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 08/03/2023

Event Type  malfunction  

Manufacturer Narrative

It was reported that blood leakage was occurred at the luer lock area of de-airing valve after 15 minutes of cpb operation started.After, the flow was approximately 5 l/min.90 minues after cpb started, the leakage became more and more, it was one drop every 5 seconds.No harm to any person has been reported.Additional information was received from customer as follow: there was not any leakage detected during priming.There was not any crack detected during visual controls.Customer connected a 3-way stopcock at luer lock connector.The sample investigation could not be performed since the sample could not be provided due to the chinese customs restrictions and regulations.However, a photograph was received from customer which shows the crack on luer lock connector of de-airing valve of oxygenator.Based on this, the complaint could be confirmed.The serial number on the oxygenator could not be provided.Therefore dhr (production records) review could not be performed for quadrox-i adult.The lot number of vkmo 71000 also could not be provided.The reported oxygenator lot number is 3000247485.Through the lot number 3000247485, the finished devices sold to china were identified via erp system (sap system).There are two lot numbers were identified: 3000257840, 3000257842.The production history records (dhrs) of the affected vkmo 71000 with lot# 3000257840, 3000257842 were reviewed on (b)(6) 2022.According to the dhr results, the product vkmo 71000 passed the defined manufacturing and final release specifications.There is no indication on manufacturing issues.Thus production related influences are unlikely.The reported failure was identified as part of current risk assessment and control of quadrox-i small adult/adult, quadrox-id adult and the most probable causes have been found as: manufacturing failure: material fatigue due to a weak point in the injection molded part.User failure: material fatigue due to excessive pressure peaks during priming / incorrect operation.User failure: material fatigue due to excessive torque when tightening the sample line.Stationary and transport conditions: mechanical damage of product during transportation due to vibration and impact.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

It was reported that blood leakage was occurred at the luer lock area of de-airing valve after 15 minutes of cpb operation started.After, the flow was approximately 5 l/min.90 minues after cpb started, the leakage became more and more, it was one drop every 5 seconds.No harm to any person was reported.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: 17539016
• MDR Text Key: 321048699
• Report Number: 8010762-2023-00393
• 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
• Report Date: 08/14/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/14/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: VKMO 71000
• Device Catalogue Number: 701067949
• Device Lot Number: UNKNOWN
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 08/04/2023
• Was Device Evaluated by Manufacturer?: No
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Outcome(s): Other