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

Model Number	3570009
Medical Device Problem Code	Defective Alarm (1014)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported that a spectrum iq infusion pump failed downstream occlusion test during preventive maintenance.There was no patient involvement.No additional information is available.
Additional Manufacturer Narrative
The device was received for evaluation.During functional testing, the customer reported ¿failed downstream occlusion test¿ was reproduced.The device was tested for flow testing for downstream occlusion testing and failed.A review of the event history log revealed downstream occlusion messages.A service history review revealed no indication that the parts replaced during servicing caused or contributed to the reported event.The reported condition was verified.The cause of the condition was determined to be force sensor no tube calibration and force sensor scale factor calibration out of specification.The force sensor no tube and force sensor scale factor require calibration to address this issue.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: Spectrum IQ
• 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 ; +1(224)270-5355
• MDR Report Key: 50948947
• Report Number: 1314492-2026-02105
• Device Sequence Number: 21444166
• Product Code: FRN
• UDI-Device Identifier: 00085412610900
• Combination Product (Y/N): N
• Initial Reporter State: MN
• Initial Reporter Country: US
• PMA/510(K) Number: K251636
• 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): 09/30/2026

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: 3570009
• Device Catalogue Number: 3570009
• Device Lot Number: N/A
• Was Device Available for Evaluation?: Yes
• Date Returned to Manufacturer: 09/23/2026
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/10/2026
• Initial Report FDA Received Date: 09/30/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• 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
• Patient Sex: Unknown