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

Model Number	Quantum Workstation (QWS)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/22/2020
Type of Reportable Event	Malfunction
Event or Problem Description
The incident occurred about 5 minutes after the establishment of cpb.Patient was on cpb for the repair of an emergency aortic dissection.As the ascending aorta was to be replaced/repaired the cpb circuit consisted of one for the systemic circulation and one for the cerebral circulation.The cerebral circulation inlet branched off the arterial line of the cpb circuit.The cerebral circuit was flowing at just over a one litre per minute.Surgeon asked for patient to be filled, occluding the venous line filled the patient and decreased the volume in the reservoir, the reservoir volume dropped triggering the safe flow sensor.The triggering of the safe flow sensor drops the arterial pump to equal what is flowing through the venous line, in this instance the cerebral flow was greater than the arterial flow and therefore, air was dragged across the oxygenator membrane.The perfusionists had interlocked the cerebral pump to the arterial pump and assumed that as the arterial pump flows dropped so would the cerebral pump flows.The perfusionists at the time noted that air had been dragged across the membrane and that it had entered the cerebral circuit.Surgeon also noticed the air in the line.Cerebral circulation was stopped until air was cleared from line.Air was cleared from the oxygenator and perfusion recommenced and the case was completed with no other issues.

• Brand Name: QUANTUM PUMP CONSOLE
• Common Device Name: HEAT LUNG MACHINE
• Manufacturer (Section D): SPECTRUM MEDICAL LTD; harrier4, meteor business park; cheltenham rd east; gloucester GL2 9
• MDR Report Key: 12656817
• Report Number: 3001073153-2020-00004
• Device Sequence Number: 4714076
• Product Code: DTQ
• UDI-Device Identifier: 05060434420008
• UDI-Public: 05060434420008
• Combination Product (Y/N): N
• Initial Reporter Country: AS
• PMA/510(K) Number: K173834
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: health professional,user faci
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/25/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Operator of Device: Health Professional
• Device Model Number: Quantum Workstation (QWS)
• Device Catalogue Number: 51-000001-00
• Was Device Available for Evaluation?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 09/25/2020
• Initial Report FDA Received Date: 10/19/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Required Intervention
• Patient Age: 50 YR