MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH QUADROX-ID PEDIATRIC DIFFUSION MEMBRANE OXYGENATOR WITH BIOLINE COATING; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number BE-HMOD 30000#BE-QUADROX-ID PÄD.O.FILT.

Device Problem Coagulation in Device or Device Ingredient (1096)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 05/05/2020

Event Type  malfunction  

Event Description

Development of film on arterial side within first 48hrs of use ((b)(6) 2020)- film appears to cover exactly ½ front screen.(b)(4).

Manufacturer Narrative

The device history record was reviewed on 2020-06-22.There were no references found, which are indicating a nonconformance of the product in question.The oxygenator was investigated in the laboratory on 2020-06-09.Results of laboratory investigation: during visual inspection no defects, damage and/or foreign bodies on the oxygenator (e.G.Cracks, ridges) could be detected.On the blood inlet side (venous side) a slightly clotting was found.On the blood outlet side (arterial side) the clotting was stronger and a protein-like substance (fibrin) covering half of the arterial side of the oxygenator was detected.A ct scan of the oxygenator shows no abnormalities, e.G.Damage and/or foreign bodies, which could promote blood clotting.In addition a ct scan of two other oxygenators with the same issue was performed and no defects were found.A medical review was performed by manager medical affairs on 2020-08-19.Results of medical review: as stated in the report, the customer observed the formation of a milky-white clot in the be-hmod 30000 post-chamber (arterial side) a number of days after initiating extracorporeal support using the product.While the user(s) indicated that a number of clinical parameters showed little to no deviation from the institution¿s clinical practice and/or protocol, some points are of particular interest with respect to this report: -it was mentioned that protamine was administered during extracorporeal support to reduce the activated clotting time (act) from 400 seconds to 200 seconds.While this does not appear to be a clinical regularity for this institution, it may have been a precipitating event, resulting in the observation cited by the customer in at least one case.-normal antithrombin iii (atiii) levels for children are between 60-90%.The complaint report mentioned that the atiii levels were maintained at 21% to reduce the bleeding experienced by the patient.A study in 2014 held atiii levels at 70% of normal for patients on ecmo using supplementation.-an average activated partial thromboplastin time (aptt) of 42 seconds was stated by the customer.The usual therapeutic target for aptt is 1.5 ¿ 2.5x (60-80 seconds) the normal aptt with heparin.-according to the customer transexamic acid was administered to a patient in one case.Transexamic acid is a known antifibrinolitic and is usually administered to manage a defined coagulopathy.-last, while the administration of blood products during ecmo are frequently necessary, blood products containing procoagulative elements (e.G.Platelets) may serve to accelerate the coagulation cascade, resulting in unexpected results in the extracorporeal circuit.Any one, or a combination, of the above mentioned points may have contributed to the phenomenon observed in the context of this complaint.Thus the issue could be confirmed but it was no product related malfunction.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.Note: until today (2020-09-10), 13 complaints from the hospital ((b)(6)) were received for the same failure.In all cases no product related malfunction could be confirmed.

Event Description

Complaint id: (b)(4).

• Brand Name: QUADROX-ID PEDIATRIC DIFFUSION MEMBRANE OXYGENATOR WITH BIOLINE COATING
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• MDR Report Key: 10044196
• MDR Text Key: 190537046
• Report Number: 8010762-2020-00156
• 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: foreign,health professional,o
• Type of Report: Initial,Followup
• Report Date: 09/10/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/11/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2021
• Device Model Number: BE-HMOD 30000#BE-QUADROX-ID PÄD.O.FILT.
• Device Catalogue Number: 70104.7041
• Device Lot Number: 70130804
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/19/2020
• Date Manufacturer Received: 08/19/2020
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1