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
Event or Problem Description
It was reported that a spectrum pump repeatedly indicated ¿air in line¿ in location 1, despite no air being found.The line was replaced with a new set, but the alarm continued and the error could not be cleared.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.
Additional Manufacturer Narrative
E1 initial reporter phone no.: (b)(6).The device was received for evaluation.During functional testing, the customer reported issue of air in line was not reproduced.Instead, the device went into a reload set alarm when the door was shut.A review of the event history log revealed multiple occurrences of air-in-line messages.A service history review revealed no indication that the parts replaced during servicing caused or contributed to the reported event.The reported condition was verified.The cause of the condition was determined to be a bad lower sensor on the ultrasonic sensor which was unable to be calibrated.The ultrasonic sensor will 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: 24455714
• Report Number: 1314492-2026-00428
• Device Sequence Number: 9403487
• Product Code: FRN
• UDI-Device Identifier: 00085412091570
• UDI-Public: (01)00085412091570
• Combination Product (Y/N): N
• Initial Reporter State: IL
• 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
• Report Date (Section B): 02/26/2026

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: 02/10/2026
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/04/2026
• Initial Report FDA Received Date: 02/26/2026
• 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