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

Model Number VKMO 71000

Device Problem Leak/Splash (1354)

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

Event Date 10/24/2023

Event Type  malfunction  

Event Description

It was reported that leakage was occurred at the dialysis lock with valve of oxygenator after 15 minutes of cpb operation started.No harm to patient occurred.Customer changed the product with new one.Complaint #(b)(4).

Manufacturer Narrative

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

Manufacturer Narrative

It was reported that leakage was occurred at the dialysis lock with valve of oxygenator after 15 minutes of cpb operation started.No harm to patient occurred.Customer changed the product with new one.No harm to any person has been reported.Sample investigation could not be performed since the product could not be provided due to china customs regulations.However, a photograph is provided which shows the reported failure ¿leakage at dialysis lock with valve¿.Based on this, failure could be confirmed.The serial number on the oxygenator could not be provided.Therefore dhr review could not be performed for quadrox.The production history records (dhrs) of the affected vkmo 71000 with lot# 3000318959 was reviewed on 2023-11-14.According to the dhr results, the product vkmo 71000 passed the defined manufacturing and final release specifications.The exact root cause could not be determined however the reported failure could be linked to the risk assessment file of product and the probable causes could be: - manufacturing: assembly failure of the o-ring inside the dialysis lock with valve.- user: lack of attention on device handling.These root causes could not be confirmed.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.H3 other text : 4115.

Event Description

Complaint # (b)(4).

• 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: 18017660
• MDR Text Key: 327069094
• Report Number: 8010762-2023-00526
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: CH
• 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: 11/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/27/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 05/26/2023
• Device Model Number: VKMO 71000
• Device Catalogue Number: 701067949
• Device Lot Number: 3000318959
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/14/2023
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Other