MAUDE Adverse Event Report: SPECTRUM MEDICAL LIMITED QUANTUM CENNTRIFUGAL DRIVE - CP37; CENTRIFUGAL PUMP DRIVE

Model Number	QCD37
Medical Device Problem Code	Increase in Pressure (1491)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Conclusion and root cause awaiting completion of investigation.
Event or Problem Description
User reported that while on cpb, a pressure spike of >350 progressing to >400 occurred.No flow at this point due to pressure stop link.Line troubleshooting was done for kinks and triggered arterial occluder but nothing was noted.Flow was reinstated with the use for handcranking.The user tried recalibrating and re-zeroing the pressure transducer, but this did not solve the issue.The pressure transducer was replaced after which pressure was appropriate for flow.Surgery was resumed and pressure was appropriate for the rest of the case.No harmful patient effects noted.

• Brand Name: QUANTUM CENNTRIFUGAL DRIVE - CP37
• Common Device Name: CENTRIFUGAL PUMP DRIVE
• 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: 20189244
• Report Number: 3006073153-2024-00059
• Device Sequence Number: 8138022
• Product Code: DWA
• UDI-Device Identifier: 05060434421838
• UDI-Public: 05060434421838
• Combination Product (Y/N): N
• Initial Reporter Country: CA
• PMA/510(K) Number: K192838
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: 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: QCD37
• Device Catalogue Number: 51-000062-00
• 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: 08/02/2024
• Initial Report FDA Received Date: 09/11/2024
• Was Device Evaluated by Manufacturer? (Y/N): No
• Date Device Manufactured: 09/01/2023
• 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