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 04/01/2022

Event Type  Injury  

Event Description

It was reported through the research article "temporary right ventricular assist device support with a 29-french protek duo cannula to centrimag pump in a 12-year-old after left ventricular assist device placement" that right ventricular failure (rvf) after left ventricular assist device (lvad) placement occurs in approximately 20% of patients.The protek duo system by tandemlife can provide access for temporary right ventricular assist device (rvad) support in adults.The first published case of protek duo to temporary centrimag rvad support in a pediatric patient with rvf after lvad placement is outlined.The patient presented with severe left ventricular (lv) dilation and dysfunction and moderate rv dysfunction.The patient had intermacs profile 2 symptoms, and underwent heartmate 3 (hm3) lvad placement on hospital day (hd) 8.Genetic testing identified a pathogenic tnnt2 mutation.The patient initially did well but on hd 13, lvad flow and perfusion worsened.A cardiac catheterization was performed on hd 15, a transesophageal echocardiogram identified a posterior pericardial thrombus and large effusion requiring needle decompression.Severe rv dysfunction persisted, so a 29fr protek duo cannula was placed in the right internal jugular vein, which measured 10£ 11mm, connected to centrimag pump for right ventricular assist device (rvad) support.Placement was complicated by thrombus formation on the outflow tip, which was displaced via fogarty balloon application technique.At the time activated clotting time (act) was 186 although an act of 300-400 is recommended.Once the thrombus resolved, centrimag flow was 4 l/min and hm3 flow was 4.5-5 l/min.On hd 17 the patient underwent a chest washout and was extubated on hd 18.While supported on rvad, he continued rehabilitation with the cannula secured to his scalp with coban, progressing to 250 ft ambulation in one session.On hd 25, he had mild rv dysfunction and preserved end-organ function, so rvad flow was weaned daily over 11 days to 1800 rpm.Rvad support was removed without event on hd 36, and he was discharged on hd 63.He is over 180 days post-hm3 implantation with moderately decreased biventricular function.Ambulation was continued once stable on the rvad, which was weaned off after 21 days of support.Related manufacturer report number: 2916596-2022-11335.

Manufacturer Narrative

Specific patient information and device serial number are documented as unknown.Date of event has been entered as the same as published date (april 2022) since date of data collection was not provided.The event took place at (b)(6).Article information: b.A.Madden, et al.Temporary right ventricular assist device support with a 29-french protek duo cannula to centrimag pump in a 12-year-old after left ventricular assist device placement, the journal of heart and lung transplantation, vol 41, no 4s, april 2022.Manufacturer's investigation conclusion: a report of a thrombus on the centrimag outflow tip could not be confirmed through this evaluation as the device was not returned for evaluation and no photos were submitted for review.A specific cause for the reported event could not be determined through this evaluation.The centrimag device serial number and other specific case/patient information are not available and were not requested.No product was evaluated under this complaint.The united states (us) centrimag blood pump instructions for use (ifu) lists adverse events that may be associated with the centrimag circulatory support system including thromboembolism.The ifu warns the user to monitor the circuit carefully for any signs of occlusion.Additionally, this ifu states that the pump is intended to be used with systemic anticoagulation and anticoagulation levels should be determined by the physician based on risks and benefits to the patient.This document also instructs the user to always have a spare centrimag blood pump, back-up console, and equipment available for change out.The centrimag blood pump ifu lists thromboembolism as an adverse event that may be associated with the use of the centrimag circulatory support system.The ifu contains the following additional warnings and precautions: ifu 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.Ifu warming #10: frequent patient and device monitoring is recommended.Ifu warning #19: do not restart the pump if the pump has been stopped for more than 5 minutes without adequate anticoagulation, as the risk of thromboembolism is increased after blood has remained stagnant in the pump, extracorporeal circuit, connectors, and cannulae.Ifu caution #2: this device should only be used by persons thoroughly trained in extracorporeal circulation procedures.Ifu caution #9: monitor carefully for any signs of occlusion throughout the circuit.Ifu caution #15: always have a spare centrimag blood pump, back-up console, and equipment available for change out.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: 14548862
• MDR Text Key: 292986291
• Report Number: 3003306248-2022-10706
• 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: Literature
• Reporter Occupation: Non-Healthcare Professional
• Type of Report: Initial
• Report Date: 05/31/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: 102953
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/25/2022
• Initial Date FDA Received: 05/31/2022
• 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
• Patient Age: 12 YR
• Patient Sex: Male