Catalog Number 10010454-0006 |
Device Problem
Leak/Splash (1354)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/27/2020 |
Event Type
malfunction
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Manufacturer Narrative
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A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
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Event Description
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It was reported that the as lvp 20d low sorb ss 0.2m tubing was primed and leaked saline before separating from the pump.The following information was provided by the initial reporter: "line primed with normal saline and leaking observed.Line fell apart at joint.".
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Event Description
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It was reported that the as lvp 20d low sorb ss 0.2m tubing was primed and leaked saline before separating from the pump.The following information was provided by the initial reporter: "line primed with normal saline and leaking observed.Line fell apart at join.".
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Manufacturer Narrative
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The following fields were updated due to additional information: d.10.Device available for eval?: yes.D.10.Returned to manufacturer on: 12/15/2020.H.6.Investigation: one 10010454-0006 sample from lot 20066918 was received for investigation in opened packaging; residual fluid was present within the line.Further information provided by the customer indicates that the separation occurred from the filter immediately on priming the set.A visual inspection confirmed the customer's experience as the sample was received in two parts having separated at the tubing joint to the upper port of the in-line filter component.A closer inspection of the separated engagement identified small traces of residual solvent on the affected joint.A definitive root cause for the separation could not be determined in this instance; however it is possible that the tubing sleeve had been inadvertently expanded during the assembly process, which resulted in the tubing not correctly engaging onto the filter.This is a manual process and is likely to have occurred due to human error.A review of the production records for lot 20066918 did not identify any in-process testing failures or quality deviations which may have resulted in a report of this nature.H3 other text : see h.10.
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Search Alerts/Recalls
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