Catalog Number 20350E |
Device Problems
Leak/Splash (1354); Separation Problem (4043)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/10/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Date of event is unknown: the date received by manufacturer has been used for this field.Medical device expiration date: unknown.Device manufacture date: unknown.Device evaluated by mfr: 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 while using bd alaris smartsite low sorbing extension set disconnection occurred which led to leakage.There was no report of patient impact.The following information was provided by the initial reporter: customer stated the tubing disconnected from filter which caused a chemo spill.
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Event Description
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It was reported while using bd alaris smartsite low sorbing extension set disconnection occurred which led to leakage.There was no report of patient impact.The following information was provided by the initial reporter: customer stated the tubing disconnected from filter which caused a chemo spill.
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Manufacturer Narrative
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Investigation summary no product or photo was returned by the customer.The customer complaint of tubing disconnected at the filter could not be verified due to the product not being returned for failure investigation.A device history record review could not be performed because the material and lot number are unknown.The root cause of this failure could not be identified without a failure investigation.
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Search Alerts/Recalls
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