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

Model Number	40700BAXUS
Medical Device Problem Code	Failure to Sense (1559)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
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 did not alarm when an occlusion was present.This was observed during an unspecified process step.There was no report of patient injury or medical intervention associated with this event.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: 25538267
• Report Number: 1416980-2026-02059
• Device Sequence Number: 9313252
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Biomedical Engineer
• Type of Report: Initial,Followup
• Report Date (Section B): 07/18/2026

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?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/19/2026
• Supplement Date Received by Manufacturer: 07/13/2026
• Initial Report FDA Received Date: 06/17/2026
• Supplement Report FDA Received Date: 07/18/2026
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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