MAUDE Adverse Event Report: SPECTRUM MEDICAL LTD HB-SO2 TWIN SENSOR ID 3/8" X WALL 3/32" (OD 9/16") 2M; MONITOR, BLOOD-GAS, ON-LINE, CARDIOPULMONARY BYPASS

Model Number	HBS4-200
Medical Device Problem Code	Incorrect Measurement (1383)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/12/2026
Type of Reportable Event	Malfunction
Event or Problem Description
User reported that the saturation value was incorrectly measured, but system did not detect an issue.The user knew to reset the sensor to resolve the issue, so there was no patient harm; however, recurrence of the problem could result in patient harm.
Additional Manufacturer Narrative
Root cause determination is pending the investigation.
Additional Manufacturer Narrative
Investigation confirmed reported fault and found blockage in the arterial fiber.The unit was scrapped to prevent further use.
Event or Problem Description
User reported that the saturation value was incorrectly measured, but system did not detect an issue.The user knew to reset the sensor to resolve the issue, so there was no patient harm; however, recurrence of the problem could result in patient harm.

• Brand Name: HB-SO2 TWIN SENSOR ID 3/8" X WALL 3/32" (OD 9/16") 2M
• Common Device Name: MONITOR, BLOOD-GAS, ON-LINE, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): SPECTRUM MEDICAL LTD; ashville business park; commerce road; gloucester, gloucestershire GL2 9 SL; UK GL2 9SL
• Manufacturer (Section G): SPECTRUM MEDICAL LTD; ashville business park; commerce road; gloucester, gloucestershire GL2 9 SL; UK GL2 9SL
• Manufacturer Contact: cameron schmitt ; 481 munn road; suite 180; fort mill, SC 29715
• MDR Report Key: 24589826
• Report Number: 3006073153-2026-00080
• Device Sequence Number: 9271921
• Product Code: DRY
• UDI-Device Identifier: 05060434420602
• UDI-Public: 05060434420602
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K173591
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 03/23/2026

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: HBS4-200
• Device Catalogue Number: 51-000037-00
• Device Lot Number: TR1001779
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/12/2026
• Supplement Date Received by Manufacturer: 02/12/2026
• Initial Report FDA Received Date: 03/13/2026
• Supplement Report FDA Received Date: 03/23/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 02/12/2024
• 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