MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH HLS SET ADVANCED 7.0; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number BE-HLS 7050 #SHLS SET ADVANCED 7.0

Device Problem No Flow (2991)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/22/2020

Event Type  Injury  

Manufacturer Narrative

The affected product was requested for return.The investigation is pending.

Event Description

45 min after initate ecls-therapy blood clotted in the oxygenator, system stopped and because the circulation of the patient was completely dependent from the cardiohelp-system, heart lungs resuscitation was needed during the time of hls-system change.Heart lungs resuscitation was successful, at the moment no patient damage is expected.(b)(4).

Manufacturer Narrative

A follow-up emdr will be submitted when additional information becomes available.

Event Description

Complaint id: (b)(4).

Event Description

Complaint id: (b)(4).

Manufacturer Narrative

Type of reportable event corrected to serious injury.The production records of the hls module were reviewed and according to the final test results, the oxygenator with the serial# (b)(6) passed the test as per specifications.Production related influences can be excluded.The hls set was investigated in the laboratory on 2021-01-30: during visual inspection no abnormalities were detected.A leak test of the water and blood side was performed which revealed no leakages.Further the pump was tested and no issue were noted.No technical causes for the development of blood clots were found.For further investigation as medical assessment was performed by manager medical affairs with following results: protamin was administered after cpb but neither the dose nor the mode of administration are known.It is also not known if additional protamin was administered when coagulation testing after application of protamin still showed an act of 243 seconds.Essential data such as information on the administration of blood products and/or coagulation factors have not been provided.Act measurements were not performed at the time of ecls start, during the 45 minute period on ecls, at the time when clotting of the oxygenator and a decrease in blood flow were noticed, or at the time when the device was replaced and ecls therapy was started with a new device.No information has been provided on the status/system parameters of the cardiohelp system during the 45 minute period of ecls.The information available does not allow identification of a reason for clotting.Following possible root causes could lead to the reported failure: insufficient anticoagulation.Substitution of blood products.Patient pre condition.Based on the investigation results no malfunction of the product could be confirmed.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.

Manufacturer Narrative

The production records of the hls module were reviewed and according to the final test results, the oxygenator with the serial# 1636186 passed the test as per specifications.Production related influences can be excluded.The hls set was investigated in the laboratory on 2021-01-30: during visual inspection no abnormalities were detected.A leak test of the water and blood side was performed which revealed no leakages.Further the pump was tested and no issue were noted.No technical causes for the development of blood clots were found.For further investigation as medical assessment was performed by manager medical affairs with following results: protamin was administered after cpb but neither the dose nor the mode of administration are known.It is also not known if additional protamin was administered when coagulation testing after application of protamin still showed an act of 243 seconds.Essential data such as information on the administration of blood products and/or coagulation factors have not been provided.Act measurements were not performed at the time of ecls start, during the 45 minute period on ecls, at the time when clotting of the oxygenator and a decrease in blood flow were noticed, or at the time when the device was replaced and ecls therapy was started with a new device.No information has been provided on the status/system parameters of the cardiohelp system during the 45 minute period of ecls.The information available does not allow identification of a reason for clotting.Following possible root causes could lead to the reported failure: - insufficient anticoagulation - substitution of blood products - patient pre condition based on the investigation results no malfunction of the product could be confirmed.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.

Event Description

Complaint id: (b)(4).

• Brand Name: HLS SET ADVANCED 7.0
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• MDR Report Key: 10784203
• MDR Text Key: 214560312
• Report Number: 8010762-2020-00373
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• PMA/PMN Number: K112360
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,health profe
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 02/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/04/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BE-HLS 7050 #SHLS SET ADVANCED 7.0
• Device Catalogue Number: 701069073
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/12/2020
• Date Manufacturer Received: 01/30/2021
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention