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

Model Number	40800BAXUS
Medical Device Problem Code	Backflow (1064)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
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).Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported that there was backflow of normal saline into the syringe during use of a novum iq syringe pump.The patient had one intravenous (iv) access.A peripheral intravenous line, normal saline fluids, and three stopcocks were hooked into iv hub.From the iv site, the first stopcock was open to all sides and had fentanyl running on the syringe pump.The second stopcock was open to all sides and had propofol running on an unspecified large volume pump (lvp).The third stopcock was capped and closed to the empty port.Normal saline ¿was running at the back as the mivf/carrier at 40-50 an hour on a lvp¿.Physician ordered a bolus of normal saline, and the normal saline lvp was reprogramed to 999 ml/hr to deliver bolus."lvp and syringe pump alarmed downstream occlusion but would restart".Fentanyl syringe popped out of syringe pump and when placed back into the syringe pump, the pump alarmed that the syringe had 55 mls, which was more than expected.The nurse realized the syringe had 15 or more mls of extra fluid in the syringe.The patient¿s pain control was interrupted.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: 25462236
• Report Number: 1416980-2026-01965
• Device Sequence Number: 21013932
• 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
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 07/13/2026

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: 40800BAXUS
• Device Catalogue Number: 40800BAXUS
• 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: 05/13/2026
• Supplement Date Received by Manufacturer: 06/15/2026
• Initial Report FDA Received Date: 06/10/2026
• Supplement Report FDA Received Date: 07/13/2026
• 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: FENTANYL; NORMAL SALINE
• Patient Sex: Unknown