Catalog Number ABC2707 |
Device Problems
Obstruction of Flow (2423); Protective Measures Problem (3015)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 08/25/2020 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(6).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 a solution set was occluded after the chamber.This was observed when the medication was added and the infusion started.It was further reported the set was connected to an unspecified infusion pump and the pump displayed an ¿occlusion above¿ alarm.There was no patient injury or medical intervention associated with this event.No additional information is available.
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Manufacturer Narrative
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H10: the actual device was not available; however, ten retained samples were evaluated.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.A functional testing was not performed for this complaint.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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