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
Atrial Fibrillation (1729); Hemolysis (1886); Hemorrhage/Bleeding (1888); Tachycardia (2095)
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Event Date 04/27/2021 |
Event Type
Injury
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Event Description
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It was reported that the patient had cardiac arrhythmia after blood pump was implanted on (b)(6) 2021.Amiodarone and magnesium was administered on (b)(6) 2021 for atrial fibrillation and ventricular tachycardia which returned the patient to normal sinus rhythm with continued tachycardia/fibrillation runs following.Baseline digoxin was started (b)(6) 2021 and atrial fibrillation was ongoing the next day with amiodarone dops started.On (b)(6) 2021 , the patient was noted to be tearful, confused, and agitated which require seroquel psychosocial management.Medications were optimized on (b)(6) 2021 for psychiatric episode.The patient was given 1 unit of red blood cells on (b)(6) 2021 for hemoglobin management keeping it above 7.5.No source of bleeding was noted.
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Manufacturer Narrative
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Manufacturer's investigation conclusion: a specific cause for the reported cardiac arrhythmias, psychiatric episode and bleeding episodes, as well as a direct correlation to the centrimag blood pump could not conclusively be determined from this evaluation.Per additional information from the biomedical engineer, the centrimag blood pump is no longer in use.The pump will not be returned as the patient was taken off support approximately 3 months ago.The patient is no longer supported by centrimag blood pump lot number l00000-13.No product is available for investigation.The device history records for centrimag blood pump lot number l00000-13 were reviewed and showed no deviations from manufacturing or quality assurance specifications.The centrimag blood pump us instructions for use lists bleeding, cardiac arrhythmias and psychiatric episode as adverse events that may be associated with the use of the centrimag circulatory support system.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.Warning 10: frequent patient and device monitoring is recommended.Warning 15: a backup centrimag pump, console, motor and accessories should be available for use.No further information was provided.The manufacturer is closing the file on this event.
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