MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG BLOOD PUMP; PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE

Model Number 102953

Device Problem Mechanical Problem (1384)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 05/07/2020

Event Type  Injury  

Manufacturer Narrative

No additional information has been provided.A supplemental report will be submitted once the manufacturer's investigation is complete.

Event Description

It was reported that the patient presented to the emergency department (ed) with covid-19 symptoms 25 days prior to their scheduled heartmate 3 (hm 3) implant date.The patient had tested negative for covid-19 multiple times, but required extracorporeal membrane oxygenation (ecmo) support, and was diagnosed with lymphocytic viral myocarditis.They were centrally cannulated and put on biventricular centrimag (cmag) support with an oxygenator inline with a right ventricular assist device (rvad).Due to continued right ventricle (rv) dysfunction, the patient required temporary rvad support with a durable left ventricular assist device (lvad).It was decided that the implant procedure would be performed in two stages.The first stage was performed in a hybrid room for placement of a protek duo cannula and initiation of a new temporary rvad.The second stage was for the transfer of the patient to the operating room (or) for the durable lvad placement.During the first stage, while in the hybrid room, the patient¿s rvad was 3800rpm with 4.0lpm and lvad at 4200rpm with 4.2lpm.The protek duo cannula was inserted under fluoroscopy without issue.The new rvad was connected to the protek duo cannula and was initiated to provide 2.0 lpm with the original rvad flow of 2.0 lpm.The patient was then transferred to the or for stage 2 where a full sternotomy was performed.The hm 3 was primed and the dissection of the rvad was performed.The patient was transitioned from ecmo to cardiopulmonary bypass (cpb) support and the cannulas were removed from the existing grafts, after the original rvad and lvad were turned off.A transthoracic echocardiogram (tte), that was taken prior to the two procedures, had shown a potential left ventricle (lv) thrombus.The thrombus was removed and the existing graft at the ascending aorta was used to perform a graft to graft anastomosis distal from the hm3 bend relief.

Manufacturer Narrative

Section d4: multiple requests were made to obtain the serial number of this device, however this information was not provided.Manufacturer's investigation conclusion: a specific cause for the reported events as well as a direct correlation to the centrimag blood pump could be conclusively determined through this evaluation.It was reported that the patient presented to the emergency department (ed) with covid-19 symptoms including poor oxygenation.The patient was initially centrally cannulated and supported by biventricular centrimag support with an oxygenator in line with a right ventricular assist device (rvad).Due to continued right ventricle (rv) dysfunction the patient required rvad temporary support with durable lvad.The patient was transferred to a hybrid room for placement of protek duo cannula in the internal jugular and initiation of a new temporary rvad using fluoroscopy.The new rvad was set at 3800 revolutions per minute (rpm) with 4.0 liters per minute (lpm) flow and the lvad was set at 4200 rpm with 4.2 lpm flow.The patient was then transferred to the operating room where a full sternotomy and heartmate 3 lvad implant was performed.Prior to heartmate 3 implant, a transthoracic echocardiogram (tte) showed a potential left ventricle (lv) thrombus.The thrombus was visualized within the temporary centrimag lv cannula.The thrombus was removed, and the patient was implanted with heartmate 3 lvad and temporary lvad and rvads were removed.The lot number of the centrimag was not available.The centrimag will not be returned for evaluation.The centrimag blood pump instructions for use (ifu) lists arterial non-cns thromboembolism as an adverse event associated with the use of the centrimag blood pump.This ifu instructs that systemic anticoagulation be utilized while the device is in use.Anticoagulation levels should be determined by the physician based on risks and benefits to the patient.Frequent patient and device monitoring is recommended.The lot number of the centrimag blood pump was not available.The centrimag blood pump instructions for use (ifu) is currently available.The centrimag blood pump ifu lists arterial non-cns thromboembolism as an adverse event associated with the use of the centrimag blood pump.Warning #7: it is intended that systemic anticoagulation be utilized while this device is in use.Anticoagulation levels should be determined by the physician based on risks and benefits to the patient.Warning #15: monitor the patient¿s hemodynamics and the console flow display to ensure adequate blood volume for the inlet cannula position, pump rpm, and desired flow.Increase the pump rpm in small increments to minimize the risk of exceeding the available blood volume and causing inlet cannula obstruction, suction, outgassing, and/or cavitation.Warning #16: as with all continuous flow pumps, operating at too high a speed can result in negative pressure at the inlet which can lead to collapse of the ventricle or blood vessels, inlet cannula obstruction, inspiration of air, outgassing, cavitation and increased risk of embolism.Always operate the system at the lowest speed consistent with the volume of blood available to be pumped and clinically acceptable circulatory support.Cautions #15: always have a backup centrimag pump, console, motor, and accessories available for use.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: CENTRIMAG BLOOD PUMP
• Type of Device: PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CH-80 05; SZ CH-8005
• Manufacturer (Section G): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CH-80 05; SZ CH-8005
• Manufacturer Contact: bob fryc ; 6035 stoneridge drive; pleasanton, CA 94588 ; 7818528204
• MDR Report Key: 14028714
• MDR Text Key: 291948381
• Report Number: 3003306248-2022-00054
• Device Sequence Number: 1
• Product Code: KFM
• UDI-Device Identifier: 07640135140627
• UDI-Public: 7640135140627
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K020271
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 05/11/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/06/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Model Number: 102953
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Date Manufacturer Received: 05/10/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Hospitalization
• Patient Age: 23 YR
• Patient Sex: Male
• Patient Weight: 86 KG