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

Model Number QWS

Device Problems Mechanical Problem (1384); Infusion or Flow Problem (2964)

Patient Problem Low Cardiac Output (2501)

Event Date 07/16/2021

Event Type  malfunction  

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 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
• Type of Device: HEART LUNG MACHINE
• Manufacturer (Section D): SPECTRUM MEDICAL LTD; harrier4, meteor business park; cheltenham rd east; gloucester, GL2 9 QL,; UK GL2 9QL,
• Manufacturer Contact: samantha turnner ; harrier4, meteor business park; cheltenham road east; gloucester, gloucestershire GL2 9-QL ; UK GL2 9QL
• MDR Report Key: 12353161
• MDR Text Key: 269260733
• Report Number: 3006073153-2021-00008
• Device Sequence Number: 1
• Product Code: DTQ
• UDI-Device Identifier: 05060434422293
• UDI-Public: 5060434422293
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: 173834
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: distributor,foreign,health pr
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/27/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/23/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: QWS
• Device Catalogue Number: 51-000001-00
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Patient Age: 29 YR
• Patient Weight: 78