SMITHS MEDICAL ASD, INC. LEVEL 1 HOTLINE FLUID WARMER, 390; WARMER, THERMAL, INFUSION FLUID
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Model Number HL-390 |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/01/2024 |
Event Type
malfunction
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Event Description
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It was reported that the unit was leaking.The malfunction was found during preventive maintenance.No patient harm/adverse event reported.
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Manufacturer Narrative
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B3: date of event and d5: operator of device are unknown, no information has been provided to date.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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Manufacturer Narrative
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H6 - updated.Device evaluation: no product was returned for investigation.Therefore, we are unable to determine the reported complaint.If we receive the device, we will reopen the investigation for further evaluation.However, based on the reported problem, the most probable cause is a cracked tank cover and/or a cracked tank by the drain tube fitting.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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