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

Model Number	40800BAXUS
Medical Device Problem Code	Filling Problem (1233)
Health Effect - Clinical Codes	Tachycardia (2095); Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available (4581)
Date of Event	07/11/2026
Type of Reportable Event	Serious Injury
Event or Problem Description
It was reported that a novum iq syringe pump underinfused continuous morphine for pain/sedation.The patient was concurrently receiving a continuous d30 fluid infusion and vecuronium through other syringe pumps.During initial setup, a 10 ml syringe was selected and dispensed.After priming, the syringe was reloaded, and the pump reportedly offered a 50 ml syringe option, which was confirmed by the user.Subsequently, multiple ¿disposable not loaded¿ messages were reportedly recorded; however, no associated syringe reload events or user re-confirmations of syringe size/type were identified for the corresponding ¿syringe loading complete¿ entries.The reporter stated that the patient became tachycardic and appeared to be awakening despite paralysis, suggesting inadequate sedation despite increasing sedation doses.No additional information is available.
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: 50212916
• Report Number: 1416980-2026-02610
• Device Sequence Number: 9998982
• 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
• Reporter Type: Manufacturer
• Report Source: User Facility,Company Representative
• Type of Report: Initial
• Report Date (Section B): 08/11/2026

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: 07/23/2026
• Initial Report FDA Received Date: 08/11/2026
• 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: 10mL Syringe; D30 fluid and vecuronium; Morphine; Unspecified brand syringe pump
• Outcome Attributed to Adverse Event: Life Threatening
• Patient Sex: Unknown