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)
Date of Event	06/09/2026
Type of Reportable Event	Malfunction
Event or Problem Description
During evaluation of a returned novum iq syringe pump, the device alarmed system error 21502 (flange sensor failure).This occurred during evaluation, therefore, there was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
The device was received for evaluation.During evaluation of the returned device, a system error 21502 (flange sensor failure) occurred.A sticky substance was found inside plunger driver sleeve causing plunger driver to not open.A service history review revealed no indication that the parts replaced during servicing caused or contributed to the reported event.The mechanism and flange assembly required to be replaced to address this issue.Should additional relevant information become available, a supplemental report will be submitted.

• 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: 25763426
• Report Number: 1416980-2026-02271
• Device Sequence Number: 10537442
• Product Code: FRN
• UDI-Device Identifier: 05413765852428
• UDI-Public: (01)05413765852428
• Combination Product (Y/N): N
• Initial Reporter State: TN
• 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): 07/09/2026

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: Other
• 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: 06/08/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/09/2026
• Initial Report FDA Received Date: 07/09/2026
• 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