Model Number 11522558 |
Device Problem
Free or Unrestricted Flow (2945)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 05/25/2021 |
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.
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Event Description
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It was reported that the as lvp 20d 3ss cv bv ball valve malfunctioned and allowed air into the line while priming.The following information was provided by the initial reporter: "ball valve not functioning properly and allowing air in line/not keep line primed".
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Manufacturer Narrative
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H6: investigation summary.One sample (model #11522558) was returned from the customer.It was reported that the ball valve is not working properly and allowing air in line/not keep line primed.The set was examined for defects and abnormalities.No defects or abnormalities were observed.The set was primed successfully with saline.After priming, the set was drained to see where the ball would land.The ball landed where it should at the bottom of the drip chamber and did not allow air in the line.The failure was unable to be replicated, and the complaint could not be verified.A root cause was unable to be determined because the failure was unable to be replicated.A device history record review for model 11522558 lot number 20116057 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 20nov2020.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.
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Event Description
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It was reported that the as lvp 20d 3ss cv bv ball valve malfunctioned and allowed air into the line while priming.The following information was provided by the initial reporter: "ball valve not functioning properly and allowing air in line/not keep line primed.".
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Search Alerts/Recalls
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