Model Number LXT |
Device Problem
Partial Blockage (1065)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 03/29/2019 |
Event Type
malfunction
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Manufacturer Narrative
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Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.The manufacturer internal reference number is: (b)(4).
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Event Description
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A customer reported that lot of bubble occurred after opening the infusion tubing head and bubbles occurred again when flushed using liquid when the gas-liquid change ended.No patient harm.
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Manufacturer Narrative
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Supplemental medical device report # 01, is being filed as it was determined that manufacturing report number 2028159-2019-00567 was a duplicate of mdr number 2028159-2019-00667.Additional information will be provided under manufacturer number 2028159-2019-00667.The manufacturer internal reference number is: (b)(4).
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Event Description
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New information from affiliate indicates that this report is a duplicate of a previous file.
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Search Alerts/Recalls
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