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

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

Device Problem Failure to Deliver (2338)

Patient Problems Death (1802); Thrombosis/Thrombus (4440)

Event Date 01/18/2021

Event Type  Death  

Manufacturer Narrative

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

Event Description

It was reported from a customer from thailand that during va ecmo after 20 minutes ecmo circuit have clot in the be-hmod 30000 oxygenator (pre-membrane).Result is flow drop (about 0.02 lpm), pressure p2 measure too high.Checked central cannulae a 10 fr., v 18 fr.Don't have clot and good position.Diagnosis tga, post operation aso , cpb time 300 min.Can't off cpb go to ecmo.Harm or death of patient or operator reported.The patient expired.Complaint id: (b)(4).

Manufacturer Narrative

It was reported from a customer from (b)(6) that during va ecmo after 20 minutes ecmo circuit have clot in the be-hmod 30000 oxygenator (pre-membrane).Result is flow drop (about 0.02 lpm), pressure p2 measure too high.Checked central cannulae a 10 fr., v 18 fr.Don't have clot and good position.Diagnosis tga, post operation aso , cpb time 300 min.Can't off cpb go to ecmo.Harm or death of patient or operator reported.The patient expired.The affected hmod 30000 with lot# 70144395 was requested for further investigation in the getinge laboratory.It was received on 2021-03-08 and during the technical investigation on 2021-03-15 the reported failure "clots in the oxygenator" could not be confirmed as the oxygenator was completely spilled out.To rule out a product malfunction a leak test was performed and no leakage was noted.For further investigation patient data was collected and a medical review was performed by getinge medical affairs specialist on (b)(6) 2021 with the following result: it follows from the details available in the complaint that the increase of the premembrane pressure (with low flow) was the response to clotting of the oxygenator.The clotting observed by the customer, however, was likely associated with the administration of protamine, ffp and platelets 10 minutes after the initiation of ecmo support.The instructions for use oxygenator quadrox-id pediatric | 1.6 | g-306 | 05 contained the following."the administration of coagulant protamine causes occlusion of the extracorporeal circulation and the patient circuit.This can lead to inadequate patient support, hemolysis or thrombus formation in the patient¿.The administration of protamine during extracorporeal support is strongly discouraged as its administration may lead to thrombus formation in either the patient and/or the extracorporeal circuit.The expiration of the patient appears to be the confluence of events including ¿massive¿ hemoptysis, the administration of procoagulants, the cessation of blood flow, and the inability of the patient to tolerate the combination of these circumstances.Further, the expiration of the patient does not appear to be directly associated with the oxygenator per se.A device history review (dhr) was performed and the dhr does not show any abnormality or issue that is related or can have led to the customer complaint.Based on the investigation results the reported failure "clots in the oxygenator" could be confirmed but no product related malfunction.The most probable root cause could be determined as a coagulation of the membrane caused by administration of protamine during extracorporeal support.The coagulation can lead to a blockage and thus an extension of the diffusion path lowering the oxygenating performance and decreasing the flow.The occurrence rate was calculated for the reported issue 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 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): NURSEL BOELENS; maquet cardiopulmonary ag; kehler strasse 31; rastatt 76437 ; GM 76437
• Manufacturer Contact: maquet cardiopulmonary ag; kehler strasse 31; rastatt 76437 ; 4972229321
• MDR Report Key: 11207146
• MDR Text Key: 227928314
• Report Number: 8010762-2021-00020
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: TH
• PMA/PMN Number: K132829
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,health profe
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/23/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/22/2022
• Device Model Number: BE-HMOD 30000#BE-QUADROX-ID PÄD.O.FILT.
• Device Catalogue Number: 701047041
• Device Lot Number: 70144395
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/08/2021
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/22/2021
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/23/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Death
• Patient Age: 20 DA
• Patient Weight: 4