MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH HLS SET ADVANCED OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number BEQ-HLS 7050 USA#HLS SET ADVANCED 7.0

Device Problem Noise, Audible (3273)

Patient Problem Death (1802)

Event Date 02/11/2021

Event Type  Death  

Manufacturer Narrative

Further information (patient data, perfusion protocol) were requested from the customer and are still pending. A follow-up emdr will be submitted when additional information becomes available.

Event Description

The customer reported that they had a covid-ecmo patient that has been on the same circuit for 45 days and the last couple days the hls set has been making a whine sound and has gotten louder. On (b)(6) 2021 it was reported that the family of the patient decided that the therapy was discontinued due to no progress of improvement over the 68 days of treatment. Patient expired. Complaint id: (b)(4).

• Brand Name: HLS SET ADVANCED
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• Manufacturer (Section G): JULIA KAPFENBERGER; neue rottenburger strasse 37; hechingen
• Manufacturer Contact: neue rottenburger strasse 37; hechingen
• MDR Report Key: 11338840
• MDR Text Key: 232221366
• Report Number: 3008355164-2021-00003
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 04/14/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes

Device Operator

• Device Model Number: BEQ-HLS 7050 USA#HLS SET ADVANCED 7.0
• Device Catalogue Number: 701052794
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 04/14/2021
• Distributor Facility Aware Date: 03/25/2021
• Event Location: Hospital
• Date Report to Manufacturer: 04/14/2021
• Date Manufacturer Received: 03/25/2021
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: Yes

Type of Device Usage

Patient Treatment Data

Date Received: 02/17/2021 Patient Sequence Number: 1