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

Model Number 102953

Device Problems Mechanical Problem (1384); Infusion or Flow Problem (2964); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Bacterial Infection (1735); Pain (1994); Respiratory Tract Infection (2420); Respiratory Failure (2484); Thrombosis/Thrombus (4440); Heart Failure/Congestive Heart Failure (4446); Swelling/ Edema (4577); Peripheral Edema (4578)

Event Date 05/18/2023

Event Type  Injury  

Event Description

It was reported that the patient had placed left ventriucular assist device surgery (lvad) on (b)(6) 2023.When the patient was gradually weaned off the cardiopulmonary bypass.They had severe right ventricular failure.This required a temporary right ventricular assist device (rvad) (centrimmag without oxygenator) the chest was packed and left open.The subject was transferred to intensive care unit (icu) in stable but critical condition.On (b)(6) 2023, the patient was brought back to the operating room for chest closure.It was determined that the subject continued to need rvad support.At this time, a protek duo cannula was placed using fluoroscopy and transesophageal echocardiogram, (tee) guidance.The protek duo cannula was then connected to the rvad circuit with good flows.The patient's chest was closed.The patient remained on this temporary rvad until they developed a clot in the circuit that necessitated bedside decannulation on (b)(6) 2023.The last dose of inotropes was on (b)(6) 2023.The patient had a rising white blood cell (wbc) count starting on (b)(6) 2023.Sputum cultures were positive for enterococcus faecalis on (b)(6) 2023.The patient was treated with vancomycin on (b)(6) 2023 and (b)(6) 2023 and meropenem on (b)(6) 2023 to (b)(6) 2023.No further respiratory cultures were taken.The patient had decreased right ventricular assist device (rvad) flow with concerns for thrombus on (b)(6) 2023.The patient had no flow alarms.There was increased clot/fibrin throughout the circuit and connectors within the circuit.The cannula had fibrin at the tubing connectors as well as at the y junction of the pro-tek.On (b)(6) 2023the patient had right internal jugular thrombus as well as right upper extremity edema with associated pain.A doppler ultrasound of the patient's upper extremity revealed a nonocclusive right jugular thrombus.The patient was already on warfarin therapy.The wbc peaked at 38.510e3/ul on (b)(6) 2023.

Manufacturer Narrative

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

Manufacturer Narrative

The left ventricular assist device (lvad) involved in this event is reported under mfr #: 2916596-2023-05614.Manufacturer's investigation conclusion: the reported thombus within the centrimag blood pump could not be confirmed through this evaluation as no product was returned for evaluation.Additionally, a direct correlation between the device and the reported patient conditions could not be conclusively established through this evaluation.The patient is no longer on centrimag support.The blood pump was not returned for evaluation.Review of the device history record (dhr) for the centrimag blood pump revealed no deviations from manufacturing or quality assurance specifications.The centrimag blood pump instructions for use (ifu) (rev.09) is currently available.This ifu lists thromboembolic events, respiratory failure, and infection as adverse events that may be associated with the use of the centrimag blood pump.The ifu provides the following warnings and cautions: 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.Warning 10: frequent patient and device monitoring is recommended.Warning 12: do not operate the pump in the absence of forward flow.The temperature within the pump will rise and increased cellular damage and clotting may result.Warning 15: monitor the patient¿s hemodynamics and the console flow display to ensure adequate blood volume for the inlet cannula position, pump revolutions per minute (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.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.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.Caution 15: always have a backup centrimag pump, console, motor, and accessories available for use.The 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 low flow alarms, as well as appropriate operator response to these events.No further information was provided.The manufacturer is closing the file on this event.

Event Description

Additional information: it was reported that no further respiratory cultures were taken, and the patient¿s wbc began down-trending on (b)(6) 2023.As of (b)(6) 2023 the patient had been on inotropes greater than 14 days post index procedure.Their last dose was on (b)(6) 2023.The patient was ultimately discharged on (b)(6) 2023.

• Brand Name: CMAG 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: 17188375
• MDR Text Key: 317731745
• Report Number: 3003306248-2023-01949
• 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: Study,Health Professional,Company Representative
• Reporter Occupation: Physician
• Type of Report: Initial,Followup
• Report Date: 10/19/2023

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 Expiration Date: 03/25/2024
• Device Model Number: 102953
• Device Lot Number: L06984-LA8
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 06/07/2023
• Initial Date FDA Received: 06/23/2023
• Supplement Dates Manufacturer Received: 10/18/2023
• Supplement Dates FDA Received: 10/19/2023
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 11/05/2021
• 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: 54 YR
• Patient Sex: Female
• Patient Weight: 112 KG