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

Model Number	35700BAX
Medical Device Problem Codes	False Alarm (1013); Filling Problem (1233)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/25/2026
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a spectrum infusion pump inadvertently administered the entire infusion of amiodarone and not the set amount that was programmed during a bolus infusion during delivery in intensive coronary care unit (iccu).There was no report of patient injury or medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
The device was received for evaluation.During functional testing, the customer reported problem of " during a bolus infusion it inadvertently administered the entire infusion and not the set amount that was programmed." was not reproduced due to downstream occlusion alarm.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 determined to be downstream force sensor no tube to be out of specification.The downstream force sensor scale factor calibration requires to be calibrated 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: 24945550
• Report Number: 1314492-2026-00825
• Device Sequence Number: 10092699
• 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
• Report Date (Section B): 04/21/2026

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: 04/06/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 03/25/2026
• Initial Report FDA Received Date: 04/21/2026
• 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: AMIODARONE
• Patient Sex: Unknown