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

Model Number	35700BAX2
Medical Device Problem Code	Excess Flow or Over-Infusion (1311)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a spectrum pump infused too quickly (over infused) during patient infusion.The programmed infusion parameters were expected to be 30 ml volume to be infused, with the corresponding infusion time and flow rate set accordingly.However, the actual delivered volume was 300 ml.The patient was connected to the pump during the event.According to the clinician, the pump was programmed to infuse 30 ml, but 300 ml was delivered.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
E1 initial reporter phone no.: (b)(6).Should additional relevant information become available, a supplemental report will be submitted.

• 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: 50803888
• Report Number: 1314492-2026-02028
• Device Sequence Number: 10611038
• Product Code: FRN
• UDI-Device Identifier: 00085412498683
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K251640
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial
• Report Date (Section B): 09/17/2026

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: 08/31/2026
• Initial Report FDA Received Date: 09/17/2026
• 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