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).

Event Description

Complaint id: (b)(4).

Manufacturer Narrative

It was reported that the hls pump made unusual noises during patient treatment.After treatment the hls set was disposed by the customer, thus no technical investigation was possible.For further investigation a medical review was performed by getinge medical experts on (b)(6) 2021 with following results: as the family of the patient decided to end the therapy, the expiration of the patient could not attributed to the product.As stated by the customer no change in flow or pressure was noticed.One possible explanation for the mentioned noise could be the presence of a clot in the oxygenator which may have elicited the noise described by the customer.Additionally, covid-19 patients tend to be coagulopathic (viz.Thrombogenic) which may have led to clot deposition on the rotor of the cardiohelp internal pump.Following additional probable root causes are listed in the risk assessment file of the hls set: increase of gaps between rotor and pump housing; decoupling of rotor; rapture of rack.The production records of the affected hls module (dms# 3017363, 3036824) were reviewed on (b)(6) 2021.According to the final test results, all oxygenators passed the tests as per specifications.Production related influences can be excluded.Based on the investigation results the reported failure "unusual noise" could not be confirmed.Further the death of patient could not be attributed to the reported failure and product.The occurrence rate was calculated for the reported failure and it was determined that this is not a systemic issue.Therefore, no remedial action is required.The occurrence rate related to the reported issue is currently being monitored as part of maquet cardiopulmonary¿ s trending program and additional investigations or corrections will be implemented in case of adverse trending.

• Brand Name: HLS SET ADVANCED
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; 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
• 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: Health Professional
• Device Model Number: BEQ-HLS 7050 USA#HLS SET ADVANCED 7.0
• Device Catalogue Number: 701052794
• Was Device Available for Evaluation?: No
• 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
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Death