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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 Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problems
Arrhythmia (1721); Hemorrhage/Bleeding (1888); Unspecified Infection (1930); Tachycardia (2095); Respiratory Failure (2484); Heart Failure/Congestive Heart Failure (4446); Renal Impairment (4499)
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| Event Date 03/12/2021 |
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Event Type
Injury
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Event Description
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It was reported that the patient was given one unit of packed red blood cells due to a bleeding event on (b)(6) 2021 which brought their hemoglobin level to below 7.5 g/dl.This occurred following chest closure and right ventricular assist device decannulation the previous day.The event resolved without sequelae within the same day.On (b)(6) 2021, the patient experienced an infection with symptoms of increased white blood cell count and fever.Blood culture labs were positive for beta d glucan.The patient was started on antibiotic therapies.On (b)(6) 2021, the patient was started on renal replacement therapies following inadequate urinary output, increasing creatinine, and decreased response to diuretic therapies.On (b)(6) 2021, the patient was given another unit of red blood cells due to decreasing hemoglobin.The team wanted to keep the patient's hemoglobin level above 7.5 g/dl.The source of the bleeding was not specified.On (b)(6) 2021, the patient was reintubated following worsening respiratory failure with increased hypercapnia and hypoxia.Following intubation, the patient had a bronchoscopy done with the removal of a mucus plug.That same day, the patient underwent placement of a right ventricular assist device (rvad) due to continued respiratory distress following intubation, alongside a high dose of inotropic and vasopressor support.Also on (b)(6) 2021, the patient experienced increased ectopy with ventricular tachycardia.The incident was resolved without sequelae through administration of lidocaine bolus with continuous drip (gtt).On (b)(6) 2021, the patient was given another unit of red blood cells following rvad placement and decreasing hemoglobin to 7.0 g/dl.It was reported that the patient had respiratory cultures taken on (b)(6) 2021 resulting on (b)(6) 2021 with positive yeast/gram positive cocci/enterococcus faecium.Patient was started on appropriate intravenous (iv) antibiotic therapy coverage for resulting labs.Blood cultures on (b)(6) 2021 resulted negative.Iv antibiotic was discontinued on (b)(6) 2021.The patient was extubated on (b)(6) 2021.The patient was given 2 units of rbcs on (b)(6) 2021 for downtrending hgb to 6.4 g/dl.Suspected from chest tube output.On (b)(6) 2021, patient lactate dehydrogenase (ldh) lab resulted over 2.5 times the hospital normal range limit with continuing value trend over multiple days.The patient did not express any other clinical indications of associated symptoms.Patient currently on rvad and lvad support systems at time of increased ldh labs.On (b)(6) 2021, patient experience extended but stable ventricular tachycardia (vt) antitachycardia pacing was initiated with no response or resolution.The patient was given commanded shock with rhythm conversion.The patient later experienced recurrent vt during night time.Lidocaine drip was initiated and the vt resolved.The patient received 3 units of red blood cells (rbcs) between dates of (b)(6) 2021 and (b)(6) 2021 due to decreasing hemoglobin values and providing team wanting to keep hemoglobin (hgb) above 7.5 g/dl.The patient continued to experienced chest tube output.Labs taken following reintubation and aspiration event in previous days.On (b)(6) 2021, patient was reintubated due to worsening multifocal/multilobar consolidative opacities with near complete consolidation of portions of lobes.Following, patient had bronchoscopy performed with removal of thick secretions.On (b)(6) 2021 the patient received 2 units of packed rbcs due to the decreasing hemoglobin value to 6.4 g/dl with patient experiencing increased epistaxis.Patient has nasal packed and balloon placed on (b)(6) 2021.The patient received 2 units rbcs over the period of (b)(6) 2021 to (b)(6) 2021 with decreasing hgb below 7.5 g/dl.The source of the bleed was believed to be multi-factoral with patient having bloody secretions from wound sites and tubings and continued epistaxis.On (b)(6) 2021 the patient received another 2 units of rbcs for decreasing hgb to 6.9 following trach placement procedure with continued nasal and oral bleeding and bloody secretions as suspected source.
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Event Description
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It was reported that the patient continued to experience decreased chest tube output.Patient transitioned to tracheostomy on (b)(6) 2021.On (b)(6) 2021, inpatient psychiatry consult was completed with the patient experiencing continued anxiety and suspected depression.The patient was started on diazepam along with current medication optimization.The patient received 1 unit of red blood cells (rbc) on (b)(6) 2021.Bleeding continued to be multifactorial from expistaxis and oral bleeding.Patient received 1 rbc unit on (b)(6) 2021.On (b)(6) 2021, the patient experienced sustained ventricular tachycardia with commanded shock given and the patient received multiple anti-arrhythmic intravenous (iv) medication boluses and started on glucose tolerance test (gtt) therapies.On (b)(6) 2021, the patient experienced cardiac arrhythmias and implantable cardioverter-defibrillator (icd) shock was delivered, along with iv therapies.On (b)(6) 2021, pneumonia was suspected and patient beta-d-glucan lab resulted positive with correspondence to continued opacities of lungs per imaging.Patient started on fungal iv antibiotic therapies.Patient chest imaging showed increased fluid collection around the left ventricular assist device (lvad) outflow graft and driveline with increasing white blood cells (wbc).Patient later had positive labs on (b)(6) 2021 and (b)(6) 2021 for unspecified yeast with continuation of antibiotic.Patient had positive cultures result on (b)(6) 2021 for enterococcus faecium taken from bronchoalveolar lavage sample.Suspected association with opacified chest imaging.Patient started on specified iv antibiotic therapies following resulted lab.
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Event Description
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It was reported that on (b)(6) 2021 the patient received 2 units of red blood cells (rbcs) with decreasing hemoglobin below 7.5 g/dl.The source of the bleed was believed to be multifactorial with the patient having bloody secretions from wound sites/tubings and continued epistaxis.The patient received an additional 2 units of rbcs on (b)(6) 2021 for decreasing hemoglobin to 6.9 g/dl following tracheostomy placement procedure with continued nasal/oral bleeding and bloody secretions.On (b)(6) 2021, the patient required another 2 units of red blood cells (rbcs).On (b)(6) 2021, the patient received 1 unit of rbcs with a decrease in hemoglobin to 7.2 g/dl.The patient received an additional 3 units of rbcs on (b)(6) 2021 for a drop in hemoglobin below 7.5 g/dl.The patient experienced extended ventricular tachycardia on (b)(6) 2021 with decreasing rvad flows.The patient was given multiple iv antiarrhythmic boluses with glucose tolerance test therapies of amiodarone and procainamide started.On (b)(6) 2021, the patient received 1 unit of rbcs for drop in hemoglobin.On (b)(6) 2021, the patient received a cardioversion for sustained ventricular tachycardia.On (b)(6) 2021, an abdominal ct scan showed a new wedge-shaped hypodensity in spleen suspective of splenic infarct.The patient also experienced increased central venous pressure with noted ascites on (b)(6) 2021.The patient was started on iv inotropic support.
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Event Description
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On (b)(6) 2021 the patient received (b)(4), unit of red blood cells (rbcs) for drop in hemoglobin.There was no specific source for bleeding noted.On (b)(6) 2021, the patient experienced a seizure which resolved after being administered lorazepam.A computed tomography (ct) was performed which showed remote infarcts involving left cerebellum and bilateral superior/frontal posteroparietal lobes.The patient was started on keppra.On (b)(6) 2021 the patient was febrile with increasing white blood cell count.A sputum culture was taken which resulted positive for methicillin-susceptible staphylococcus aureus (mssa).The patient was started on intravenous (iv) antibiotic therapy.1 unit of rbcs was also given on (b)(6) 2021 for a drop in hemoglobin.There was no specific source for bleeding noted.On (b)(6) 2021 the patient was noted to have maroon bowel movements with clots.The patient underwent an esophagogastroduodenoscopy procedure with blood clot and ulcerations noted in the transverse colon/splenic flexure area which is suggestive of ischemia.There was no change in hemoglobin noted and no red blood cells were given at the time of event discovery.The patient experienced continued suspected extravasation and 3 rbc units were given between (b)(6) 2021-(b)(6) 2021.On (b)(6) 2021, the patient was experiencing hyperglycemia with suspicions of infection.Blood culture was taken which was positive for enterobacter yeast candida albicans on (b)(6) 2021 with suspected line relation.The patient was started on iv antifungal on (b)(6) 2021.
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Event Description
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It was additionally reported that on (b)(6) 2021, the patient returned to the operating room for continued mediastinal hemorrhaging with intended chest exploration.The patient received 3 red blood cell (rbc) units between (b)(6) 2021 and (b)(6) 2021 prior to re-exploration procedure.The patient received 2 additional rbc units on (b)(6) 2021 following the chest re-exploration.The patient also received 4 rbc units between (b)(6) 2021 and (b)(6) 2021 with patient experiencing continued blood output of mediastinal chest tube (greater than 2 liters over a 24 hour period).
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Manufacturer Narrative
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Manufacturer's investigation conclusion: a direct correlation between the reported events and the centrimag device could not be conclusively established through this evaluation.Multiple attempts were made to obtain additional information from the customer regarding the event and the device return status; however, no additional information was provided.The centrimag device has not been returned for evaluation at this time.The centrimag blood pump instructions for use (ifu) (rev.09) lists bleeding, infection, cardiac arrhythmia, neurologic dysfunction, hemolysis, psychiatric episode, arterial non-cns thromboembolism, and multiple types of organ failure and dysfunction (renal dysfunction, respiratory failure, and right heart failure) as adverse events that may be associated with the centrimag circulatory support system.This ifu also provides the following warnings and cautions: warning 7: it is intended that systemic anticoagulation be utilized while the 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 #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.Review of the device history record (dhr) for the centrimag blood pump, lot # l06829-la5 (document dhr cm pump l06428-la8) revealed no deviations from manufacturing or quality assurance specifications.No further information was provided.The manufacturer is closing the file on this event.
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