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Model Number 21-7361-24 |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problems
Fever (1858); Chills (2191); Shaking/Tremors (2515)
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Event Date 04/09/2021 |
Event Type
malfunction
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Event Description
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It was reported the device was in use for saline hydration infusion.The reporter stated the device was found leaking.Reporter stated before leakage was detected patient showed symptoms of muscle pains, cramping, fever, chills and shaking.Reporter received replacement devices with no adverse effects reported.
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Manufacturer Narrative
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This remediation mdr was generated under protocol (b)(4).As a result of warning letter cms (b)(4).Corrected data: h10: a device history review (dhr) was conducted, which indicated all inspections were completed.And no issues were noted, during manufacture.
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Search Alerts/Recalls
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