MAUDE Adverse Event Report: SPECTRUM MEDICAL LIMITED QUANTUM ROLLER PUMP (PART OF QUANTUM PUMP CONSOLE); HEART LUNG MACHINE

Model Number	QRP8
Medical Device Problem Code	Pumping Stopped (1503)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/12/2024
Type of Reportable Event	Malfunction
Event or Problem Description
User reported that during bypass, arterial roller pump began briefly stopping and restarting without any error messages or alarms.The perfusionist chose to continue bypass with pump, behaviour stopped occurring around 30 minutes before bypass was ended.Pump was inspected immediately after case.Pump was run at max rpm, with and without tubing, and with and without external power.Sap cable was manipulated, roller head was turned to both stops, and lid was pushed and open/closed.Error was not reproducible.Outer case was inspected for damage, none found.Case was removed and ground clips inspected and appeared to be making contact.
Additional Manufacturer Narrative
Conclusion awaiting results of investigation.

• Brand Name: QUANTUM ROLLER PUMP (PART OF QUANTUM PUMP CONSOLE)
• Common Device Name: HEART LUNG MACHINE
• Manufacturer (Section D): SPECTRUM MEDICAL LIMITED; harrier4, meteor business park; cheltenham road east; gloucester, gloucestershire GL29Q L; UK GL29QL
• Manufacturer (Section G): SPECTRUM MEDICAL LIMITED; harrier4, meteor business park; cheltenham road east; gloucester, gloucestershire GL29Q L; UK GL29QL
• Manufacturer Contact: angus fletcher ; harrier4, meteor business park; cheltenham road east; gloucester, gloucestershire GL29Q-L ; UK GL29QL
• MDR Report Key: 20210965
• Report Number: 3006073153-2024-00061
• Device Sequence Number: 18093127
• Product Code: DTQ
• UDI-Device Identifier: 05060434420770
• UDI-Public: 05060434420770
• Combination Product (Y/N): N
• Initial Reporter State: VA
• Initial Reporter Country: US
• 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,User Facility
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/11/2024

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: QRP8
• Device Catalogue Number: 51-000008-00
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/03/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 08/12/2024
• Initial Report FDA Received Date: 09/13/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 10/30/2020
• 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
• Patient Sequence Number: 1
• Patient Sex: Unknown