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

Model Number BO-HQV 129001

Device Problem Pressure Problem (3012)

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

Event Date 06/15/2021

Event Type  malfunction  

Manufacturer Narrative

Investigation is still ongoing.A follow up medwatch will be submitted when further information becomes available.

Event Description

It was reported that there was pressure increase at inlet of oxygenator while the outlet pressure remains constant.It was detected during ecc.It was decided about half an hour after entering the ecc, to add oxygenator in parallel to reduce the pressure.No indication of actual harm or death was reported.Complaint: #(b)(4).

Event Description

Complaint #: (b)(4).

Manufacturer Narrative

It was reported that there was pressure increase at inlet of oxygenator while the outlet pressure remains constant.It was detected during operation and decided to add another oxygenator in parallel to reduce the pressure.The product was received back and investigated in the laboratory.During leakage test of the blood and water side of the oxygenator no deficiency was found.Also, no pressure drop could be observed.All tests passed.Based on this the reported failure 'pressure increase at inlet of oxygenator' could not be confirmed.The device history record was reviewed.There is no indication that manufacturing issues occurred, thus production related influences are unlikely to have contributed to the reported failure.Based on the perfusion protocol a medical assessment was performed by getinge affairs and the following cause could have led to the event described by the customer: 1.The act may not have been of sufficient level to prevent clotting began the oxygenator when coupled with the function of at iii.Internal clotting of the oxygenator may explain the increase in the inlet pressure.As the product arrived in a pre-cleaned status in our investigation laboratory this could not be determined, but also not ruled out.2.As it is reported that the temperature was 32,5c° it is possible that the patient had cold agglutination cells that contributed to clotting inside the oxygenator what would explain the increase of the inlet pressure.As the product arrived in a pre-cleaned status in our investigation laboratory, this could not be determined, but also may not be ruled out.Cold agglutinins (ca) circulate as autoantibodies present in most humans.They are active below normal body temperatures.Cold hemagglutinin disease involves the presence of ca sufficiently active at temperatures in the periphery to produce hemolysis or agglutination.Systemic hypothermia and cold cardioplegia may result in agglutination or hemolysis.3.At iii substitution is indicated in patients with inherited antithrombin iii deficiency if they suffer acute thrombosis and if they have to be treated surgically.In acquired antithrombin iii deficiency, at iii substitution/addition may be necessary if thrombotic complications occur.At iii substitution has been promoted, specifically, in patients with polytrauma, septicaemia, dic, acute liver failure and in toxaemia.As in this case, at iii was administered, it could be possible that clot formation was already present and the at iii administration did not influence thrombotic development.4.The existence of a pressure excursion (secondary to platelets adhesion) may also explain the observation cited by the customer.As a result, the exact root cause could not be determined exactly however according to the investigation results product related malfunctions could be ruled out.The most probable cause of the issue is could be determined as patient related.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.

• Brand Name: TUBING SET
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• MDR Report Key: 12119785
• MDR Text Key: 259977688
• Report Number: 8010762-2021-00374
• 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: Manufacturer
• Source Type: company representative,health
• Type of Report: Initial,Followup
• Report Date: 11/01/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BO-HQV 129001
• Device Catalogue Number: 70107.4297
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 07/29/2021
• Initial Date Manufacturer Received: 06/17/2021
• Initial Date FDA Received: 07/06/2021
• Supplement Dates Manufacturer Received: 10/20/2021
• Supplement Dates FDA Received: 11/03/2021
• Patient Sequence Number: 1