Model Number 106524US |
Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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Patient Problems
Bacterial Infection (1735); Skin Infection (4544)
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Event Date 06/13/2022 |
Event Type
Injury
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Manufacturer Narrative
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Manufacturer's investigation conclusion: the pump remains in use supporting the patient.A correlation between the device and the report of infection could not be conclusively determined.Infection is listed in the instructions for use as a potential adverse event that may be associated with the use of heartmate 3 left ventricular assist system.Infection has been previously investigated and will continue to be monitored through quality data reviews, which are conducted on production and post product signals to evaluate if products are conforming to product requirements.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 fell after tripping over the driveline in the middle of the night on (b)(6) 2022.The patient was prophylactically on doxycycline on (b)(6) 2022.At the patient's follow up appointment it was noted that the driveline exit site was clean and dry.On (b)(6) 2022 the patient was seen by infectious disease and reported new drainage with increased pain and edema at the driveline exit site.Cultures were obtained and were positive for corynebacterium.The patient was started on oral daptomycin with no improvement, so they were given a peripherally inserted central catheter (picc) line and started on iv daptomycin for four weeks.Blood cultures as of (b)(6) 2022 were negative.The patient's statin was put on hold.The patient was to be discharged pending insurance approval for their at home antibiotics.
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Manufacturer Narrative
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No further information was provided.The manufacturer is closing the file on this event.
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Event Description
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Additional information was received that the patient was readmitted in (b)(6) 2022 and was found to have a corynebacterium driveline infection.The patient was switched from daptomycin to linezolid and from doxycycline to minocycline.On (b)(6) 2022 blood cultures were positive for acinetobacter ursingi and the infection was treated with tigecycline, cefepime, and daptomycin while inpatient.The patient was then transitioned to oral linezolid and ciprofloxacin for two weeks.Suppression of corynebacterium and acinetobacter was done with bactrim (sulfamethoxazole-trimethoprim) and doxycycline.
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Search Alerts/Recalls
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