Model Number 21-7600-24 |
Device Problems
Fluid/Blood Leak (1250); Leak/Splash (1354)
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Patient Problems
No Consequences Or Impact To Patient (2199); No Information (3190)
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Event Date 05/18/2020 |
Event Type
malfunction
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Event Description
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Information was received that during use of this smiths medical cadd cassette reservoirs, the customer noticed medical fluid leaking from where the cassette's connector and extension tube connected.No reported adverse effects or patient injury.
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Manufacturer Narrative
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Investigation completed on a smiths medical ambulatory infusion pumps|cadd cassette reservoirs - flow stop.Samples returned p/n 21-7600-24 manufactured with the lot 3883724 in not its original packaging.Visual inspections under procedure ?visual inspection? md01-003 rev.102 revealed no discrepancies.When functional testing was down to infuse water the complaint was verified.All manufacturing process was reviewed.Root cause investigation and corrective actions will be follow by capa process, through capa-000713 open on september 22nd 2020.By the date that this investigation report is documented capa-000713 is under investigation phase.The expected due date of this investigation phase is november 23rd.
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Event Description
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Investigation completed on a smiths medical pumps|cadd cassette reservoirs - flow stop.
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Search Alerts/Recalls
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