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 Stroke/CVA (1770); Hemorrhage/Bleeding (1888); Liver Damage/Dysfunction (1954); Respiratory Failure (2484); Thromboembolism (2654); Melena (4480); Renal Impairment (4499)

Event Date 04/13/2021

Event Type  Death  

Manufacturer Narrative

The results/method and conclusion codes along with investigation results will be provided in the final report.

Event Description

It was reported that on (b)(6) 2021 a ct (computerized tomography) scan showed decreased kidney and splenic perfusion suggestive of kidney and splenic infarction.On (b)(6) 2021, the patient's chest ct showed a new thrombi/atheroma in aortic arch with suspected correspondence to renal and splenic infarcts.The patient had continued infarction indications on the ct results from (b)(6) 2021, which was suspect association to newly development aortic thrombus.It was reported that the patient had arterial non-cns thromboembolism.The patient is on anticoagulation therapies at the time of the event.On (b)(6) 2021 the patient received 1 unit of packed red blood cells during a tracheostomy procedure.The patient received multiple unites of red blood cells following the evening of (b)(6) 2021 with the patient experiencing multifactorial contributing sources of bleeding.The patient noted to have experienced large bloody bowel movements along with excess bleeding from internal jugular and arterial lines.On (b)(6) 2021 a carotid ct scan showed new near occlusive adherent thombus extending from the right proximal ica to mid cervical ica.A head ct on that same day showed internal development of left frontal lobe aca territorial infarct (acute/subacute).Per neurology, the patient no longer withdrew from peripheral or central noxious stimuli the following day.The patient passed away on (b)(6) 2021.No additional information was provided.

Event Description

It was reported that the patient also had a right upper quadrant ultrasound performed for management/assessment of suspected transaminitis.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported events, as well as a direct correlation to the centrimag blood pump, could not conclusively be determined through this evaluation.The patient received circulatory support via a centrimag, and the reported events began on (b)(6) 2021.During the reported events, a ct (computed tomography) scan showed decreased kidney and splenic perfusion suggestive of kidney and splenic infarction.A carotid ct scan showed new near occlusive adherent thrombus extending from the right proximal internal carotid artery to mid cervical internal carotid artery, confirming an arterial non-cns thromboembolism with suspected correspondence to the renal and splenic infarcts.The patient was on anticoagulation therapies.The patient underwent a splenectomy in which a large hematoma was removed.The patient experienced bleeding from multiple sources for which the patient received blood transfusions.The patient also experienced large bloody bowel movements along with excess bleeding from internal jugular and arterial lines.The patient had neurologic dysfunction; a head ct showed internal development of left frontal lobe anterior cerebral artery territorial infarct (acute/subacute).Per neurology, the patient no longer withdrew from peripheral or central noxious stimuli the following day.The patient passed away on (b)(6) 2021.The blood pump was discarded at site and was not returned.No further issues have been reported at this time.The device history record for centrimag blood pump lot #l0000008 was reviewed and showed no deviations from manufacturing or quality assurance specifications.The centrimag blood pump instructions for use (ifu) lists bleeding, arterial non-cns thromboembolism, renal dysfunction, neurologic dysfunction, and hepatic dysfunction 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 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 warning #21: use of the pump for periods longer than 30 days may result in pump failure, reduced pumping capacity, excessive blood trauma, and/or degradation of blood contact materials (with possible particles passing through the cannulae to the patient), leaks, and increased potential for gaseous emboli.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.

Event Description

Additional information: it was reported that on (b)(6) 2021 the patient was noted to have bleeding around their right extremity cannulation site as well the left extremity groin incision.Both sites appeared hemostatic following additional sutures being placed and lidocaine and epinephrine injections surrounding the sites.Three units of red blood cells were administered.On (b)(6) 2021 the patient was returned to the operating room for continued mediastinal hemorrhage and exploration of the chest for bleeding.An additional three units of red blood cells were administered during the chest exploration.Following sternal closure on (b)(6) 2021, the patient experienced continued multifactorial decrease in hemoglobin with chest tube and outflow graft tube output which was less than two liters over a 24 hour period.Sternal incision bleeding was also noted.The patient received (b)(4) units of red blood cells between (b)(6) 2021 and (b)(6) 2021 during and following the sternal closure.

Manufacturer Narrative

Manufacturer's investigation findings: the patient received circulatory support via a centrimag, and the reported events began on (b)(6) 2021 when patient was noted to have bleeding around right extremity cannulation site and well as left extremity groin incision.The patient returned to operating room (or) for continued mediastinal hemorrhage and exploration of chest for bleeding.They received 12 unites packed red blood cells (prbc¿s) as well as lidocaine/epinephrine injections, and the bleeding resolved without sequelae.The patient tested negative for covid-19.During the reported events, a ct (computerized tomography) scan showed decreased kidney and splenic perfusion suggestive of kidney and splenic infarction.A carotid ct scan showed new near occlusive adherent thrombus extending from the right proximal ica to mid cervical ica., confirming an arterial non-cns thromboembolism with suspected correspondence to the renal and splenic infarcts.The patient was on anticoagulation therapies.The reported events, as well as a direct correlation to the centrimag blood pump, could not conclusively be determined through this evaluation.The blood pump was discarded at site and was not returned.No further issues have been reported at this time.The device history record for centrimag blood pump lot #l0000008 was reviewed and showed no deviations from manufacturing or quality assurance specifications.The centrimag blood pump instructions for use (ifu) lists bleeding, arterial non-cns thromboembolism, renal dysfunction, neurologic dysfunction, and hepatic dysfunction as adverse events that may be associated with the centrimag circulatory support system under ¿adverse events¿.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 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 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 warning #21: use of the pump for periods longer than 30 days may result in pump failure, reduced pumping capacity, excessive blood trauma, and/or degradation of blood contact materials (with possible particles passing through the cannulae to the patient), leaks, and increased potential for gaseous emboli.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.

Event Description

Additional information: it was reported that the patient was started on continuous renal replacement therapy (crrt) due to decreasing urinary output (uop) and hyperkalemia alongside increasing creatinine.It was also reported that a head computed tomography on (b)(6) 2021 showed acute infarcts within the right frontal lobe and right medial cerebellar hemisphere with possible representations of petechial hemorrhage.The patient continued on appropriate anticoagulation therapies.

Manufacturer Narrative

Manufacturer's investigation conclusion: the reported events, as well as a direct correlation to the centrimag blood pump could not conclusively be determined through this evaluation.The blood pump was discarded at site and was not returned.No further issues have been reported at this time.The centrimag blood pump instructions for use (ifu) lists bleeding, arterial non-cns thromboembolism, renal dysfunction, neurologic dysfunction, and hepatic dysfunction 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 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 warning #21: use of the pump for periods longer than 30 days may result in pump failure, reduced pumping capacity, excessive blood trauma, and/or degradation of blood contact materials (with possible particles passing through the cannulae to the patient), leaks, and increased potential for gaseous emboli.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 device history record for centrimag blood pump lot #l0000008 was reviewed and showed no deviations from manufacturing or quality assurance specifications.No further information was provided.The manufacturer is closing the file on this event.

Event Description

Additional information: it was reported that the patient remained intubated secondary to respiratory failure on (b)(6) 2021 from initial temporary support and lvad implant procedure on (b)(6) 2021.The patient was extubated on (b)(6) 2021.On (b)(6) 2021, the patient was noted to have an abnormal pulse exam with radial occlusion from distal upper arm to distal forearm found on duplex arterial scan.The patient was on appropriate anticoagulation therapy at the time.The patient had slight spontaneous movement of fingers and strong multiphasic signals in rue ulnar artery.A head ct on (b)(6) 2021 showed hypoattenuation and mild mass effect seen within the left posterior limb of internal capsule and basal ganglia and an increase in conspicuity compared to prior studies and consistent with a recent infarct.Mass effect results were in 4mm of left to right midline shift.The patient showed right upper and lower extremity weakness in association to the event.Appropriate facility protocols were performed in association to the stroke events.On (b)(6)2021, the patient was noted to have new adherent thrombi along the wall of their right cervical internal carotid artery.No treatment was given.On (b)(6) 2021 the patient was noted to have increased bloody output from their orogastric tube (ogt) with melena occurring on (b)(6) 2021.An esophagogastroduodenoscopy (egd) showed large amounts of clotted blood in fundus and dieulafoy lesion.Clips were placed as appropriate but the patient continued experiencing blood output from ogt and melena stools over the following days.A repeat egd on (b)(6) 2021 showed continued bleeding with an additional clip being placed.Hemoglobin was managed as need and the patient received 16 units of blood between (b)(6) 2021 and (b)(6) 2021 when the bleeding resolved.It was also noted that the patient received 3 units of red blood cells (rbcs) on (b)(6) 2021 for appropriate hemoglobin control.On (b)(6) 2021 the patient was noted to have some changes in neurological status including necessity of increased stimuli to open their eyes, left gaze, not withdrawing with stimuli, and becoming non-verbal.Ct scan showed increased hypoattenuation in the right inferior frontal lob and anterior right insula suspect to new area of infarct.Patient glasgow coma scale (gcs) showed minimal improvement over the following 24 hours.The patient did follow movement commands as able.Facility protocol was followed for suspected brain attack.The patient was reintubated on (b)(6) 2021 due to noted decrease in neurocognitive response and altered mental status.

Manufacturer Narrative

Updated manufacturer's investigation conclusion: the reported events, as well as a direct correlation to the centrimag blood pump could not conclusively be determined through this evaluation.The blood pump was discarded at site and was not returned.The device history record for centrimag blood pump lot #l0000008 was reviewed and showed no deviations from manufacturing or quality assurance specifications.The centrimag blood pump instructions for use (ifu) lists bleeding, arterial non-cns thromboembolism, renal dysfunction, neurologic dysfunction, respiratory failure, and hepatic dysfunction 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 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 warning #21: use of the pump for periods longer than 30 days may result in pump failure, reduced pumping capacity, excessive blood trauma, and/or degradation of blood contact materials (with possible particles passing through the cannulae to the patient), leaks, and increased potential for gaseous emboli.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: 11881055
• MDR Text Key: 252610165
• Report Number: 3003306248-2021-01123
• Device Sequence Number: 1
• Product Code: KFM
• 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
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup,Followup,Followup
• Report Date: 04/07/2022

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?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/15/2023
• Device Model Number: 102953
• Device Catalogue Number: 102953
• Device Lot Number: L0000008
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: No
• Initial Date Manufacturer Received: 05/05/2021
• Initial Date FDA Received: 05/25/2021
• Supplement Dates Manufacturer Received: 08/11/2021; 12/13/2021; 02/15/2022; 03/14/2022
• Supplement Dates FDA Received: 08/17/2021; 01/07/2022; 03/01/2022; 04/07/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 09/15/2020
• 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; Hospitalization; Death
• Patient Age: 37 YR
• Patient Sex: Male
• Patient Weight: 86 KG