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

Model Number BO-HQV 129000

Device Problems Output Problem (3005); Pressure Problem (3012)

Patient Problems No Known Impact Or Consequence To Patient (2692); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/29/2021

Event Type  malfunction  

Manufacturer Narrative

A follow-up mdr will be submitted when further information becomes available.The sample has been requested but not received yet.

Event Description

Since the beginning of the ecc, the oxygenator module showed high delta pressure between inlet and outlet (500 mmhg in and 180 mmhg out).Shortly after the start (+/- 5 minutes), the whole circuit was replaced with a new one.Complaint # (b)(4).

Event Description

Complaint #: (b)(4).

Manufacturer Narrative

It was reported that the oxygenator module showed high delta pressure between inlet and outlet (500 mmhg in and 180 mmhg out) since the beginning of the ecc.Shortly after the start (+/- 5 min), the whole circuit was replaced with a new one.The product has been investigated in the laboratory of manufacturer on (b)(6) 2021.The visual inspection showed that there was no damage on the oxygenator.The leak test performed on blood side and water side also showed no abnormalities.Based on the test results, there is no indication of a cause for reported failure.Medical assessment was performed on (b)(6) 2021 by medical affairs.Considering the actual provided information the malfunction was not caused by the product or by user error.The event had no impact on the gas exchange of the product.However in reference to the risk assessment (quadrox-i small adult/adult, quadrox-id, dms #1464420 v17 ) the following events can contribute to clotting in the circuit: blockage of oxygenator; obstruction of filter; blockage of blood flow; inappropriate blood flow; air, particles, thrombogenicity in the circuit, at this point, the exact root cause of the event contained in this complaint is not able to be determined.Based on this the reported failure could not be confirmed.Device history record was reviewed on (b)(6) 2021.Following tests are performed according to the bop 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.According to the final test results, the oxygenator with the serial# (b)(6) passed the tests as per specifications.Production related influences can be excluded.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: OYGENATOR
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• MDR Report Key: 11320614
• MDR Text Key: 231563823
• Report Number: 8010762-2021-00105
• 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: 05/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/12/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/20/2022
• Device Model Number: BO-HQV 129000
• Device Catalogue Number: 70107.4294
• Device Lot Number: 92309905
• Date Manufacturer Received: 05/27/2021
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1