MAUDE Adverse Event Report: THORATEC SWITZERLAND GMBH CENTRIMAG BLOOD PUMP; CARDIOPULMONARY BYPASS

Model Number 102953

Device Problem Mechanical Problem (1384)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 09/29/2023

Event Type  Injury  

Manufacturer Narrative

No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is completed.

Event Description

It was reported that the centrimag began to have low flow alarms with a flow of 0 lpm with no precipitating event and no accompanying chattering visualized in the drainage tubing.Despite adjustment of the speed, and exchanging of the flow probe, flow above 0 liters per minute (lpm) was unable to be achieved.It was decided by the care team to exchange the blood pump due to the concern that a clot was causing the impedance in flow.After exchanging to a new centrimag blood pump, flow above 0 lpm was still unable to be achieved.Assessment of the tubing most proximal to the patient was done and separation of blood and plasma was visualized.The patient was started on an inotrope (dobutamine), centrimag support was stopped, and the patient was de-cannulated due to presumed clotting of the single-site double lumen cannula inserted in the right internal jugular vein.Prior to the event, patient was systemically anticoagulated and within a therapeutic range.Duration of event was approximately 20 minutes.Due to hemodynamic stability, the patient was not re-cannulated, and support was not resumed at that time.Additionally, the care team further assessed and flushed the original centrimag blood pump and noted there to be no clots formed inside the blood pump.25000u of heparin was given intravenous push throughout the process.Patient remained in the intensive care unit, stable and awaiting heart transplant.Related regulatory reference report mfr # 3003306248-2023-07170; 3003306248-2023-07169; 2916596-2023-07325.

Event Description

It was additionally reported that the thrombus was identified in the protek duo cannula that was used.

Manufacturer Narrative

Section a4: patient weight was requested but was not provided.Section d4: lot number was requested but was not provided.Manufacturer's investigation conclusion: thrombus in the protek duo cannula (not manufactured by abbott) causing no flow through the centrimag system was unable to be confirmed through this evaluation as no photos of the thrombus were provided, no log files were submitted, and no product was returned.A direct correlation between the centrimag blood pump and the report of thrombus in the cannula could not be conclusively established through this evaluation; however, the customer reported that there were no clots within the blood pump.The centrimag blood pump was not returned for evaluation.The lot number or other identifying information of the product was not reported and was not able to be determined during the investigation.The us (united states) centrimag blood pump instructions for use (ifu) (rev.B) lists venous thromboembolism and arterial non-cns (non-central nervous system) thromboembolism as adverse events that may be associated with the use of the centrimag blood pump.The ifu contains the following additional warnings and cautions: 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.Ifu warning #10: frequent patient and device monitoring is recommended.Ifu 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.Ifu 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.Ifu caution #2: this device should only be used by persons thoroughly trained in extracorporeal circulation procedures.Ifu caution #6: attach tubing to the pump in such a manner as to prevent kinks or restrictions that may alter flow or cause regions of stasis or turbulence.Attach in a manner that does not bend or fracture the tubing connectors or ports.Advance the tubing beyond the second barb point of the pump connectors.Ifu caution #9: monitor carefully for any signs of occlusion throughout the circuit.Ifu caution #15: always have a backup centrimag pump, console, motor, and accessories available for use.The section titled pump setup and operation warns the user that if leaks or other anomalies are found in the circuit, remove the pump and replace with a new, sterile pump.The ifu also contains a section titled emergency pump replacement.The 2nd generation centrimag system operating manual (rev.M) section 4 entitled "warnings & precautions" warns "one additional 2nd generation centrimag primary console, motor and flow probe are required as backup system in the immediate vicinity of each patient whenever the centrimag or pedivas blood pump is used.The backup console must be connected to the backup motor and to the backup flow probe, have a battery charge sufficient for at least one hour of operation, be connected to ac power (except during transport) and be immediately available should the main console, motor or flow probe experience a malfunction." section 12.1 entitled "appendix i ¿ console alarms and alerts" in this ifu contains a list of console alarms and alerts, including the f2 and f3 alarms, as well as appropriate operator response to these events.No further information was provided.The manufacturer is closing the file on this event.

• Brand Name: CENTRIMAG BLOOD PUMP
• Type of Device: CARDIOPULMONARY BYPASS
• 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: 17986884
• MDR Text Key: 326295772
• Report Number: 3003306248-2023-07171
• 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: Nurse
• Type of Report: Initial,Followup
• Report Date: 01/23/2024

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?: 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
• Initial Date Manufacturer Received: 10/03/2023
• Initial Date FDA Received: 10/23/2023
• Supplement Dates Manufacturer Received: 01/19/2024
• Supplement Dates FDA Received: 01/23/2024
• 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): Hospitalization; Required Intervention
• Patient Age: 53 YR
• Patient Sex: Female