MAUDE Adverse Event Report: SPECTRUM MEDICAL LTD QUANTUM; RESERVOIR LEVEL SENSOR

Catalog Number	51-000070-00
Medical Device Problem Code	Calibration Problem (2890)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/26/2026
Type of Reportable Event	Malfunction
Event or Problem Description
Head of perfusion (b)(6) reported error 10810 for the quantum level sensor during initiation mode.The sensor has been deactivated and the case finished successfully.Upon request there were no consequences or harm for the patient as confirmed by the perfusionist.
Additional Manufacturer Narrative
Investigation opened.Manufacturers conclusion to follow.

• Brand Name: QUANTUM
• Common Device Name: RESERVOIR LEVEL SENSOR
• Manufacturer (Section D): SPECTRUM MEDICAL LTD; commerce road; ashville business park; gloucester, gloucestershire GL29S L; UK GL29SL
• Manufacturer (Section G): SPECTRUM MEDICAL LTD; commerce road; ashville business park; gloucester, gloucestershire GL29S L; UK GL29SL
• Manufacturer Contact: raffaella tommasini ; commerce road; ashville business park; gloucester, gloucestershire GL29S-L ; UK GL29SL
• MDR Report Key: 24493970
• Report Number: 3006073153-2026-00035
• Device Sequence Number: 10617332
• Product Code: DTX
• UDI-Device Identifier: 05060434421906
• UDI-Public: 05060434421906
• Combination Product (Y/N): N
• Initial Reporter Country: SZ
• PMA/510(K) Number: K202733
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Company Representative
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 04/09/2026

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 Catalogue Number: 51-000070-00
• 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: 02/26/2026
• Supplement Date Received by Manufacturer: 02/26/2026
• Initial Report FDA Received Date: 03/03/2026
• Supplement Report FDA Received Date: 05/05/2026
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 09/10/2024
• 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