Catalog Number AMC9668 |
Device Problems
Obstruction of Flow (2423); Material Deformation (2976); Protective Measures Problem (3015)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/14/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Should additional relevant information become available, a supplemental report will be submitted.
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Event Description
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It was reported that an unspecified infusion pump displayed an alarm ¿obstruction in the infusion flow¿ while being used with a continu-flo solution set.Upon further inspection, ¿it was observed that the valve of the faulty device had a protuberance on the upper part¿.This was observed during setup and preparation.There was no patient involvement.No additional information is available.
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Manufacturer Narrative
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Device manufactured on january 2021.The actual device was not available; however, a retained sample was evaluated.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.A gravity testing via methylene blue and leak testing was performed; no leak was observed.The reported condition was not verified.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.
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Search Alerts/Recalls
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