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

Model Number	35700BAX
Medical Device Problem Code	False Alarm (1013)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
E1: initial reporter phone no.(b)(6).H11: should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that a spectrum infusion pump displayed an air-in-line alarm during an unspecified process step.There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
Additional information: d9, h3, h6, h11.H11: the device was received for evaluation.During functional testing, the reported problem "air-in-line" was reproduced.Evaluation sent the device for upstream air testing.While the device ran infusions during the testing, it alarmed for air in line multiple times.A review of the event history log revealed "air-in-line!" messages.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 the upstream values out of specification.The ultrasonic sensor required to be replaced to address this issue.Should additional relevant information become available, a supplemental report will be submitted.

• 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: 24343434
• Report Number: 1314492-2026-00359
• Device Sequence Number: 15930831
• Product Code: FRN
• UDI-Device Identifier: 00085412091570
• UDI-Public: (01)00085412091570
• Combination Product (Y/N): N
• Initial Reporter State: WA
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 03/12/2026

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
• 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: 01/22/2026
• Supplement Date Received by Manufacturer: 02/17/2026
• Initial Report FDA Received Date: 02/16/2026
• Supplement Report FDA Received Date: 03/12/2026
• 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
• Patient Sex: Unknown