Catalog Number 11532269 |
Device Problem
Leak/Splash (1354)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/29/2024 |
Event Type
malfunction
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Manufacturer Narrative
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H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
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Event Description
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It was reported that bd alaris pump module smartsite low sorbing infusion set was leaking the following information was received by the initial reporter with the following verbatim: the small first filter portion of the set developed a leak.There was no patient injury.
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Manufacturer Narrative
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No product or photo was returned by the customer.The customer complaint of leakage could not be verified due to the product not being returned for failure investigation.A device history record review could not be performed on material 11532269 because the lot number is unknown.Due to no sample being received, an investigation could not be performed, and a root cause could not be determined.
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Event Description
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No additional info.
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Search Alerts/Recalls
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