MAUDE Adverse Event Report: MAQUET CARDIOPULMONARY GMBH HLS SET ADVANCED 7.0; OXYGENATOR, CARDIOPULMONARY BYPASS

Model Number BE-HLS 7050#HLS SET ADVANCED 7.0

Device Problems Improper Flow or Infusion (2954); Pressure Problem (3012)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 07/29/2020

Event Type  malfunction  

Event Description

Device concerned: cec circuit for cardiohelp ref bf hls 7050 / lot 70138124 and cardiohelp console (serial number (b)(4)).Date of incident: (b)(6) 2020.Problem observed: a few hours after setting up ecmo, there was initially an increase in delta p on the cardiohelp display, which put the console in alarm.No repercussion on the patient, the 2 cannulas are of different color, there is not a suspicion of a clot on the membrane (patient with acute hepatocellular insufficiency with factor v at 8%), the blood gases on the patient and the 'ecmo are correct.The ecmo anticoagulation is okay.After one hour, persistence of the increase in delta p which increases to 343 mm hg.Test of vascular filling and reduction of doses of norepinephrine: no effect.This causes a drop in flow on the console and results in hypoperfusion of the patient ( pa, sa o2), and a degradation of the patient's vital functions.Action taken: change of the ecmo console + oxygenator + cec circuit.No more problems noted, improved patient condition." complaint id: (b)(4).

Manufacturer Narrative

The product was investigated in the laboratory of maquet cardiopulmonary with the following results: during visual inspection of the product it was determined that the blood outlet side of the oxygenator was clotted.Thus the product has to be cleaned several times with sodium hypochlorite.Additionally a tightness test was performed, no leakages were detected.Afterwards the hls module was connected to the cardiohelp device.All pressure sensors of the hls module were shown up at the cardiohelp's monitor.Furthermore the hls module was tested for the delta p measurement.The pressure parameters were calibrated and the delta p was set to 100mmhg.After 30 minutes no change of the value was observed, after 1 one the value was still constant.No inoperability of the pressure measurement sensors of the hls module was detected.Based on the results of the laboratory investigation no root cause could be determined.As a completely clotted blood outlet side was detected during visual inspection of the product the most probable cause of the reported event could be clotting leading to a blockage of the oxygenator and the rising delta pressure.Due to the impaired blood flow the oxygenation performance of the oxygenator was decreased.According to the ifu hls set advanced 5.0 / 7.0 1.5 / g-270 / 02 following causes could led to coagulation: 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.A device history record review was performed.There were no references found, which are indicating a nonconformance of the product in question.Thus the reported failure could be confirmed but was not be attributed to a device related malfunction.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.

Event Description

Complaint id:(b)(4).

• Brand Name: HLS SET ADVANCED 7.0
• Type of Device: OXYGENATOR, CARDIOPULMONARY BYPASS
• Manufacturer (Section D): MAQUET CARDIOPULMONARY GMBH; neue rottenburger strasse 37; hechingen
• MDR Report Key: 10377954
• MDR Text Key: 202005888
• Report Number: 8010762-2020-00247
• Device Sequence Number: 1
• Product Code: DTZ
• Combination Product (y/n): N
• PMA/PMN Number: K112360
• 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: 10/08/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: BE-HLS 7050#HLS SET ADVANCED 7.0
• Device Catalogue Number: 701047753
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 08/13/2020
• Initial Date Manufacturer Received: 08/03/2020
• Initial Date FDA Received: 08/07/2020
• Supplement Dates Manufacturer Received: 10/06/2020
• Supplement Dates FDA Received: 10/08/2020
• Is This a Reprocessed and Reused Single-Use Device?: Yes
• Patient Sequence Number: 1