MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION NOVUM IQ; PUMP, INFUSION

Model Number	40800BAXUS
Medical Device Problem Code	Protective Measures Problem (3015)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received for evaluation.During functional testing, the reported system error (se) 21503; the pump alarmed shortly after being turned on.Downstream occlusion sensor testing and calibration were performed with failing results.A review of the event history log identified a se 21503 occlusion sensor railed failure message.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 due to the plunger driver flex not properly installed.The plunger driver flex would be properly installed to address the issue.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that a novum iq syringe pump alarmed system error 21503 (occlusion sensor railed failure).This was observed during an unspecified process step in the biomed service department.There was no patient involvement.No additional information is available.

• Brand Name: NOVUM IQ
• Common Device Name: PUMP, INFUSION
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): ORBRAY THAILAND CO., LTD.; northern region ind. estate; 60/29 moo 4, tambol banklang; a.muang, ban klang, lamphun 51000 ; TH 51000
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242705355
• MDR Report Key: 25490757
• Report Number: 1416980-2026-01989
• Device Sequence Number: 10449094
• Product Code: FRN
• UDI-Device Identifier: 05413765852428
• UDI-Public: (01)05413765852428
• Combination Product (Y/N): N
• Initial Reporter State: MO
• Initial Reporter Country: US
• PMA/510(K) Number: K242390
• 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): 06/12/2026

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: 40800BAXUS
• Device Catalogue Number: 40800BAXUS
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/27/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/14/2026
• Initial Report FDA Received Date: 06/12/2026
• 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