Catalog Number 361546 |
Device Problem
Incorrect, Inadequate or Imprecise Result or Readings (1535)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 08/24/2018 |
Event Type
malfunction
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Manufacturer Narrative
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Date of event: unknown.The date received by manufacturer has been used for this field.(b)(4).(b)(6).A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.
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Event Description
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It was reported that bd sedi-40¿ produced an error message and would not function.No serious injury or medical intervention was reported.
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Event Description
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It was reported that bd sedi-40¿ produced an error message and would not function.No serious injury or medical intervention was reported.
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Manufacturer Narrative
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H.6.Investigation: investigation summary: bd had performed a technical evaluation of the customer's sedi-40 instrument.It was determined that the sprocket that is mounted to the tube holder had loosened itself and was not driving the tube holder anymore.Due to the fact that it is not mixing it will generate in most cases llo since partial sedimentation was already started.Subsequently the instrument was repaired.Upon completion of the instrument evaluation, the service technician had verified that the instrument was operating within normal parameters, as documented in the instrument service report.Investigation conclusion: based on evaluation of the customer's instrument, the customer's observation of llo error message was acknowledged.Root cause description: the root cause was attributed to a hardware component that drives the tube holder and mixing process.Rationale: complaints received for this device and reported condition will continue to be tracked and trended.Information will be captured on trend reports and monitored.The bd business team regularly reviews the collected data for identification of emerging trends.
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Search Alerts/Recalls
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