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

Model Number HLS SET

Device Problem Improper Flow or Infusion (2954)

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

Event Date 03/17/2021

Event Type  malfunction  

Manufacturer Narrative

The investigation of the manufacturer is still pending.

Event Description

Complaint id: (b)(4).The customer reported that the product was used with beginning of therapy at 9 am ((b)(6) 2021).In the evening same day continuously drop of blood flow.To maintain adequate flow customer rose the rpm (rotations per minute).On arterial side of oxygenator visible black areas (clots).At 4am ((b)(6) 2021), decision of exchange the oxygenator due to ongoing drop of flow issue.The customer observed similar issues (flow drop and clots on arterial side of oxygenator) with the 2nd (hls set) and 3rd (pls - set) product used for the same patient.These products will be handled by separate mdr reports and complaint numbers ((b)(4)).

Manufacturer Narrative

The following complaint information was provided to maquet cardiopulmonary: "begining of therapy at 9 am (17.03.2021).Evening same day continuously drop of flow.To maintain adequate flow we¿ve rise the rpm.On arterial side of oxygenator visible black areas.At 4am (18.03.2021), decision of exchange the oxygenator due to ongoing drop of flow issue.With this second oxygenator similar flow drop and clots on arterial site was observed.On 7pm decision of another exchange was made and in this case pls set was implemented.After 12 hours finally decision of termination ecmo due to similar problems with pls-set." this complaint record handles the 1st oxygenator mentioned in the above mentioned information.More detailed event information (blood gas analysis, blood parameters, drugs) was not provided by the customer, but requested by maquet cardiopulmonary.Thus an analysis of those parameters by our medical experts was not possible.The provided picture of the customer shows visible black areas (blood clots) at the arterial side of oxygenator.The affected product was investigated at the laboratory of the manufacturer.During cleaning process clots on the upper third half of the arterial side (blood outlet side of product) were confirmed.No visual defects were detected.The centrifugal pump and sensors were fully functional.The production records of the affected hls module (dms# 3046994, 3036040, 3045182) were reviewed on 2021-06-10.Following tests are performed according to the bop (basic operation procedure - maquet cardiopulmonary's procedures for production) as a 100 % inspection: leak test after welding, pressure test heat exchanger, leak test water side, leak and flow test gas side, pressure test blood side, coating test.According to the final test results, the oxygenator with the serial# (b)(6) passed the test as per specifications.Production related influences can be excluded.No product related malfunction which could have caused the reported failure "drop of flow / clotted arterial side" was confirmed during investigation.The most probable cause of the reported failure was based on the investigation findings coagulated blood on the arterial side of the oxygenator module which led to an obstruction of the oxygenator membrane and caused a drop of flow.However with reference to the risk assessment (hls set advanced 5.0 / hls set advanced 7.0, dms # 1468452, v26) and in consultation with the getinge manager medical affairs team the following events can contribute to clotting in the circuit: air remains in or enters the circuit, hemostasis, too low anticoagulation, too low act level, effect of heparin is too limited, protamine sulfate enters the hls set, administration of substitution of congealable substance such as platelets, (consumption) coagulopathy, thrombozytopenia.Further according to the ifu hls set advanced g-360 chapter 5.2.Safety instructions for the extracorporeal circulation no anticoagulation or insufficient anticoagulation and / or 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.Thus the following measures should be followed: 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.Do not administer protamine directly via the oxygenator.Only administer protamine via the patient access.Do not administer protamine until perfusion has ended.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.The occurrence rate was calculated for the reported failure and it was determined that this is not a systemic issue.Therefore, no remedial action is required.The customer observed similar issues (flow drop and clots on arterial side of oxygenator) with the 2nd (hls set) and 3rd (pls - set) product used for the same patient.These products are handled by complaint record # 455062 (hls set) and # 455063 (pls set).

Event Description

Complaint id: (b)(4).

• Brand Name: HLS SET ADVANCED
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• MDR Report Key: 11662793
• MDR Text Key: 245490279
• Report Number: 8010762-2021-00246
• 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: 06/24/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/14/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Expiration Date: 09/20/2021
• Device Model Number: HLS SET
• Device Catalogue Number: 70106.9073
• Device Lot Number: 70144165
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 04/27/2021
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 06/09/2021
• Patient Sequence Number: 1
• Patient Age: 26 YR
• Patient Weight: 82