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

Model Number BE-HLS 7050 #SHLS SET ADVANCED 7.0

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problem Cardiac Arrest (1762)

Event Date 08/09/2022

Event Type  Death  

Event Description

The event occurred in spain.It was reported that upon entering ecmo with an hls set the patient presented progressive hypotension and cardiorespiratory arrest due to pulseless electrical activity.By checking the arterial cannula, bleeding and increased abdominal and inguinal perimeter suggestive of intra-abdominal-retroperitoneal was noticed.The patient expired.Complaint id: (b)(4).

Manufacturer Narrative

The investigation is ongoing.Further information has been requested but has not yet been received.A follow-up emdr will be submitted when additional information becomes available.

Manufacturer Narrative

It was reported that upon entering ecmo with an hls set the patient presented progressive hypotension and cardiorespiratory arrest due to pulseless electrical activity.By checking the arterial cannula, bleeding and increased abdominal and inguinal perimeter suggestive of intra-abdominal-retroperitoneal was noticed.The patient expired.The customer also reported that the death of this patient has been produced mainly due to a complication happening during the process of cannulation, not by the ecmo system itself.He further noticed that this is a pilot of the national registry renacer (developed by aemps) which was recently launched with the aims to identify complications in the very complex ecmo clinical scenario.Efforts were performed towards customer to retrieve adequate information but customer confirmed that this complaint was closed from hospital side and no more information will become available.In addition, the hls set was not available for technical investigation of the manufacturer.Thus the exact root cause of the reported event could not be determined.A medical review was performed by getinge medical affairs on 2022-10-20 with the following outcome: based on the described event, it can be determined that the patient's expiration cannot be linked to the hls set or to the ecmo system (i.E.Cardiohelp system).As explained in the complaint narrative, intra-abdominal/retroperitoneal bleeding as well as pre-cannula bleeding contributed to progressive hypotension and cardiorespiratory arrest because of complications during cannulation.It was also stated by the adult ecmo program director that, ¿the death of this patient has been produced mainly due to a complication happening during the process of cannulation, not by the ecmo system itself¿.As a note, the ¿ecmo system¿ is assumed to be the getinge cardiohelp system as the hls set advanced was used as the disposable.The production records of the affected be-015703112 #shls module advanced adult with packaging lot#3000205817 and lot#3000206471 were reviewed on 2022-10-25.According to the final test results, all hls module with lot#3000205817 and lot#3000206471 passed the tests as per specifications.Production related influences are unlikely.Based on the investigation results a failure of the hls set could not be confirmed.The occurrence rate was calculated for the reported issue 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.H3 other text : 4115.

Event Description

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: 15361387
• MDR Text Key: 299277989
• Report Number: 3008355164-2022-00027
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: K112360
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: Foreign,Consumer,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 11/02/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 12/10/2022
• Device Model Number: BE-HLS 7050 #SHLS SET ADVANCED 7.0
• Device Catalogue Number: 701069073
• Device Lot Number: 3000210638
• 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: 11/02/2022
• Distributor Facility Aware Date: 10/20/2022
• Device Age: 9 MO
• Event Location: Hospital
• Date Report to Manufacturer: 11/02/2022
• Date Manufacturer Received: 10/20/2022
• Was Device Evaluated by Manufacturer?: No
• Date Device Manufactured: 12/10/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death