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

Model Number BO-VKMO 51000

Device Problem Leak/Splash (1354)

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

Event Date 06/03/2022

Event Type  malfunction  

Event Description

It was reported that blood leakage was occurred on gas outlet of oxygenator during treatment.Customer did not change the product since leakage was occurred just before the withdrawal of extracorporeal circulation.Operation was completed without any problem and patient was not affected.

Manufacturer Narrative

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

Event Description

#(b)(4).

Manufacturer Narrative

It was reported that blood leakage was occurred on gas outlet of oxygenator during treatment.Customer did not change the product since leakage was occurred just before the withdrawal of extracorporeal circulation.Operation was completed without any problem and patient was not affected.No harm to any person has been reported.The sample was investigated at getinge laboratory.Visual control was performed and there could not found external damage on the product.Leak test was performed for 6 hours and there was not any leakage occurred on blood side.Tightness test was also performed for water side and gas side and there could not be found any abnormalities.No abnormalities were found during the flow test.According to the test results, the reported failure could not be reproduced during laboratory investigation, technical cause of the failure could not be determined.Based on the test results, failure could not be confirmed.The production records of the affected oxygenator were reviewed on 2022-08-25.Following tests are performed according to the bop as a 100 % inspection: ¿ leak test after welding ; ¿ pressure test heat exchanger; ¿ leak test water side ; ¿ leak and flow test gas side ; ¿ pressure test blood side ; ¿ coating test.According to the final test results, the oxygenator with the serial# 1773269 passed the test as per specifications.Production related influences can be excluded.The production history records (dhrs) of the affected bo-vkmo 51000 with lot# 3000164569 was reviewed on 2022-06-10.According to the dhr result, the product bo-vkmo 51000 passed the defined manufacturing and final release specifications.There is no indication on manufacturing issues.Thus production related influences are unlikely.The failure could be linked to the risk assessment file of quadrox-i small adult/adult, quadrox-id adult and probable cause could be: -lack of information - vapor permeation while normothermic water within the water compartment is interacting with un-heated medical gas / oxygen within gas exchange compartment user identifies condensation as "leakage".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.

• Brand Name: OXYGENATOR
• 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: 14642070
• MDR Text Key: 293692343
• Report Number: 8010762-2022-00211
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: JA
• PMA/PMN Number: K132829
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 08/26/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/14/2023
• Device Model Number: BO-VKMO 51000
• Device Catalogue Number: 701068197
• Device Lot Number: 3000164569
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/16/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 04/14/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Sex: Prefer Not To Disclose