MAUDE Adverse Event Report: SPECTRUM MEDICAL LTD. QUANTUM POWER SUPPLY; CARDIOPULMONARY BYPASS SYSTEM ROLLER PUMP - POWER SUPPLY

Model Number	QWS
Medical Device Problem Code	Intermittent Loss of Power (4016)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	02/04/2026
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Service reviewed the logs for this event and believe that the actual affected device is the quantum power supply or the frame.Device to be investigated on return to hq.
Event or Problem Description
While on bypass, the arterial flow probe/bubble is intermittently going offline.The occluder was swapped yet the issue continued happening.

• Brand Name: QUANTUM POWER SUPPLY
• Common Device Name: CARDIOPULMONARY BYPASS SYSTEM ROLLER PUMP - POWER SUPPLY
• Manufacturer (Section D): SPECTRUM MEDICAL LTD.; ashville business park; commerce road; gloucester, gloucestershire GL29S L; UK GL29SL
• Manufacturer (Section G): SPECTRUM MEDICAL; ashville business park; commerce road; gloucester, gloucestershire GL29S L; UK GL29SL
• Manufacturer Contact: raffaella tommasini ; ashville business park; commerce road; gloucester, gloucestershire GL29S-L ; UK GL29SL
• MDR Report Key: 24510985
• Report Number: 3006073153-2026-00040
• Device Sequence Number: 9943412
• Product Code: DTQ
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K173834
• 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
• Report Date (Section B): 03/04/2026

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: QWS
• Device Catalogue Number: 51-000021-00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/04/2026
• Initial Report FDA Received Date: 03/04/2026
• 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
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown