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 Problems Hemorrhagic Stroke (4417); Thrombosis/Thrombus (4440)

Event Date 03/20/2022

Event Type  Injury  

Event Description

It was reported that on (b)(6) 2022 the patient suffered a middle cerebral arterial stroke post extubation.Treatment was successful and the patient regained function.On (b)(6) 2022 the patient developed right ventricular failure and a right ventricular assist device (rvad) was placed.The patient was also put on veno-pulmonary artery extracorporeal membrane oxygenation (ecmo).On (b)(6) 2022 the patient suffered a large right intra-parenchymal hemorrhage with a midline shift and herniation of cisterns.A right craniectomy was done and an rvad thrombosis formed since anticoagulation was held for a prolonged period.On (b)(6) 2022 the patient was weaned off of the rvad and ecmo.On (b)(6) 2022 two evaluations were done and both were consistent and confirmed brain death.On (b)(6) 2022 an apnea test was performed but aborted at two minutes due to hemodynamic instability.The patient's time of death was 19:05 on (b)(6) 2022.Related manufacturer report number: 2916596-2022-11344.

Manufacturer Narrative

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

Manufacturer Narrative

Manufacturer's investigation conclusion: a direct correlation between the centrimag device and the reported thrombosis and hemorrhagic stroke could not be conclusively established through this evaluation.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 centrimag blood pump instructions for use (ifu) lists thromboembolism, stroke, bleeding, and death as adverse events that may be associated with the centrimag circulatory support system.This ifu also provides the following warnings and cautions: ifu warning #7: it is intended 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.Ifu warning #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 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: 14569317
• MDR Text Key: 293360072
• Report Number: 3003306248-2022-10704
• 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: 08/02/2022

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
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/18/2022
• Initial Date FDA Received: 06/01/2022
• Supplement Dates Manufacturer Received: 08/01/2022
• Supplement Dates FDA Received: 08/02/2022
• 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): Life Threatening; Required Intervention
• Patient Age: 55 YR
• Patient Sex: Male
• Patient Weight: 110 KG