DEROYAL INTERCONTINENTAL, S.L. R ,KMS, AUTOPISTA JOAQUIN BALAGUER HEATED HI-FLOW INSFFULATION TUBING; INSUFFLATON TUBING, TBING W/ FILTER
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Catalog Number 28-0212H |
Device Problems
Device Operates Differently Than Expected (2913); Infusion or Flow Problem (2964); No Flow (2991)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 03/21/2012 |
Event Type
malfunction
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Event Description
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Customer contacted deroyal sales rep and stated that the tubing "would not flow".
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Manufacturer Narrative
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This report is being filed due to a retrospective review of complaints.This complaint has been re-opened for further investigation.A supplemental report will be filed if further investigation provides information which changes the content of this report.The original root cause was determined to be migration of the plasticizer into the filter housing.It was determined to change the filter material to a polycarbonate material which is stronger, higher impact, and more chemical resistant.It is also less affected by temperature.
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Search Alerts/Recalls
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