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

Model Number BE-HLS 7050 #SHLS SET ADVANCED 7.0

Device Problem Leak/Splash (1354)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Date 02/21/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that there was a leakage on the gas outlet and the hls set was not exchanged.The failure occurred during treatment.No harm to any person has been reported.Complaint id# (b)(4).

Manufacturer Narrative

It was reported that there was a leakage on the gas outlet and the hls set was not exchanged.The failure occurred during treatment.The affected hls set was investigated in the getinge laboratory on (b)(6) 2023 with following conclusion: a leak test was performed at the water, gas and blood side of the product.On the blood side of the oxygenator a leak could be determined at the emergency gas outlet during the leakage test.During the investigation, a leak between the blood and gas side of the oxygenator could be confirmed.The exact root cause remains unknown.However the most probable root cause of the failure could be: insufficient pur (polyurethan) encapsulation of the mat package.Fiber detachment in the pur encapsulation.Fiber damage.Based on the investigation results the reported failure "leakage at the gas outlet connector" could be confirmed.The exact root cause remains unknown.According to our risk review the reported failure corresponds to an occurrence rate 2, which is below the acceptance threshold according to our risk management plan.Getinge is monitoring incoming complaints for the reported failure on an ongoing basis.Thus further actions will be performed in case of adverse trending of the reported failure.The occurrence rate was calculated for the reported failure and product 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
• 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: 16465819
• MDR Text Key: 310497396
• Report Number: 8010762-2023-00115
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: FR
• PMA/PMN Number: K112360
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Health Professional,User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/19/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/02/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 03/04/2023
• Device Model Number: BE-HLS 7050 #SHLS SET ADVANCED 7.0
• Device Catalogue Number: 701069073
• Device Lot Number: 300225885
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 06/12/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 03/04/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1