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

Model Number BEQ-HMOD70000-USA #SQUADROX-ID AD.O.FIL.

Device Problem Decrease in Pressure (1490)

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

Event Date 05/17/2023

Event Type  malfunction  

Manufacturer Narrative

The investigation is ongoing.Further information has been requested but has not yet been received.A follow up medwatch will be submitted when additional information becomes available.

Event Description

The event occurred in the us.It was reported that the flow of the quadrox-id dropped from 3.2 lpm (liters per minute) to 0.5 lpm during patient treatment.The patient was not on any anticoagulation.This complaint is related with the hardware complaint ot (b)(4).The oxygenator was exchanged during patient treatment.No harm to any person has been reported.Complaint id: (b)(4).

Manufacturer Narrative

The event occurred in the us.It was reported that the flow of the quadrox-id dropped from 3.2 lpm (liters per minute) to 0.5 lpm during patient treatment.The patient was not on any anticoagulation.The oxygenator was exchanged during patient treatment.No harm to any person has been reported.This complaint is related to complaint (b)(4) which was reported under mfd#8010762-2023-00226.The affected beq-hmod70000-usa #squadrox-id ad.O.Fil.Was investigated in the getinge laboratory with the following results: during the investigation clotting on the venous and arterial side are visual however, the reported failure could not be reproduced.No malfunction or abnormal pressures on the product could be detected.Based on the investigation results the reported failure could not be confirmed.However, a probable root cause could be clotting which could lead to flow decreasing on the blood side.The device history review (dhr) records were reviewed on 2023-10-16 and according to the final test results, all the beq-hmod70000-usa #squadrox-id ad.O.Fil.With lot#3000194868 passed the tests as per specifications.Production related influences are unlikely.This complaint was found in the database of customer complaints for the 701067859 beq-hmod70000-usa #squadrox-id ad.O.Fil.As a single event (timeframe from 2023-05-18 -2022-05-18).In order to avoid re-occurrence of the reported failure, the sales and service unit (ssu) will inform the customer to follow the chapter in the instruction for use instructions for use oxygenator quadrox-id adult g-605 version 04 · us: 4.2 safety instructions for the extracorporeal circulation.Absence of adequate anticoagulation results in clotting within the system and consequently occlusion of the extracorporeal circuit and the patient circuit.This can lead to inadequate patient support, thrombus formation, hemolysis, hemostasis, and ischemia.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.The customer will be informed about the results by the getinge sales and service unit.The occurrence rate was calculated for the reported failure and product 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): JULIA KAPFENBERGER; neue rottenburger strasse 37; hechingen
• Manufacturer Contact: neue rottenburger strasse 37; hechingen
• MDR Report Key: 16972693
• MDR Text Key: 315654218
• Report Number: 8010762-2023-00227
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K101153
• 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,Followup
• Report Date: 10/25/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/22/2023
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/23/2023
• Device Model Number: BEQ-HMOD70000-USA #SQUADROX-ID AD.O.FIL.
• Device Catalogue Number: 701067859
• Device Lot Number: 3000194868
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/29/2023
• Was Device Evaluated by Manufacturer?: Yes
• Date Device Manufactured: 09/23/2021
• Is the Device Single Use?: Yes
• Type of Device Usage: Initial
• Patient Sequence Number: 1