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

Model Number	QCD37
Medical Device Problem Code	Pumping Stopped (1503)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	08/22/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation confirmed that one of the wires soldered onto the thermistor assembly had a failed solder joint.Thermistor assembly was replaced and tested again with no issues.
Event or Problem Description
Arterial pump tile read "arterial hardware fault" and rpms went to zero.Perfusionist noted zero flow and clamped lines.Centrifugal pump moved to hand crank and support to patient resumed after 1 minute.Decision made to replace centrifugal pump drive with new cp37 drive and new sap cable.Replacement showed no sign of error, pump moved over to new drive from hand crank.Flows resumed with no further alerts on arterial pump tile.

• Brand Name: QUANTUM CENTRIFUGAL 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: 20513155
• Report Number: 3006073153-2024-00070
• Device Sequence Number: 12934137
• 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: Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Remedial Action: Replace
• Type of Report: Initial
• Report Date (Section B): 10/15/2024

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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/04/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 08/22/2024
• Initial Report FDA Received Date: 10/23/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 07/19/2023
• 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