Model Number 106015 |
Device Problem
Mechanical Problem (1384)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/11/2022 |
Event Type
malfunction
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Manufacturer Narrative
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No further information was provided.A supplemental report will be submitted once the manufacturer¿s investigation is completed.
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Event Description
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It was reported that there was a concern that there could be an issue with the driveline as the patient had rescue tape and a few breaks in the line.The log files did not contain any evidence of a driveline issue.
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Event Description
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It was reported that new black rescue tape was placed to the area of concern on the driveline and discussed with the patient about the potential for fractured wire over time including pump stops, neither of which the patient had at the time of the event.
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Manufacturer Narrative
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The patient had prior damage to driveline as reported under mfr #2916596-2021-05969.Manufacturer's investigation conclusion: the report of superficial damage to the silicone jacket of the patient¿s driveline could not be confirmed through this evaluation as no images were submitted for review and the patient remains ongoing on ventricular assist device (vad) support.The submitted log file contained data from 04jun2022 to 11jul2022.The pump operated above the low speed limit for the duration of the log file.There were no atypical pump related alarms and the log file appeared to show the system operating as intended.The patient remains ongoing on ventricular assist device (vad) support with no further related issues reported at this time.Review of the device history records showed no deviations from manufacturing or qa (quality assurance) specifications.The heartmate ii lvas instructions for use (ifu) is currently available.The section entitled ¿pump performance monitoring¿ under patient care and management covers wear and tear to the driveline.Heartmate ii lvas patient handbook is currently available.Section 4 of this handbook contains information on ¿caring for the driveline.¿ however, all hmii lvad drivelines have the potential for wire/shield breakdown to occur dependent upon length of use and movement/flexing over time.No further information was provided.The manufacturer is closing the file on this event.
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Search Alerts/Recalls
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