MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION Novum IQ; Pump, infusion

Model Number	40800BAXUS
Medical Device Problem Codes	Backflow (1064); Filling Problem (1233)
Health Effect - Clinical Code	Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	06/29/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a novum iq syringe pump underinfused fentanyl infusion and allowed iv fluids to back up into the medication syringes.The patient was receiving continuous infusions through a 4 french right internal jugular (rij) central line, including dextrose 5% in 0.9% sodium chloride at 18 ml/hour via large volume pump (lvp), fentanyl administered at 0.47 ml/hour, midazolam administered at 0.47 ml/hour, and precedex administered at 0.71 ml/hour.Fentanyl, midazolam and precedex were administered using three separate novum iq syringe pumps.During infusion verification in the electronic medical record, an error message was encountered stating, ¿unable to calculate volume.The volume calculator has detected a potential negative rate or volume and could not suggest a calculation.¿ staff attempted to determine the cause of the error but were unable to identify an explanation.The infusion pumps were subsequently manually cleared.Following clearance, the midazolam syringe pump displayed a negative volume value of -0.814 ml despite the infusion having run for approximately two hours.In addition, approximately three hours after initiation, the midazolam syringe reportedly still contained the original 30 ml volume.The fentanyl syringe pump did not display a negative value when cleared, and the recorded total volume appeared appropriate; however, the fentanyl syringe reportedly still contained the original 50 ml volume loaded at infusion initiation despite approximately three hours of therapy having elapsed.No alarms or malfunction indicators were reported from the pumps.During this period, the patient required increasing doses of sedative medication to maintain adequate sedation and comfort.A concern was identified that carrier iv fluids may have backflowed into the fentanyl and midazolam syringes, potentially diluting the medications and affecting delivery to the patient.In response, the syringe pumps were replaced and sequestered for evaluation.New fentanyl and midazolam syringes were prepared and initiated due to concerns regarding possible dilution from iv fluid backflow.Additionally, the carrier fluid was changed from dextrose 5% in 0.9% sodium chloride administered at 18 ml/hour to a normal saline carrier administered at 3 ml/hour.Following these interventions, the patient was reportedly significantly more sedated within approximately two hours.By the end of the shift, total infusion volumes were consistent with expected calculations, medication syringes demonstrated appropriate volume depletion based on programmed infusion rates, and no further volume discrepancies were observed.No additional information is available at this time.
Additional Manufacturer Narrative
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 NA 51000 ; TH 51000
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; +1(224)270-5355
• MDR Report Key: 50040050
• Report Number: 1416980-2026-02448
• Device Sequence Number: 10556167
• Product Code: FRN
• UDI-Device Identifier: 05413765852428
• UDI-Public: (01)05413765852428
• Combination Product (Y/N): N
• Initial Reporter State: OK
• Initial Reporter Country: US
• PMA/510(K) Number: K242390
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional,User Facility,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 09/09/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: 40800BAXUS
• Device Catalogue Number: 40800BAXUS
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 06/30/2026
• Supplement Date Received by Manufacturer: 09/04/2026; 08/12/2026
• Initial Report FDA Received Date: 07/27/2026
• Supplement Report FDA Received Date: 09/07/2026; 09/09/2026
• 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
• Concomitant Medical Products and Therapy/Usage Dates: Dextrose 5% in 0.9% sodium chloride; Fentanyl; Midazolam; Novum IQ syringe pump; Novum IQ syringe pump; Precedex; Right internal jugular (RIJ) central line; Unspecified brand large volume pump
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Age: 14 DA
• Patient Sex: Unknown