MAUDE Adverse Event Report: SPECTRUM MEDICAL LIMITED QUANTUM WORKSTATION 12" ELITE; CARDIOPULMONARY BYPASS MONITOR

Model Number QWS12E

Device Problem Insufficient Information (3190)

Patient Problem Air Embolism (1697)

Event Date 03/19/2024

Event Type  malfunction  

Event Description

Central line was broken and air was entrained down the venous line.It was reported that the air passed through the oxygenator, up the arterial line and past the flow/bubble sensor without alarming.The user reported that the bubble sensor was armed at the time of the event.

• Brand Name: QUANTUM WORKSTATION 12" ELITE
• Type of Device: CARDIOPULMONARY BYPASS MONITOR
• Manufacturer (Section D): SPECTRUM MEDICAL LIMITED; harrier4, meteor business park; cheltenham road east; gloucester, gloucestershire GL2 9 QL; UK GL2 9QL
• Manufacturer (Section G): SPECRTUM MEDICAL LIMITED; harrier4, meteor business park; cheltenham road east; gloucester, gloucestershire GL29Q L; UK GL29QL
• Manufacturer Contact: angus fletcher ; harrier4, meteor business park; cheltenham east road; gloucester, gloucestershire GL29Q-L ; UK GL29QL
• MDR Report Key: 19048623
• MDR Text Key: 339433742
• Report Number: 3006073153-2024-00004
• Device Sequence Number: 1
• Product Code: DRY
• UDI-Device Identifier: 05060434422309
• UDI-Public: 05060434422309
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,User Facility
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/04/2024

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?: Yes
• Device Model Number: QWS12E
• Device Catalogue Number: 51-000094-00
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 03/19/2024
• Initial Date FDA Received: 04/05/2024
• 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
• Treatment: QFS FLOW SENSOR51-000135-00FS4000340; QUANTUM VENTILATION MODULESL100164151-000109-00
• Patient Outcome(s): Required Intervention