MAUDE Adverse Event Report: TUBING SET; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number HLS SET

Device Problem Improper Flow or Infusion (2954)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Type  malfunction  

Manufacturer Narrative

The investigation of the manufacturer is still pending.

Event Description

The following information was provided to maquet cardiopulmonary gmbh: oxygenator closed acutely after three days.No other information was provided at this time.

Manufacturer Narrative

The affected product was not available for manufacturer's laboratory investigation as it was discarded by the customer.Thus a laboratory investigation was not possible.As neither the serial #, nor a lot # of the affected product is available, the device history record of the product nor possible related production non-conformances could be reviewed.A review of similar hls set complaints was performed on 2020-12-21 with the following outcome: a similar complaint with an already conducted laboratory investigation was found (#310782).The investigation results were as follows: maquet cardiopulmonary gmbh requested the product for laboratory investigation.The investigation was performed on 2020-06-05.As stated in the investigation report clots were found inside the oxygenator.Furthermore a dhr review was performed with no abnormality or issue found that is related or can have led to the customer complaint.Thus the most probable cause of the oxygenator blockage in complaint (b)(4) are clots within the oxygenator leading to a blockage.Based on this the reported failure could be confirmed but was most probable not caused by a product related malfunction but by clotting as mentioned above.According to the ifu hls set advanced 5.0 / 7.0, hit set advanced 5.0 / 7.0 2.3 g-360 02 the following factors can contribute to clotting / coagulation: 5.2 safety instructions for the extracorporeal circulation 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 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 the partial thromboplastin time (ptt) should be in the range from 60 to 90 seconds.An antithrombin iii (at iii) value in the normal range is required for reliable anticoagulant therapy with heparin.When the event occurred, the device was being used for treatment of the patient.The product was directly involved in the event.The occurrence rate regarding the above complaint is below the acceptance rate.Thus, no remedial action 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: TUBING SET
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• MDR Report Key: 10917388
• MDR Text Key: 218689539
• Report Number: 8010762-2020-00406
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• PMA/PMN Number: K102726
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: consumer,foreign,health profe
• Type of Report: Initial,Followup
• Report Date: 12/22/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/30/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: HLS SET
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 12/16/2020
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1