MAUDE Adverse Event Report: SPECTRUM MEDICAL LIMITED QUANTUM WORKSTATION; MONITOR

Model Number	QWS15S
Medical Device Problem Codes	Pumping Stopped (1503); Improper or Incorrect Procedure or Method (2017)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	05/14/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Logs showed bubble alarms sounded, causing pump stop.Pressure in the system may have caused the retrograde flow whilst pump was inactive.The system acted as expected in response to a bubble in the circuit.The logs show the bubble resolved itself, and the pump was operational when swapped for hand crank.
Event or Problem Description
Perfusionist reported that several alarms sounded, and experienced a pump stop during a case.They were unable to diagnose reason for both, leading to the perfusionist switching to use a hand crank as a precautionary measure and switching pump out - after observing retrograde flow.We consider a pump stop to be reportable; however, the patient was involved without any consequences.

• Brand Name: QUANTUM WORKSTATION
• Common Device Name: MONITOR
• Manufacturer (Section D): SPECTRUM MEDICAL LIMITED; harrier4, meteor business park; cheltenham road east; gloucester, gloucestershire GL2 9 QL; UK GL2 9QL
• Manufacturer (Section G): SPECTRUM MEDICAL LIMITED; harrier4, meteor business park; cheltenham road east; gloucester, gloucestershire GL2 9 QL; UK GL2 9QL
• Manufacturer Contact: edward blogg ; harrier4, meteor business park; cheltenham road east; gloucester, gloucestershire GL2 9-QL ; UK GL2 9QL
• MDR Report Key: 20607842
• Report Number: 3006073153-2002-00086
• Device Sequence Number: 17976061
• Product Code: DRY
• UDI-Device Identifier: 05060434422293
• UDI-Public: 05060434422293
• Combination Product (Y/N): N
• Initial Reporter State: TX
• Initial Reporter Country: US
• PMA/510(K) Number: K163657
• 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): 11/01/2024

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: QWS15S
• Device Catalogue Number: 51-000093-00
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 05/14/2024
• Initial Report FDA Received Date: 11/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/05/2023
• 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
• Patient Sex: Unknown