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

Model Number	40700BAXUS
Medical Device Problem Code	Filling Problem (1233)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/14/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
D4: unique identifier (udi) #: the serial number (21) is unknown, therefore, the udi number only will contain the device identifier (01).The device was not returned and the serial number is unknown; therefore, a device analysis could not be completed.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 underinfused during infusion.The pump had meropenem programmed in to run over 3 hours.Infusion and flush completed roughly 3.5h after initiation and registered nurse noted that medication bag still had roughly half the volume remaining.The remainder of medication administered and next dose pushed forward 2 hours.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: 25552603
• Report Number: 1416980-2026-02085
• Device Sequence Number: 10741630
• Product Code: FRN
• UDI-Device Identifier: 05413765851797
• UDI-Public: (01)05413765851797
• Combination Product (Y/N): N
• 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): 06/18/2026

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
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 05/20/2026
• Initial Report FDA Received Date: 06/18/2026
• 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
• Concomitant Medical Products and Therapy/Usage Dates: MEROPENEM
• Patient Sex: Unknown