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Catalog Number 81570 |
Device Problems
Overheating of Device (1437); Improper Flow or Infusion (2954); Excessive Heating (4030)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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Since an overheating insert could necessitate medical/surgical intervention to preclude permanent damage to a body structure or permanent impairment of a body function, this malfunction would be likely to cause/contribute to a serious injury should it recur.As such, this event meets the criteria for reportability per 21 cfr part 803.The device is available for evaluation, though results are not available as of this report.Evaluation results will be submitted as they become available.
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Event Description
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In this event it is reported that 30k fsi-sli-1000 insert, pkd allegedly the insert heats up even after turning the power down and increasing water flow.No injury was reported.
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Manufacturer Narrative
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Visually inspected and verified the insert is good, no fault found.Also insert was tested on a digital thermometer i.D.#(b)(4) due date: (b)(6) 2023.The temperature was 86.5°, no fault found.The specification states are not to exceed 118.4°f.
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Search Alerts/Recalls
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