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

Model Number QUADROX-ID PEDIATRIC

Device Problem Coagulation in Device or Device Ingredient (1096)

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

Event Date 01/18/2022

Event Type  malfunction  

Manufacturer Narrative

It was reported that a yellowing film was noted on the arterial side of a quadrox-id pediatric and the oxygenator failed, and had to be replaced.No harm to the patient was reported.The affected oxygenator was discarded by the customer.Therefore no laboratory investigation could be performed.However the reported failure was evaluated from getinge medical experts in a previously complaint with the following outcome: plasma leakage from hollow fiber oxygenators and in diffusion membranes has been extensively reported in the literature and is particular common during long term support and in association with extracorporeal membrane oxygenation.The variables that have been identified to potentiate plasma leakage include the presence of endogenous (excess lipoproteins, or cholesterol) or exogenous (alcohol, or drugs).These surface acting species in the patient¿s blood may strongly and rapidly modify the hydrophobic character and the intrinsic resistance to plasma breakthrough.Authors have also reported i) the duration of application, ii) the administration of pharmacological agents (propafol infusion or agents with a high lipid load), iii) various disease states that alter the total protein component of the blood (and iv) as a result of hyperbilirubinemia.Various cautions and warnings during application are noted in the instructions for use.The hydrophobic de-airing filter integrated into the oxygenator functions as part of the de-airing port process during priming.It can undergo ¿plasma wetting¿ when in contact with blood.The most likely cause is related to bi-polar phospholipids in blood adhering to the surface of the filter.The hydrophobic filter is thus coated with a hydrophilic layer on the filter surface, degrading performance and creating pathways for plasma diffusion and the observed leakage.This change in filter performance has been referred to as a loss of hydrophobicity.The production records of the affected oxygenator and all related documents were reviewed on 2022-02-01.Following tests are performed according to the bop as a 100 % inspection: pressure test, tightness test, final product test.According to the final test results, all oxygenators passed the tests as per specifications.Production related influences are unlikely to have contributed to the reported failure.Based on the investigation results and the given information the reported failure could not be confirmed.The occurrence rate was calculated for the reported failure 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

It was reported that a yellowing film was noted on the arterial side of a quadrox-id pediatric and the oxygenator failed, and had to be replaced.No harm to the patient was reported.Complaint id #(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: 13417063
• MDR Text Key: 284960314
• Report Number: 8010762-2022-00028
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K132829
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 02/01/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/01/2022
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 10/13/2022
• Device Model Number: QUADROX-ID PEDIATRIC
• Device Catalogue Number: 701070397
• Device Lot Number: 3000198411
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/20/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 10/13/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1