MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY AG HLS SET; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number BEQ-HLS 7050 USA

Device Problem Output Problem (3005)

Patient Problem Insufficient Information (4580)

Event Date 02/13/2022

Event Type  malfunction  

Event Description

The patient was undergoing a decannulation from ecmo when the second set of tubing clamps pierced open the ecmo tubing.

• Brand Name: HLS SET
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY AG; 45 barbour pond drive; wayne NJ 07470
• MDR Report Key: 13653272
• MDR Text Key: 286464496
• Report Number: 13653272
• Device Sequence Number: 1
• Product Code: DTZ
• UDI-Device Identifier: 04058863080383
• UDI-Public: (01)04058863080383
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Risk Manager
• Type of Report: Initial
• Report Date: 02/16/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BEQ-HLS 7050 USA
• Device Catalogue Number: 701069078
• Is the Reporter a Health Professional?: No
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 02/16/2022
• Event Location: Hospital
• Date Report to Manufacturer: 03/02/2022
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Patient Age: 5475 DA
• Patient Sex: Female
• Patient Weight: 69 KG