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

Model Number	40700BAXUS
Medical Device Problem Codes	Excess Flow or Over-Infusion (1311); Protective Measures Problem (3015)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was received for evaluation.The event history log review identified a se 20602 on the event date reported.The device was able to successfully load and run an infusion with no discrepancies.Functional flow rate accuracy testing was performed and the device met specifications; the se was not reproduced during testing.A device history review revealed no issues that could have caused or contributed to the reported issue.The reported se was verified; however, the over-infusion issue was not verified.The cause of the se could not be determined.No device correction was needed for this event.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that a novum iq large volume pump ran at higher rate than programmed (over-infusion).This was observed during an unspecified process step in the emergency room.There was no report of patient injury or medical intervention associated with this event.Additionally, a system error (se) 20602 (monitor motor stall) was identified during device evaluation.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: 25732959
• Report Number: 1416980-2026-02246
• Device Sequence Number: 10645744
• Product Code: FRN
• UDI-Device Identifier: 05413765851797
• UDI-Public: (01)05413765851797
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• PMA/510(K) Number: K211122
• 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): 07/07/2026

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: 40700BAXUS
• Device Catalogue Number: 40700BAXUS
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/17/2026
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/08/2026
• Initial Report FDA Received Date: 07/07/2026
• 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