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

Model Number QUADROX-I ADULT

Device Problem Coagulation in Device or Device Ingredient (1096)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 02/12/2020

Event Type  malfunction  

Manufacturer Narrative

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

Event Description

''oxy was blocked during the operation.There was no patient harm.I already have the oxy and the perfusion protocol.Lot oxy is requested''.(b)(4).

Manufacturer Narrative

The sample was requested for the technical investigation and it was received on 05.03.2020.During the investigation, a leak at the luer lock on the blood outlet side was found.Since the leak in the luer lock part was not reported by the customer, it can be concluded that the damage that caused this leak may have occurred during the transportation of the sample to the laboratory.No clots or another abnormality were detected.The failure regarding the clotting could not be confirmed.In addition the device history record for complaint (b)(4) and lot 70130097 and 92263001 have been reviewed.There are no evidences indicating a non conformance or deviations of the product in question during the manufacturing and final release of this specific lot.Trend search was performed and no systemic issue could be found.The reported failure was identified as part of the current risk management file (dms #(b)(4)).Mitigations for this specific failure are in place in instruction for use.Mitigations: ifu: no anticoagulation or insufficient anticoagulation causes occlusion of the extra corporeal circulation and the patient circuit.This can lead to inadequate patient support, hemolysis or thrombus formation in the patient.¿ weigh the benefits of extracorporeal circulation against the risk of systemic anticoagulation.¿ use anticoagulants; e.G.Heparin or argatroban.¿ check the effect of anticoagulants at regular intervals by measuring the act(activated clotting time).The act should not fall below 480 s.According to the ifu, it is the user's responsibility to ensure that the act level does not fall below 480.However, according to the information received, act level was observed to be 420.Moreover, the available information has been shared internally with getinge therapy application manager.It was stated that: the gas transfer rate was low during the end of the application, when the patient was rewarmed.The last act was 420sec.Therefore it is possible that the diffusion path became longer because of a fibrin layer on the gas fiber.The probable root cause is an insufficient anticoagulation.Since there are no evidences indicating a non conformance or deviations of the product in question , the failure could not be confirmed.The reported failure did not contribute to death or serious injury.At this time it cannot be concluded that this is a systemic error.Thus, no remedial action is required.No corrective action is needed.This complaint is being monitored as part of the complaint data trending of maquet cardiopulmonary gmbh and further investigations and measures will be conducted in case of adverse trending.

Event Description

Complaint: (b)(4).

• Brand Name: OXYGENATORS
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• MDR Report Key: 9788143
• MDR Text Key: 190539402
• Report Number: 8010762-2020-00087
• 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: 02/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/04/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 06/14/2021
• Device Model Number: QUADROX-I ADULT
• Device Catalogue Number: 70107.0061
• Device Lot Number: 92263001
• Date Manufacturer Received: 06/01/2020
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1