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

Model Number	QWS
Health Effect - Clinical Code	Low Cardiac Output (2501)
Date of Event	07/16/2021
Type of Reportable Event	Malfunction
Additional Manufacturer Narrative
Per the log review, the protected level was selected not safe flow level.Therefore the system would never enter safe flow level condition for the pump to drop to 25% flow.The csv file also confirmed the arterial flow was never modulating.It went from 5lpm to 0lpm.Level sensor received from customer and inspected by spectrum inc, after examining and testing the sensor no damage or malfunction was found.Patient was released from hospital after procedure the same day.
Event or Problem Description
Clinician reports that circuit began losing venous flow causing safe flow to engage.Clinician does not have a venous flow probe on his circuit so arterial flow dropped to 25% of last know flow.Clinician notes seeing arterial pump slow.Clinician also states that interlocked uf pump continued to spin at same rate despite arterial pump slowing.Clinician then states that protected flow level was hit and arterial pump stopped.Clinician states that interlocked uf continued to spin.Clinician states that air was entrained in the membrane.Patient came off bypass for approximately 1 minute to de-air membrane.Patient was hypotensive during and after event but was otherwise stable.

• Brand Name: QUANTUM PUMP CONSOLE
• Common Device Name: HEART LUNG MACHINE
• Manufacturer (Section D): SPECTRUM MEDICAL LTD; harrier4, meteor business park; cheltenham rd east; gloucester, GL2 9 QL,; UK GL2 9QL,
• MDR Report Key: 12353161
• Report Number: 3006073153-2021-00008
• Device Sequence Number: 19879077
• Product Code: DTQ
• UDI-Device Identifier: 05060434422293
• UDI-Public: 5060434422293
• Combination Product (Y/N): N
• Initial Reporter State: KY
• Initial Reporter Country: US
• PMA/510(K) Number: 173834
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: distributor,foreign,health pr
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 07/27/2021

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: 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: Not provided
• Initial Report FDA Received Date: 08/23/2021
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Patient Age: 29 YR
• Patient Weight: 78