MAUDE Adverse Event Report: SPECTRUM MEDICAL LIMITED QUANTUM PUMP CONSOLE; HEART-LUNG MACHINE

Model Number	QRP4
Medical Device Problem Code	Pumping Problem (3016)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	10/04/2023
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
A visual inspection found no fault to either the cable or the pump.Pump functionality tested with no fault found.Intermittent communication issues most likely due to liquid ingress, and therefore the pump was removed and replaced as a precautionary measure.
Event or Problem Description
Perfusionist reported that the pump would not stop when instructed via the knob or touchscreen.A back up was used to complete the case successfully.We consider inability to control a pump to be reportable, despite no harm to the patient involved.

• Brand Name: QUANTUM PUMP CONSOLE
• Common Device Name: HEART-LUNG MACHINE
• Manufacturer (Section D): SPECTRUM MEDICAL LIMITED; harrier4, meteor business park; cheltenham road east; gloucester, gloucestershire GL2 9 QL; UK GL2 9QL
• Manufacturer (Section G): SPECTRUM MEDICAL LIMITED; harrier4, meteor business park; cheltenham road east; gloucester, gloucestershire GL2 9 QL; UK GL2 9QL
• Manufacturer Contact: edward blogg ; harrier4, meteor business park; cheltenham road east; gloucester, gloucestershire GL2 9-QL ; UK GL2 9QL
• MDR Report Key: 20816771
• Report Number: 3006073153-2024-00112
• Device Sequence Number: 15416540
• Product Code: DTQ
• UDI-Device Identifier: 05060434420794
• UDI-Public: 05060434420794
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 12/02/2024

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: QRP4
• Device Catalogue Number: 51-000011-00
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/01/2023
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 10/04/2023
• Initial Report FDA Received Date: 12/02/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 01/12/2021
• 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