MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION SPECTRUM WITH MDL; PUMP, INFUSION

Model Number	35700BAX
Medical Device Problem Code	Excess Flow or Over-Infusion (1311)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
The device was not returned; 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 spectrum infusion pump over-infused inflectra during patient infusion.The patient infusion takes around 2 hours but the infusion was completed in 1 hour and 28 minutes.Patient received 405mg of inflectra based on her body weight for the days visit to the clinic.The medication was reconstituted with 10mls of sterile water and five vials were used.A 250ml bag was used to mix medication with 40.5mls removed from the bag and 40.5mls of medication added to the bag.The pump was set at 125mls/hr for a 250ml bag.The total time of infusion took 1 hour and 28mins.The patient did not report any reactions at the end of the infusion and stayed in the clinic for a 15 minute monitoring period.No additional information is available.

• Brand Name: SPECTRUM WITH MDL
• Common Device Name: PUMP, INFUSION
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - MEDINA; 711 park avenue; medina NY 14103
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242705355
• MDR Report Key: 24291684
• Report Number: 1314492-2026-00304
• Device Sequence Number: 13120565
• Product Code: FRN
• UDI-Device Identifier: 00085412091570
• UDI-Public: (01)00085412091570
• Combination Product (Y/N): N
• Initial Reporter State: MI
• Initial Reporter Country: US
• PMA/510(K) Number: K133801
• 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): 02/09/2026

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: 35700BAX
• Device Catalogue Number: 35700BAX
• Device Lot Number: N/A
• Was Device Available for Evaluation?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 01/13/2026
• Initial Report FDA Received Date: 02/09/2026
• 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: INFLECTRA; IV SET TCBINF6419
• Patient Sex: Unknown