SMITHS HEALTHCARE MANUFACTURING S.A. DE C.V. SET, EXTENSION, 60", M/M, 1.7 ML, ASV 50/BX; SET, ADMINISTRATION, INTRAVASCULAR
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Catalog Number 21-7047-24 |
Device Problems
Excess Flow or Over-Infusion (1311); Air/Gas in Device (4062)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/11/2023 |
Event Type
malfunction
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Manufacturer Narrative
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A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.D4: lot number, expiration date, and h4: manufacturer date are unknown.H3: device has not been returned to manufacturer.
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Event Description
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It was reported that the pump was scheduled to finish however the pump never beeped.The pump was left to run longer but did not reach empty.Air was noted.83.30 ml was given but the cartridge was dry.No patient injury was reported.
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Search Alerts/Recalls
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