MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION SIGMA Spectrum Infusion Pump; Pump, infusion

Model Number	35700BAX2
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
Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that a spectrum pump alarmed constant downstream occlusion.This occurred during an unspecified process step.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

• Brand Name: SIGMA Spectrum Infusion Pump
• 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 ; +1(224)270-5355
• MDR Report Key: 50900432
• Report Number: 1314492-2026-02087
• Device Sequence Number: 5903772
• Product Code: FRN
• UDI-Device Identifier: 00085412498683
• UDI-Public: (01)00085412498683
• Combination Product (Y/N): N
• Initial Reporter State: NA
• Initial Reporter Country: CA
• PMA/510(K) Number: K251640
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Foreign,User Facility,Company Representative
• Type of Report: Initial
• Report Date (Section B): 09/25/2026

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: 35700BAX2
• Device Catalogue Number: 35700BAX2
• 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: 09/08/2026
• Initial Report FDA Received Date: 09/25/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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