SMITHS MEDICAL ASD, INC. LEVEL 1 LOW FLOW - HOTLINE FLUID WARMER; WARMER, THERMAL, INFUSION FLUID
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Model Number HL-90 |
Device Problem
Failure to Pump (1502)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/28/2024 |
Event Type
malfunction
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Event Description
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It was reported that the pump failed.The issue was not related to damage/abuse, nor was the unit dropped.There was no patient involvement and no patient harm/adverse event reported.
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Manufacturer Narrative
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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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Manufacturer Narrative
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Evaluation codes: updated.Device evaluation: one device was returned for investigation.Visual inspection found: enclosure cracked under quick connect, corroded quick connect, and outdated quick connect, pcb, and power switch.Functional testing confirmed the complaint.Root cause was attributed to a faulty pump.The service history review identified there was no indication that the complaint was related to a service of the device within the review period.No action taken due to the condition of the device.It is deemed beyond economical repair and will be scrapped.
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Search Alerts/Recalls
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