Catalog Number 382-10 |
Device Problem
Improper Flow or Infusion (2954)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 09/12/2020 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(4).
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Event Description
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The complaint is reported as: two more columns turned in for increased volumes in pc or drop in pip in prvc.Same two lots.The patient is losing volumes in pressure ventilation.They change the column to a 382-30 and problem solved.There was no patient harm reported.No medical intervention was required.The patient's condition is reported as fine.
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Event Description
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The complaint is reported as: two more columns turned in for increased volumes in pc or drop in pip in prvc.Same two lots.The patient is losing volumes in pressure ventilation.They change the column to a 382-30 and problem solved.There was no patient harm reported.No medical intervention was required.The patient's condition is reported as fine.
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Manufacturer Narrative
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(b)(4).Complaint verification testing could not be performed as no sample was returned for analysis.A device history record review could not be performed as the lot number reported by the customer is not valid.Without the device to evaluate the complaint could not be confirmed and the probable cause could not be determined from the available information.Teleflex will continue to monitor and trend for reports of this nature.If the sample becomes available at a later date a follow up report will be submitted with investigation results.
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Search Alerts/Recalls
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