MAUDE Adverse Event Report: SPECTRUM MEDICAL LTD QUANTUM PRESSURE SENSOR ASSEMBLY - 2.0M

Model Number	QPR6
Medical Device Problem Code	Failure to Sense (1559)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	03/12/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation ongoing in order to identify the root cause of the reported issue.Further details will be discussed in a follow-up report.
Event or Problem Description
During the case, the pressure sensor used for the stop and max pressure of the arterial pump stopped.The perfusionist used the hand crank until the pressure sensor was deactivated and the pump could be started.Hand cranking lasted 2-3 minutes max.No harm occurred for the patient.
Additional Manufacturer Narrative
The faulty sensor, before this issue, never required maintenance and has not had any problems in the past.The analysis performed after the return of the device confirmed the reading value greater than >800mmhg.During inspection, has been found a visual damage on the sensor, hole in the pad sensor and a crack close to the pad.The cause of the broken pad was probably due to accidental damage by the user.
Event or Problem Description
During the case the pressure sensor read pressure values higher than 800 mmhg and as a consequence, the arterial pump stopped.The perfusionist used the hand crank until the pressure sensor was deactivated and the pump could be started.Handcranking lasted 2-3 minutes max.The case has been completed without any issue for the patient.

• Brand Name: QUANTUM PRESSURE SENSOR ASSEMBLY - 2.0M
• Common Device Name: PRESSURE SENSOR
• 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: raffaella tommasini ; ashville business park; commerce road; gloucester, gloucestershire GL2 9-SL ; UK GL2 9SL
• MDR Report Key: 24697128
• Report Number: 3006073153-2026-00099
• Device Sequence Number: 15979884
• Product Code: DRY
• UDI-Device Identifier: 05060434423306
• UDI-Public: 05060434423306
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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
• Remedial Action: Replace
• Type of Report: Initial,Followup
• Report Date (Section B): 05/27/2026

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Health Professional
• Device Model Number: QPR6
• Device Catalogue Number: 51-000139-00
• 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: 03/13/2026
• Supplement Date Received by Manufacturer: 03/13/2026
• Initial Report FDA Received Date: 03/26/2026
• Supplement Report FDA Received Date: 05/27/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/05/2023
• 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
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Sex: Unknown