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

Model Number VKMO 71000

Device Problem Increase in Pressure (1491)

Patient Problems Insufficient Information (4580); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 05/20/2021

Event Type  Injury  

Manufacturer Narrative

The product has been requested but not received yet.The investigation is still ongoing.A follow up medwatch will be sent when further information becomes available.

Event Description

It was reported that there was a pressure increase in the oxygenator.The customer changed the oxygenator from another manufacturer.It was reported that there is a patient hazard however the outcome of which has not yet been clarified.Complaint #: (b)(4).

Manufacturer Narrative

It was reported that there was a pressure increase in the oxygenator.Customer changed the oxygenator from another manufacturer then works without any problems.It was reported that there is a patient hazard and further information was requested on (b)(6) 2021 for clarification.The user facility confirmed on (b)(6) 2021 that the patient had suffered neither damage nor restrictions after the incident (oxygenator change) - the postoperative course was normal.The product has been investigated on (b)(6) 2021 in the laboratory of manufacturer.Visual inspection and leak test were performed.The visual inspection of the complaint sample did not reveal any abnormalities with regard to damage to the oxygenator.The leak test also did not reveal any leak and product found tight according to test results.Additionally, no clots were detected.The complaint could not be confirmed based on test results.The affected product vkmo in this complaint id( b)(4) is a pack combination of an oxygenator and a reservoir.The device vkmo has no serial number however, the oxygenator in this pack has a unique serial number.The reported failure in this complaint concerns the component oxygenator in vkmo set.Therefore, production record review of the oxygenator -which has serial number on the device- is required.Device history record review of the complaint oxygenator was performed for the concerned lot and serial number.Device history record of the affected quadrox-i module (dms# 2977895, 2956698) were reviewed on 2021-07-19.Following steps are performed according to the basic operation procedure (bop) with a 100 % inspection: pressure test water and blood side tightness test gas and water side coating test final product test (visual inspection) according to the final test results, the oxygenator with the serial# (b)(6) passed the tests as per specifications.Production related influences are unlikely to have contributed to the reported failure.The medical review states, a root cause for the increase in pressure observed by the customer cannot be ascribed definitively to a product malfunction.Additionally, no conclusive root cause can be applied to either a complicating patient condition or to user handling for the same reason.Based on this information, the cause of the event could not be attributed to the device.However, the failure mode "pressure increase" can be linked to the following most possible root causes according to our risk management file (dms#1464420, v17): blockage of oxygenator, impaired blood flow, deteriorating gas transfer.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 #: (b)(4).

• Brand Name: OXYGENATOR
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• MDR Report Key: 11913881
• MDR Text Key: 253540378
• Report Number: 3008355164-2021-00016
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• PMA/PMN Number: K132829
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Distributor
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 08/18/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/01/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/27/2022
• Device Model Number: VKMO 71000
• Device Catalogue Number: 701067949
• Device Lot Number: 92305078
• Was Device Available for Evaluation?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 08/18/2021
• Distributor Facility Aware Date: 07/19/2021
• Device Age: 11 MO
• Event Location: Hospital
• Date Report to Manufacturer: 08/18/2021
• Date Manufacturer Received: 07/19/2021
• Patient Sequence Number: 1
• Patient Outcome(s): Other