HEARTWARE, INC. HEARTWARE VENTRICULAR ASSIST SYSTEM - DRIVELINE; VENTRICULAR (ASSISST) BYPASS
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Device Problem
Material Split, Cut or Torn (4008)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/01/2021 |
Event Type
Injury
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Manufacturer Narrative
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Product event summary: a pump with unknown serial number was not returned for evaluation.Review of the manufacturing documentation could not be performed since the device serial number was unknown.Review of the controller log files was not performed since log files covering the reported event date were not available for analysis.The reported event could not be confirmed due to insufficient evidence.A splice repair was performed to mitigate the reported event.Based on the available information, the reported event may be attributed to improper handling.This event was reported in the q3 2021 intermacs data registry that tracks clinical outcomes of patients on ventricular assist device (vad) support.The data registry does not contain device identifying information or event date and therefore cannot be correlated to any previously received report of the event.Based on the provided data, device analysis will not be possible and no further information will likely be made available concerning the event.If information is provided in the future, a supplemental report will be issued.
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Event Description
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It was reported that the patient was admitted after completely severing the ventricular assist device (vad) driveline.The patient was reportedly using an automobile automatic buffer and when he moved the buffer in a downward motion against the car, it caught his driveline and cut it completely in half.An engineer was able to splice a new driveline and the patient was fairly asymptomatic.During the time that the patient was in the emergency room and the pump was off, the patient was given heparin and milrinone.These medications were stopped after the driveline was repaired and the pump was turned back on.The patient was monitored overnight.The vad remains in use.No further patient complications were reported as part of the event.This event was reported in the q3 2021 intermacs data registry that tracks clinical outcomes of patients on ventricular assist device (vad) support.The data registry does not contain device identifying information or event date and therefore cannot be correlated to any previously received report of the event.Based on the provided data, device analysis will not be possible and no further information will likely be made available concerning the event.
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Search Alerts/Recalls
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