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

Model Number	Quantum Workstation (QWS)
Medical Device Problem Code	Labelling, Instructions for Use or Training Problem (1318)
Health Effect - Clinical Code	Insufficient Information (4580)
Date of Event	09/04/2020
Type of Reportable Event	Malfunction
Event or Problem Description
The clinician reported that a patient was on cpb, and noted that high line pressure was created from kink in the arterial line, max pressure was increased, high line pressure created again with a kink in the arterial line, max pressure servo regulated the pump to no flow, interlocked cardioplegia pump still running, created negative pressure in the arterial circuit, air was seen in the oxygenator and the arterial bubble detector shut off arterial pumps and dependent pumps.Patient was off cpb for 4 minutes while they deaired the system.Went back on cpb and finished the case.The system behaved as expected.The software logs revealed recommended steps were not followed.

• 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: 12656643
• Report Number: 3006073153-2020-00003
• Device Sequence Number: 4099575
• Product Code: DTQ
• UDI-Device Identifier: 05060434420008
• UDI-Public: 05060434420008
• Combination Product (Y/N): N
• Initial Reporter State: OH
• Initial Reporter Country: US
• PMA/510(K) Number: 173834
• Number of Events Summarized: 1
• Summary Report (Y/N): Y
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date (Section B): 09/29/2020

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: 09/04/2020
• 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: 4 YR