MAUDE Adverse Event Report: SPECTRUM MEDICAL LTD QUANTUM CENTRIFUGAL DRIVE - CP22; CENTRIFUGAL PUMP

Model Number	QCD - CP22
Medical Device Problem Code	Pumping Stopped (1503)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/01/2024
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Investigation of the physical device found evidence of fluid ingress on the pcb within the centrifugal pump drive which caused a short circuit.
Event or Problem Description
User reported that during a case the pump manager alerted for "no pump location 12" after which the user was unable to change the rpm of the pump.The user made the decision to handcrank the pump before hot swapping out the faulty drive to a new drive.The case concluded without any further issues.There was no patient harm.Spectrum medical considers inability to control pump speed a reportable malfunction.

• Brand Name: QUANTUM CENTRIFUGAL DRIVE - CP22
• Common Device Name: CENTRIFUGAL PUMP
• Manufacturer (Section D): SPECTRUM MEDICAL LTD; harrier4, meteor business park; cheltenham road east; gloucester, gloucestershire GL29Q L; UK GL29QL
• Manufacturer (Section G): SPECTRUM MEDICAL LTD; 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: 21251062
• Report Number: 3006073153-2025-00012
• Device Sequence Number: 21101636
• Product Code: KFM
• UDI-Device Identifier: 05060434421821
• UDI-Public: 05060434421821
• Combination Product (Y/N): N
• Initial Reporter State: CT
• Initial Reporter Country: US
• 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): 01/28/2025

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: QCD - CP22
• Device Catalogue Number: 51-000061-00
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/07/2024
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/01/2024
• Initial Report FDA Received Date: 01/28/2025
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/23/2023
• 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