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THORATEC SWITZERLAND GMBH CENTRIMAG BLOOD PUMP; PUMP, BLOOD, CARDIOPULMONARY BYPASS, NON-ROLLER TYPE
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| Model Number 102953 |
| Device Problems
Mechanical Problem (1384); Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Bacterial Infection (1735); Stroke/CVA (1770); Hemolysis (1886); Hemorrhage/Bleeding (1888); Hemothorax (1896); Thrombosis/Thrombus (4440); Aspiration Pneumonitis (4455); Lactate Dehydrogenase Increased (4567)
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| Event Date 04/13/2021 |
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Event Type
Injury
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Manufacturer Narrative
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No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed the heartmate 3 lvas was implanted during the momentum 3 clinical trial, ide# (b)(4).Fda approval for heartmate 3 lvas was received on 23 august 2017.The gtin unique device identifier for the commercial heartmate3 lvas is (b)(4).
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Event Description
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It was reported that the patient received 1 unit of red blood cells on (b)(6) 2021 for bleeding with increased oozing around tracheostomy on (b)(6) 2021.Patient experienced hemoglobin drop to 7.0.The patient experienced infection on (b)(6) 2021.The patient was started on intravenous antibiotic administration on (b)(6) 2021 following multiple days of leukocytosis.Cultures that were taken found to be positive for micrococcus species (suspected to be skin flora).The patients central venous catheter was removed.The event resolved without sequelae on (b)(6) 2021.The patient was given 1 unit of red blood cell on (b)(6) 2021 for generalized hemoglobin management.The goal was to keep the hemoglobin values above 7.0.The source of bleeding was not specified.The patient was given another unit of red blood cell on (b)(6) 2021 for continued hemoglobin management.The patient underwent a exploratory laparotomy procedure with noted pneumatosis seen on abdominal computed tomography scan on (b)(6) 2021.The patient experienced continued bleeding following procedure and 4 red blood cell units were given.The patient was started on intravenous antibiotic therapies on (b)(6) 2021 following noted pneumatosis/enteritis on computed tomography scan alongside increasing lactate.The patient received 3 units of red blood cells on (b)(6) 2021 with noted excessive bleeding coming from the patients driveline exit site.The patients centrimag pump was replaced on (b)(6) 2021 due to device thrombus.The patient experienced decreasing hemoglobin levels below 8 on (b)(6) 2021 with associated anemia.This required hemoglobin replenishment and the patient was given 1 unit of red blood cells on (b)(6) 2021.The patient experienced hemolysis on (b)(6) 2021.Patient was noted to have increasing lactate dehydrogenase labs with a value on 1163 units/liter, 1222 units/liter and 1462 units/liter from (b)(6) 2021-(b)(6) 2021.The patient had increasing plasma free hemoglobin with a level of 65.1 milligrams/deciliter on (b)(6) 2021.And 126.5 milligrams/deciliter on (b)(6) 2021.The patient required hemoglobin management with consistent decrease in hemoglobin lab values.The patient was in ongoing/stable condition at time of the event.
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Event Description
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It was reported that the patient experienced decreasing hemoglobin to below 7.5 on (b)(6) 2021 with suspected multifactorial sources.Hemoglobin (hgb) management was necessary since the patient was on anticoagulation.1 unit of red blood cells (rbcs) was given on (b)(6) 2021.The patient had a psychiatric episode and was started on appropriate medication.Hemolysis resolved without sequelae on (b)(6) 2021.The patient received 1 unit of rbcs on (b)(6) 2021 for continued hemoglobin management.Chest computed tomography (ct) scan on (b)(6) 2021 showed bilateral pleural effusions.Bilateral chest tubes were placed with thick purulent drainage output following placement.The patient was started on intravenous antibiotic therapy.Abdominal ct scan taken on (b)(6) 2021 showed evidence of acute cholecystitis, gall bladder distension and thickening, and increasing lipase and lactate.The patient was started on intravenous antibiotics.The patient was given 6 units of rbcs on (b)(6) 2021, 2 units on (b)(6) 2021, 1 unit on (b)(6) 2021, 1 unit on (b)(6) 2021, 3 units between (b)(6) 2021-(b)(6) 2021 following thrombectomy procedure, and 1 unit on (b)(6) 2021 due to multifactorial causations and due to the team wanting to keep hgb above 7.5.The patient experienced increased output from around right and left chest tubes following placement on (b)(6)2021.A arterial non-central nervous system thromboembolism was noted on (b)(6) 2021.A chest computed tomography (ct) scan on (b)(6) 2021 showed evidence multiple pulmonary emboli with patient requiring increased oxygen (venous thromboembolism noted).Abdominal ct scan taken on (b)(6) 2021 showed evidence of acute cholecystitis, gall bladder distension and thickening, and increasing lipase and lactate.The patient was started on intravenous antibiotics.On (b)(6) 2021, the patient was started on tissue plasminogen activator/dornase regimen as appropriate for occlusion prophylaxis and was given 4 units of rbcs.The patient underwent video-assisted thoracoscopic surgery on (b)(6) 2021 for hemothorax removal.They were given 1 unit of rbcs during procedure.The bleeding continued following procedure with increased hemorrhaging.The patient then received an additional 2 units of red blood cells with returned back to the operating room for exploration purposes on (b)(6) 2021.The patient returned to the operating room again on (b)(6) 2021 and (b)(6) 2021 for continued exploration and washout.Chest closure was carried out with the patient receiving 6 units of red blood cells during the procedures.A total 9 units of rbcs were given between (b)(6) 2021-(b)(6) 2021.
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Manufacturer Narrative
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No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.
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Event Description
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It was reported that the patient experienced neurologic dysfunction on (b)(6) 2021.It was noted that the patient was following commands less and less over previous days alongside less spontaneous movement.The patient had a computed tomography scan of head completed which showed parafalcine subdural hematoma, left tentorial subdural hematoma, and left temporoparietal subarachnoid hemorrhage.The event resolved without sequelae on (b)(6) 2021.
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Manufacturer Narrative
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No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.
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Manufacturer Narrative
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No further information was provided.A supplemental report will be submitted when the manufacturer¿s investigation is completed.
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Event Description
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Related manufacturer report number: 3003306248-2021-04024.It was reported that the patient received 2 units red blood cells on (b)(6) 2021, 2 units on (b)(6) 2021, and 1 unit on (b)(6) 2021 due to bleeding.A thrombectomy procedure was performed on (b)(6) 2021 to address venous thromboembolism.The patient experienced continued epistaxis from (b)(6) 2021 and was given nasal packing.The patient experienced increasing white blood cell count on (b)(6) 2021 with positive resulting beta-d glucan.The patient was started on intravenous antibiotic therapies.The patient was started on intravenous antibiotic therapies as appropriate on (b)(6) 2021.A hepatobiliary iminodiacetic acid scan done on (b)(6) 2021 indicated suspected acute cholecystitis with gall bladder wall thickening.The patient was started on empiric intravenous antibiotics with chole drain placement done on (b)(6) 2021.The patient experienced continued epistaxis on (b)(6) 2021 with otorhinolaryngology being consulted.The patient was given 1 unit of red blood cells on (b)(6) 2021 for continued epistaxis.The patient's labs resulted positive for enterobacteria cloacae on (b)(6) 2021.The patient was given 1 unit of red blood cells on (b)(6) 2021 following suspected pull on chole drain and decrease in hemoglobin with additional suture being placed.Computed tomography imaging also showed hemoperitoneum near uterus with possible association to drain placement.The patient was given 1 unit of red blood cells on (b)(6) 2021 and (b)(6) 2021 in association to decreasing hemoglobin.The cause of decreasing hemoglobin was unclear but it was speculated to be multifactorial.
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Manufacturer Narrative
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The investigation conclusion and codes for reported events occurring after (b)(6) 2021 will be captured in related manufacturer report number: 3003306248-2021-04024.Manufacturer's investigation conclusion: the evaluation of the returned centrimag blood pump, lot number l0000004, confirmed the report of device thrombosis.In addition, a direct correlation between the centrimag device and the reported bleeding, infection, hemorrhagic stroke, and psychiatric episode could not be conclusively established through this evaluation.The centrimag blood pump, lot number l0000004, was returned with tubing secured to the inlet and outlet ports with zip ties.Examination of the outlet tubing attached to the pump revealed small red depositions where the tubing interfaced with barbed connectors.These depositions were not adhered to the blood contacting surface and did not show evidence of denaturation.A large red thrombus formation was observed surrounding the blades of the rotor and extending down one side of the rotor body.Upon removal of the thrombus formation from the blood pump, the thrombus appeared to have a fibrous, stringy structure.The thrombus was not adhered to the blood-contacting surfaces and did not show any evidence of denaturation.The evaluation could not conclusively determine a specific cause for the development of the observed thrombus formations, their origin, or a duration of time for which they were present in the blood pump; however, the thrombus formations would have contributed to the report of elevated ldh and plasma free hemoglobin.No depositions or thrombus formations were observed on the bottom of the rotor body, within the rotor well, or within the inlet and outlet ports.Visual examination of the blood pump revealed no evidence of damage to the pump housing or the inlet/outlet ports.Visual inspection of the pump rotor following removal of the thrombus did not reveal any evidence of damage or wear.Examination of the rotor well revealed no evidence of separation or slippage between the rotor magnet and rotor body.Following cleaning, microscopic inspection of the blood pump revealed no anomalies.The blood pump was functionally tested on a mock circulatory loop and functioned as intended in accordance with manufacturing specification.Review of the device history record (dhr) for the centrimag blood pump, lot # l0000004 revealed no deviations from manufacturing or quality assurance specifications.The centrimag blood pump instructions for use (ifu) (rev.09) lists bleeding, infection, hemolysis, and psychiatric episode 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 #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.
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Event Description
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It was reported that the patient was given 1 unit of red blood cells on (b)(6) 2021, (b)(6) 2021 and (b)(6) 2021 due to decreasing hemoglobin.Patient re-consulted with psychiatry group on (b)(6) 2021 for continued medication management.The patient was reintubated on (b)(6) 2021 for hypoxia and hypercapnia due to increased pulmonary edema.Bronchoscopy was performed which showed no signs of obstruction.The patient was extubated on the morning of (b)(6) 2021.The event resolved without sequelae on (b)(6) 2021.The patient expressed necessity of increase respiratory support with persistent opacities and pleural effusions being seen in chest imaging.The patient was started on antibiotic therapies with suspect of possible pneumonia.Pleural fluid was taken on (b)(6) 2021 which resulted positive for enterococcus faecalis with continuation of antibiotics as appropriate.The infection resolved on (b)(6) 2021.It was reported that on (b)(6) 2021, (b)(6) 2021, and (b)(6) 2021 the patient was given one unit of red blood cells in association to decreasing hemoglobin below 7.On (b)(6) 2021 the patient was noted to have increased ventricular response in the 130s with concern of tachycardia (unclear if ventricular or supraventricular).The patient was given intravenous (iv) magnesium and lidocaine bolus and demonstrated an appropriate response.On (b)(6) 2021 the patient received a chest x-ray that exhibited an interval increase in bilateral opacities with more heterogeneous opacity in the right lower lung.The patient had sputum cultures taken with resulting gram positive rod and coccus on (b)(6) 2021.The patient was started on iv antibiotic therapies as appropriate.On (b)(6) 2021 antibiotics were discontinued after infection resolved.
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