidence of nonconforming product.Evaluation determined the causality to be corroded radio printed circuit board (pcb) contacts from fluid intrusion and therefore the wireless battery module was deemed unserviceable and will be scrapped.The territory manager provided additional information that customer used poor cleaning practices by cleaning the pump without removing the battery from the pump and facility changed cleaning.The territory manager helped with updating the cleaning procedure.The poor cleaning caused the pump to shut down and depressed battery contact pins.Fa-2020-012 addresses the relationship between the poor cleaning practices and pump shut down.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: 20369599
• Report Number: 1314492-2024-03092
• Device Sequence Number: 3689198
• Product Code: FRN
• UDI-Device Identifier: 00085412718378
• UDI-Public: (01)00085412718378(10)0004F35170E7(17)241025
• 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): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Health Professional,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 05/02/2025

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 Expiration Date: 10/25/2024
• Device Model Number: 36010
• Device Catalogue Number: 36010
• Device Lot Number: N/A
• 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: 09/05/2024
• Supplement Date Received by Manufacturer: 04/04/2025
• Initial Report FDA Received Date: 10/04/2024
• Supplement Report FDA Received Date: 05/02/2025
• 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
• Concomitant Medical Products and Therapy/Usage Dates: EPINIEPHRINE.; LACTATED RINGERS.; SIGMA SPECTRUM INFUSION PUMP 2056279.
• Outcome Attributed to Adverse Event: Death
• Patient Sex: Unknown