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 03/14/2022

Event Type  malfunction  

Event Description

It was reported that leakage was occurred on air tap (pre/post filter) on the oxygenator during operation.The cock position was changed and no leakage was occurred after change.The operation completed without any complications and there is not any problem with patient health.

Manufacturer Narrative

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

Manufacturer Narrative

It was reported that leakage was occurred on air tap (pre/post filter) on the oxygenator during priming and customer decided to stop leakage by changing de-airing valve location to closed.The tap position was changed and no leakage was occurred after change.The operation completed without any complications and there is not any problem with patient health.Customer did not need to change the product.Since the product was discarded by customer, sample investigation could not be performed.However, the received video shows that leakage was occurred at de-airing valve when the valve is on position 1 (de-airing down stream of arterial filter).Based on this, failure could be confirmed.The serial number of oxygenator and the lot number of the vkmo 71000 could not be provided by the customer.Manufacturer identified the finished devices sold to germany were identified via an erp system (sap).The production history records (dhrs) of the affected vkmo 71000 with lot# 3000202254, 3000202256 and 3000202255 were reviewed on 2022-03-23.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.Based on the information obtained in this investigation, the reported failure could be linked to the risk assessment and control quadrox-i small adult / adult (dms#1464420, v19) and the most probable cause could be: - use errors: application of damaged device / lack of information on damaged device.- use errors: lack of attention on device handling.- mechanical damage of the device during transportation ¿ lack of information on damaged device.The user error related risks are covered in instruction for use (ifu) of quadrox-i small adult / adult: "warning! oxygenator leaks and damage.Can lead to infections, blood loss and embolisms in the patient.¿ before priming the oxygenator, run water through the heat exchanger and check for leaks on the blood side while priming.¿ check the oxygenator for leaks on the blood-carrying side while priming.¿ do not use the oxygenator if there are any leaks.".The customer will be informed about the results via sales and service unit germany.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 : sample was discarded by user.

Event Description

(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: 13861033
• MDR Text Key: 288200408
• Report Number: 8010762-2022-00098
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: GM
• 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: 04/22/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/23/2022
• 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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 04/01/2022
• Was Device Evaluated by Manufacturer?: No
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Age: 46 YR
• Patient Sex: Female
• Patient Weight: 54 KG