SMITHS MEDICAL ASD, INC. LEVEL 1 HOTLINE BLOOD AND FLUID WARMER; WARMER, THERMAL, INFUSION FLUID
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Catalog Number HL-90 |
Device Problem
Low Readings (2460)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/08/2023 |
Event Type
malfunction
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Manufacturer Narrative
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H3 - other: device has not been returned to date.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 was consistently reading approximately 1.3 degrees celsius below other similar devices and a calibrated temperature probe.There was no patient involvement.No patient harm/adverse event reported.
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Manufacturer Narrative
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After further review, the reported event does not meet the requirements for a reportable malfunction.Failure to heat the fluid to the normothermic temperature would not likely lead to serious injury or death.Therefore, the mdr can be cancelled.
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Search Alerts/Recalls
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