MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION SPECTRUM WITH MDL; PUMP, INFUSION

Model Number	35700BAX
Medical Device Problem Code	Excess Flow or Over-Infusion (1311)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/24/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received for evaluation.During functional testing, the reported problem "over -infused fentanyl" was not reproduced.Evaluation tested the pump for flow accuracy and the device passed the test.A service history review revealed no indication that the parts replaced during servicing caused or contributed to the reported event.The reported condition was not verified.The cause of the condition was undetermined however, to ensure flow accuracy evaluation required to replace the m2&m3 springs.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that a spectrum infusion pump over-infused fentanyl during delivery, infusion ended early.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
Additional information: h11: event history log revealed a fentanyl continuous infusion (1000mcg/100ml) was initiated at 14:46 and titrated throughout the day, reaching a dose of 200mcg/hr by 15:53.The infusion continued until 19:49, when the pump recorded an air in line alarm resulting in a pump stop.Multiple additional occurrences of ¿air in line!¿ alarms with corresponding pump stop and run events were observed between 20:50 and 20:55, requiring repeated user intervention.At 20:55, a user initiated stop was recorded, after which the infusion was not resumed and the pump subsequently entered inactivity and sleep modes.While multiple air in line alarms were documented in the history log, failure or performance of the air in line detection system cannot be determined from the ehl log.

• Brand Name: SPECTRUM WITH MDL
• 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 ; 2242705355
• MDR Report Key: 24670021
• Report Number: 1314492-2026-00619
• Device Sequence Number: 12041549
• Product Code: FRN
• UDI-Device Identifier: 00085412091570
• UDI-Public: (01)00085412091570
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• 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: User Facility,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/29/2026

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 Model Number: 35700BAX
• Device Catalogue Number: 35700BAX
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/03/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/25/2026
• Supplement Date Received by Manufacturer: 04/24/2026
• Initial Report FDA Received Date: 03/23/2026
• Supplement Report FDA Received Date: 04/29/2026
• 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: FENTANYL
• Patient Sex: Unknown