MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH QUADROX-ID PÄD; OXYGENATOR, CARDIOPULMONARY BYPASS

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

Device Problem Insufficient Flow or Under Infusion (2182)

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

Event Date 08/13/2021

Event Type  malfunction  

Manufacturer Narrative

Further patient data and perfusion protocol were requested but not yet received.A follow-up emdr will be submitted when additional information becomes available.

Event Description

The customer reported that the oxygenator clotted and the oxygenation decreased during treatment.No harm to patient reported.Complaint id: (b)(4).

Event Description

Complaint id: (b)(4).

Manufacturer Narrative

It was reported that a quadrox-id pedi was clotting during treatment and the oxygenation decreased.The affected quadrox-id pedi was technically investigated in the getinge laboratory on (b)(6) 2022.A leakage at the blood inlet connector was found.It could be determined that the leak was caused by a crack.The leakage could be a cause of the clots.However, it is possible that the tear has been arisen afterwards.Additionally, the customer did not report a leak on the inlet connector of the oxygenator.The production records of the affected quadrox-id pedi module were reviewed on (b)(6) 2022.According to the final test results, the oxygenator with the serial# (b)(6) passed the tests as per specifications.Production related influences are unlikely to have contributed to the reported failure.For further investigation a medical assessment was performed by getinge medical experts on 2022-02-22.In absence of more details of how this scenario could have contributed to the event described by the customer, the most likely root cause of clotting may have been associated with insufficient anticoagulation.The management of a patient on ecls is the same as for any critically ill patient with the added need for anticoagulation to maintain patency of the extracorporeal circuit without causing bleeding within the patient and thrombosis within the circuitry or the patient.Most thrombo-embolic complications occur despite values of conventional coagulation tests being within the targeted range.Unexpected clotting may be due to conventional coagulation tests such as international normalised ratio (inr), activated partial thromboplastin time (aptt) and platelet count cannot detect hyper- or hypofibrinolysis, or hypercoagulability.The safety instructions for the extracorporeal circulation out of the instruction for use of the quadrox id pediatric stating the following: implementing an extracorporeal circulation can cause the associated side effects in the patient, such as infections, hemolysis, embolisms, postperfusion syndrome and organ damage.No anticoagulation or insufficient anticoagulation causes occlusion of the extracorporeal circulation and the patient circuit.This can lead to inadequate patient support, hemolysis or thrombus formation in the patient.Weigh up 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).Ensure that the act value does not fall below the value which is appropriate for the application.Check the coagulation status of the patient's blood regularly.The protocol for coagulation management is the responsibility of the user in charge.This device can be used for ecmo and hlm procedures.The anticoagulation management for this device must correspond to the intended conditions for the respective application.Based on the investigation results the reported failure "clotting" could be confirmed.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.

• Brand Name: QUADROX-ID PÄD
• 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: 12337816
• MDR Text Key: 267109650
• Report Number: 8010762-2021-00456
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: K132829
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Other,Foreign,Consumer,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 03/04/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 07/27/2022
• Device Model Number: BE-HMOD 30000#BE-QUADROX-ID PÄD.O.FILT.
• Device Catalogue Number: 701047041
• Device Lot Number: 70143295
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/25/2022
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 07/27/2020
• Is the Device Single Use?: Yes
• Type of Device Usage: A
• Patient Sequence Number: 1
• Patient Age: 21 MO
• Patient Sex: Female
• Patient Weight: 9 KG