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

Model Number 102953

Device Problems Mechanical Problem (1384); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Thrombosis/Thrombus (4440)

Event Date 11/21/2022

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 patient was suspected to have heparin induced thrombocytopenia (hit) after their right ventricular assist device (rvad) had clotted on (b)(6) 2022 and it was subsequently removed.Hematology was consulted and ruled out hit.On (b)(6) 2022 at approximately 0400, the patient experienced a decrease in flows from 4.5 to 3 liters per minute (lpm) at a speed of 5400 rotations per minute (rpm).Both the periodic and event log files confirmed the flows at 0 lpm on (b)(6) 2022.A transthoracic echocardiogram (echo) showed a decompressed left ventricle (lv) and potential tamponade.The team was planning to take the patient to the operating room (or) for exploration when the pump flows dropped to zero but because the flows dropped acutely, patient was urgently centrally cannulated for extracorporeal membrane oxygenation (ecmo) support at the bedside and taken to the or.In the or they were found to have clot in the pump, outflow graft and throughout the lv, flows were decreased, and pump was turned off due to the clot.The patient had a therapeutic partial thromboplastin time (ptt) at the time of the event.Patient was on put on acute support with oxygenator and chest was left open, and the pump was to remain off.Additional information was received that the patient passed away on (b)(6) 2022 due to vad thrombosis.The patient was thought to have coagulopathy issues.Patient changed anticoagulation course multiple times post-op due to bleeding issues.The outcome was not considered to be device or therapy related.An autopsy was to be performed, and the device was to return for evaluation.Related mfr: 2916596-2022-15861.

Manufacturer Narrative

Manufacturer's investigation conclusion: the report of the centrimag blood pump clotting could not be confirmed through this evaluation as no product was returned for evaluation.Multiple requests for additional information regarding this event were submitted to the account; no further information was provided.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 venous thromboembolism and arterial non-cns thromboembolism as adverse events that may be associated with the centrimag circulatory support system under ¿adverse events¿.This ifu also provides the following 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 based on risks and benefits to the patient.Ifu warning #10: frequent patient and device monitoring is recommended.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: 16396681
• MDR Text Key: 309878388
• Report Number: 3003306248-2023-00754
• Device Sequence Number: 1
• Product Code: KFM
• UDI-Device Identifier: 07640135140627
• UDI-Public: 07640135140627
• 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: 02/21/2023

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: Lay User/Patient
• Device Model Number: 102953
• Device Catalogue 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: 02/14/2023
• Initial Date FDA Received: 02/17/2023
• Supplement Dates Manufacturer Received: 02/17/2023
• Supplement Dates FDA Received: 02/21/2023
• 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): Other; Required Intervention
• Patient Age: 25 YR
• Patient Sex: Female
• Patient Weight: 122 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: Black Or African American