SMITHS MEDICAL ASD, INC. LEVEL 1 FAST FLOW FLUID WARMER; WARMER, BLOOD, NON-ELECTROMAGNETIC RADIATION
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Catalog Number 8002950 |
Device Problems
Insufficient Flow or Under Infusion (2182); Improper Flow or Infusion (2954); Pumping Problem (3016)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/16/2024 |
Event Type
malfunction
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Manufacturer Narrative
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H3: other; device not returned to manufacturer.Investigation including root cause analysis is in progress.A supplemental mdr will be filed as necessary in accordance with 21 cfr 803.56 when additional reportable information becomes available.
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Event Description
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It was reported that the device took 30 minutes to infuse blood to the patient.When biomed tested the unit, it passed with saline.There was patient involvement, but no patient harm/adverse event reported.
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Search Alerts/Recalls
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