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 Problems Cardiac Arrest (1762); Pneumothorax (2012); Renal Failure (2041); Fungal Infection (2419); Thrombosis/Thrombus (4440); Respiratory Insufficiency (4462)

Event Date 04/21/2022

Event Type  Injury  

Event Description

It was reported that the patient experienced bleeding during the pump implant procedure on (b)(6) 2022.On (b)(6) 2022 the patient coded during intubation for metabolic respiratory distress due to multi-system organ failure and acute kidney injury (aki) from the implant procedure bleeding.A red heart alarm and low flow alarm were noted.Upon initial bagging, the patient lost all flow in their left ventricular assist device (lvad) and right ventricular assist device (rvad.The patient received chest compressions and a tracheotomy.Imaging caused concern for a tension pneumothorax and bilateral chest tubes were placed.Multiple bronchoscopies showed pulmonary edema.Multiple echocardiograms (echos) confirmed the positioning of the pump in the left ventricle and the size of the patient's left ventricle was causing a flow backup into the left atrium and subsequently causing the pulmonary edema.The patient continued on lvad and rvad support as well as continuous venovenous hemofiltration (cvvh).They were sedated with 80% fraction of inspired oxygen (fio2) and on inotropic support.The patient continued to have lvad suction events and drops in flow in their rvad as they were waking up and coughing despite multiple speed changes in attempts to stop the suction events.A bronchoscopy was planned for 18may2022.The patient was not following commands or making purposeful movements.A computed tomography (ct) scan was performed on (b)(6) 2022 that revealed mild intracranial atherosclerotic plaque and no signs of acute hemorrhage or ischemia.The patient was recovering from their neurological dysfunction and remained on continuous venovenous hemofiltration (cvvh) for their renal dysfunction.They were positive for candida albicans from a respiratory culture source, and blood cultures were positive on (b)(6) 2022.

Manufacturer Narrative

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

Event Description

Additional information was received that there was a confirmed clot in the femoral venous line that appeared stable.When the console and motor stopped, thrombus was noted and it was unknown if it was during the stop or prior.It was thought that the known thrombus gave way while the lines were being manipulated for transport and went to the pump head and occluded it.The pump then overheated and turned itself to 0 rotations per minute (rpm).This was turned back on quickly and the same thing happened.The console, motor, monitor, and circuit were exchanged.Related manufacturer's report number for exchanged console: 3003306248-2022-10695.Related manufacturer's report number for exchanged motor: 3003306248-2022-10696.Related manufacturer's report number for exchanged monitor: 3003306248-2022-10697.

Manufacturer Narrative

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

Manufacturer Narrative

Section h6: health effect - clinical code: 3261 - multiple organ dysfunction syndrome.Manufacturer's investigation conclusion: the report of suspected thrombus could not be confirmed through this evaluation, as no images were submitted and the device was not returned for evaluation.A direct correlation between the reported events and the centrimag blood pump could not be conclusively established through this evaluation.Additionally, a specific cause for the reported infection could not be conclusively determined.It was reported that on (b)(6) 2022 the patient coded during intubation for metabolic respiratory distress due to multi-system organ failure and acute kidney injury (aki) from the implant procedure bleeding.Upon initial bagging, the patient lost all flow in their left ventricular assist device (lvad) and right ventricular assist device (rvad).The patient received chest compressions and a tracheotomy.Imaging caused concern for a tension pneumothorax, and bilateral chest tubes were placed.Multiple bronchoscopies showed pulmonary edema.The patient continued on lvad and rvad support as well as continuous venovenous hemofiltration (cvvh).They were sedated and on inotropic support.The patient continued to have lvad suction events and drops in flow in their rvad as they were waking up and coughing despite multiple speed changes in attempts to stop the suction events.A bronchoscopy was planned for (b)(6) 2022.Following the patient¿s arrest/code, the patient suffered altered mental status and could not follow commands or purposeful movements.A computed tomography (ct) scan was performed on (b)(6) 2022 that revealed mild intracranial atherosclerotic plaque and no signs of acute hemorrhage or ischemia.The patient was recovering from their neurological dysfunction and remained on cvvh for their renal dysfunction.A respiratory culture came back positive, and blood cultures were positive on (b)(6) 2022.Additional information was received stating there was a confirmed clot in the femoral venous line that appeared stable.Upon preparing the patient for transport to the operating room (or) on (b)(6) 2022, the perfusionist noticed the flow and speed on the rvad decreased to zero.He went to increase speed and it stopped again.The centrimag motor and console were switched out, but the speed was still unable to hold (related manufacturer report numbers 3003306248-2022-10695 and 3003306248-2022-10696).The circuit was replaced, and the pump flow and patient stability returned.It was believed that the known clot burden in the femoral line gave way while the lines were being manipulated for transport and occluded the pump head, thereby stopping the flow.The centrimag blood pump was discarded and not available 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 ifu (rev.09) lists multiple types of organ failure and dysfunction (respiratory failure and renal failure), neurological dysfunction, and thromboembolism as adverse events that may be associated with the use of the centrimag circulatory support system.The ifu contains the following additional warnings and precautions: 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 warming #10: frequent patient and device monitoring is recommended.Ifu 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.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 spare centrimag blood pump, back-up console, and equipment available for change out.No further information was provided.The manufacturer is closing the file on this event.

Event Description

Related manufacturer's report number for lvad: 2916596-2022-10944.

• 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: 14618965
• MDR Text Key: 293448659
• Report Number: 3003306248-2022-10708
• 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,Followup
• Report Date: 08/18/2022

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/07/2022
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• 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
• Date Manufacturer Received: 08/17/2022
• 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): Hospitalization; Required Intervention
• Patient Age: 61 YR
• Patient Sex: Male
• Patient Weight: 104 KG
• Patient Ethnicity: Hispanic