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); Overheating of Device (1437)

Patient Problems Dyspnea (1816); Thrombosis/Thrombus (4440)

Event Date 03/20/2023

Event Type  Injury  

Manufacturer Narrative

Related mfr # 2916596-2023-01691 covers the patient's left motor.Related mfr # 3003306248-2023-01396 covers the patient's left console.Related mfr # 2916596-2023-01947 covers the patient's right motor.Related mfr # 2916596-2023-01948 covers the patient's right console.Related mfr # 2916596-2023-01951 cover's the patient's second centrimag blood pump.Lot number for blood pump requested, information not yet provided.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 on centrimag biventricular support and lost forward flow.Symptoms included shortness of breath.Additional information was provided that an echocardiogram was performed, and the patient had a clot formation throughout the whole heart.Further explanation was given that the heart was not beating, not ejecting, and clot formed from stagnation.The original motor and console were exchanged, and forward flow was briefly reinstated before becoming lost again the following day, when another clot had broken off and entered the right support system and stopped forward flow.The second motor and console were exchanged.The exchanging of both the left and right-side motors and consoles reinstated forward flow.It was also noted that the centrifugal head of the motor was very hot to touch.

Manufacturer Narrative

Manufacture¿s investigation conclusion: the report of clot entering the centrimag blood pump could not be confirmed through this evaluation as no product was returned for evaluation.Review of the log files retrieved from both consoles revealed that the system alarmed for low pump speed and low flow events associated with both centrimag blood pumps on 17mar2023 and 18mar2023, respectively.These events appeared consistent with the report that clots had broken off from the patient's heart, entered the pump, and interfered with pump flow on two separate days.Additionally, although it was noted that the centrifugal head was hot to the touch, temperature values recorded in the log files were not high enough to result in any alarms.The united states centrimag blood pump instructions for use (ifu) lists thromboembolic events as adverse events that may be associated with the centrimag circulatory support system.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 instructions for use (ifu) lists thromboembolic events 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.The serial number or other identifying information of the product was not reported and was not able to be determined during the investigation.No further information was provided.The manufacturer is closing the file on this event.

Event Description

It was reported that the patient was no longer on centrimag support.The blood pumps were ruled out as the problem at the time of the incident and remained on the patient until support was discontinued; at that point in time the pumps were discarded.

Manufacturer Narrative

Correction: the initial report was incorrectly submitted with a cfn-based manufacturer report (mfr) number: 2916596-2023-01950.The mfr number should have been fei-based with the 10 digit fei being 3003306248.

• Brand Name: CENTRIMAG BLOOD PUMP
• Type of Device: PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
• Manufacturer (Section D): THORATEC SWITZERLAND GMBH; technoparkstrasse 1; zurich CA 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: 16664744
• MDR Text Key: 312531341
• Report Number: 2916596-2023-01950
• 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: Biomedical Engineer
• Type of Report: Initial,Followup,Followup
• Report Date: 07/24/2023

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: 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: 03/20/2023
• Initial Date FDA Received: 04/03/2023
• Supplement Dates Manufacturer Received: 06/14/2023; 07/24/2023
• Supplement Dates FDA Received: 06/20/2023; 07/24/2023
• 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): Hospitalization; Required Intervention
• Patient Age: 64 YR
• Patient Sex: Male
• Patient Weight: 97 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White