Model Number 4103202 |
Device Problems
Fluid/Blood Leak (1250); Leak/Splash (1354)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Type
malfunction
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Manufacturer Narrative
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Investigation is still underway.A follow up medwatch will be submitted if additional information becomes available.The event occurred in an ous country.The device is sold bulk non-sterile to oem manufacturers.This medwatch has been submitted because a similar device is marketed by quest medical in the us.
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Event Description
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A report received from a customer states that the device leaked during priming.
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Manufacturer Narrative
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The complaint sample was evaluated and the root cause for the leaking valve is improper handling of the umbrella valve during the assembly proces.Corrective actions implemented at quest to prevent recurrence of this issue include issuing a quality alert to manufacturing personnel; updating the assembly process to include instructions for preventing this defect; use of a digital flow tester and 100%inspection using the digital flow tester.
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Search Alerts/Recalls
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