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

Model Number HQV 3900#

Device Problem Output Problem (3005)

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

Event Date 07/19/2023

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

It was reported that: "during preparation for an emergency case all the routine safety checks were done, including gas hoses connected and gas loss alarm working, o2 analyser calibrated and working, gas flow check, and cdi po2 correlated with fio2 set at the gas blender.Patient was stable during cannulation, went onto cpb with an fio2 60% and a gas flow of 3.2 l/min.The total patient flow was 5.2 l/min and the first hb on cpb 10.8 g/dl.At initiation of cpb all the usual checks were performed, there was colour change between arterial and venous lines, therefore full flow was announced and lungs were turned off.At that point the perfusionist realised that despite the colour change being present the blood in the lines was a bit darker than expected, at that point the cdi po2 was around 11kpa an pco2 of 7kpa (at this point patient's temperature was 34 degrees c), the anaesthetist was requested to ventilate the patient again and heart was filled by putting a partial clamp in the venous line to fill the heart, the po2 in the cdi increased to 20's.The team was informed about the problem, gas line and flow were thoroughly double checked by 2nd perfusionist, o2 analyser was working reading around 60%.When the checks were finished and both perfusionist were happy that the blender and the gas flow was fine the lungs were turn off again with consequent drop in the cdi po2 to 15 kpa, this was verified by a post oxygenator blood gas.Then lungs were turn on again, sweep and fio2 increased on the cpb blender.After a discussion with mdt was decided to increase the fio2 to 90% and turn off the lungs again, po2 took several minutes but increased to 47kpa.It was decided by the team to carry on the case with the same oxygenator and have a ready stand by cpb available in case of total oxygenator failure.The case carried on with higher blender settings than it is expected with the same oxygenator, but otherwise uneventful." no harm to any person was reported.Complaint #: (b)(4).

Manufacturer Narrative

The perfusionist realised that despite the colour change being present the blood in the lines was a bit darker than expected.It was decided by the team to carry on the case with the same oxygenator and have a ready stand by cpb available in case of total oxygenator failure.The case carried on with higher blender settings than it is expected with the same oxygenator.No harm to any person was reported.The product was investigated in the laboratory of getinge on 2023-09-04.The product quadrox-i adult was received with no damages.The product was applied to pressure test, leak test and visual test.As a result, all test runs have passed.As per the test results, there is no indication of any technical cause behind the insufficient oxygenation.Technically, the sample is in a fully functional state.The failure could not be confirmed.The production history record (dhr) of the affected hqv 3900# with lot # 3000287143 was reviewed on 2023-08-09.According to the dhr results, the product hqv 3900# passed the defined manufacturing and final release specifications.There is no indication on manufacturing issues.Thus production related influences are unlikely.The production records of the affected oxygenator (material#: 701067789; udi#: (b)(4)) were reviewed on 2023-09-01.Following tests are performed according to the bop (basic operation procedure) 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 udi#: (b)(4) passed the test as per specifications.Production related influences can be excluded.The reported failure could be linked to the current risk management file and the most probable causes are associated to: exceeding intended duration use clotting, diffusion path too long.Cleanliness level of gas.The user didn¿´t perceived or recognized how to recirculate the blood after ending of perfusion.Perfusion was started because the patient needs additional extracorporeal circulation support.Act is below 480 seconds clotting.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
• Manufacturer (Section G): JULIA KAPFENBERGER; neue rottenburger strasse 37; hechingen
• Manufacturer Contact: neue rottenburger strasse 37; hechingen
• MDR Report Key: 17456890
• MDR Text Key: 320417234
• Report Number: 8010762-2023-00376
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: UK
• PMA/PMN Number: K132829
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 09/20/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HQV 3900#
• Device Catalogue Number: 701053616
• Device Lot Number: 3000287143
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/04/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 12/20/2022
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1