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

Model Number	QWS15S
Medical Device Problem Code	Increased Pump Speed (1501)
Health Effect - Clinical Code	No Clinical Signs, Symptoms or Conditions (4582)
Date of Event	06/03/2024
Type of Reportable Event	Malfunction
Event or Problem Description
Customer reported an event where the following took place during a cardiopulmonary bypass procedure: 1.High pressure event stopped cardioplegia pump.2.After pressure relief, pump started with high rpm instead of slowly regulating -> frequency of occurrence 2-3 times.No consequences to patient (i.E., no harm) as a result of this event.
Additional Manufacturer Narrative
Being on site the phenomenon could be reproduced once out of appr.15 times.-> set up: ratio @ 0:1 flow set to max 1.5l/min => to avoid a high flow rate in case of recurrence, the flow rate in the settings was set to 0.5 for safety.Reasons: checked all sap connections okay.Checked sensor functionalities okay(flow, level, pressure).System will be in use again.Csv file requested to be sent from customer for further investigation.

• Brand Name: QUANTUM PUMP CONSOLE
• Common Device Name: QUANTUM HEART LUNG MACHINE
• Manufacturer (Section D): SPECTRUM MEDICAL LTD; herrier4, meteor business park; cheltenham road east; gloucester, GL2 9 QL; UK GL2 9QL
• Manufacturer (Section G): SPECTRUM MEDICAL LTD; harrier4, meteor business park; cheltenham road east; gloucester, GL2 9 QL; UK GL2 9QL
• Manufacturer Contact: asia lukuc ; harrier4, meteor business park; cheltenham road east; gloucester, GL2 9-QL ; UK GL2 9QL
• MDR Report Key: 19679521
• Report Number: 3006073153-2024-00012
• Device Sequence Number: 15162544
• Product Code: DTQ
• UDI-Device Identifier: 05060434420008
• UDI-Public: 05060434420008
• Combination Product (Y/N): N
• Initial Reporter Country: GM
• 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): 07/05/2024

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: QWS15S
• Device Catalogue Number: 51-000001-00
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Initial
• Initial Date Received by Manufacturer: 06/12/2024
• Initial Report FDA Received Date: 07/05/2024
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Date Device Manufactured: 11/30/2021
• 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
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: QUANTUM ROLLER PUMP (AU4000908); QUANTUM ROLLER PUMP (AU4002417)
• Patient Sex: Unknown