MAUDE Adverse Event Report: SPECTRUM MEDICAL LIMITED QUANTUM CENTRIFUGAL DRIVES; BLOOD PUMP

Model Number	QCD37
Medical Device Problem Code	Pumping Problem (3016)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/23/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
On initial inspection of the device, there was damage noted on the outside shell.Once removed, there was evidence of a fluid, potentially blood, inside.Therefore, it is likely the device was damaged, allowing liquid ingress.
Event or Problem Description
User reported that there was no forward flow and some rerograde air coming back toward the arterial pump during start-up when priming the device.The user rebooted the pump then used it to successfully complete the case.We consider pump stoppages to be reportable.There was no patient involvement during the pump stoppage, and no harm to the patient when the pump was successfully used within the surgery.

• Brand Name: QUANTUM CENTRIFUGAL DRIVES
• Common Device Name: BLOOD PUMP
• Manufacturer (Section D): SPECTRUM MEDICAL LIMITED; harrier 4; meteor business park; cheltenham road east, gloucestershire GL29Q L; UK GL29QL
• Manufacturer (Section G): SPECTRUM MEDICAL LIMITED; harrier 4; meteor business park; cheltenham road east, gloucestershire GL29Q L; UK GL29QL
• Manufacturer Contact: edward blogg ; harrier 4; meteor business park; cheltenham road east, gloucestershire GL29Q-L ; UK GL29QL
• MDR Report Key: 21281183
• Report Number: 3006073153-2025-00027
• Device Sequence Number: 7782115
• Product Code: KFM
• UDI-Device Identifier: 05060434421838
• UDI-Public: 05060434421838
• Combination Product (Y/N): N
• Initial Reporter State: NC
• Initial Reporter Country: US
• PMA/510(K) Number: K192850
• 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): 01/31/2025

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: 10/26/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/23/2023
• Initial Report FDA Received Date: 01/31/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 10/03/2022
• 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