SMITHS MEDICAL ASD, INC. LEVEL 1 HOTLINE FLUID WARMER, 390; WARMER, THERMAL, INFUSION FLUID
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Model Number HL-390 |
Device Problems
Power Problem (3010); Noise, Audible (3273)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 12/01/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Date of event is unknown; no information has been provided 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 pump shuts off after a short time running (1-2 minutes) and while it is running, it makes loud rattling noises.The issue was found during semi-annual testing, no patients or other staff were involved.
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Manufacturer Narrative
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H6 - updated one device was received for investigation.The device was visually and visually inspected.The reported complaint was confirmed as the device did not function at all.The pump was not working.This will be replaced.The product's history records were reviewed and there were no non-conformances nor service-related issues that would have resulted in the reported complaint.
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Search Alerts/Recalls
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