Model Number 944-157 |
Device Problem
Leak/Splash (1354)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/09/2020 |
Event Type
malfunction
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Manufacturer Narrative
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The solution pack was used in a abl90 flex plus analyzer (item no.393-092, serial no.(b)(4).
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Event Description
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According to the complaint the user found a lot of liquid leakage from the solution pack(sp) several days after the 90sp was installed.Nobody touched the leaked liquid directly.The sp contained contaminated blood.
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Manufacturer Narrative
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G4: corrected data: device is not a combination product.H3: the concerned solution pack was available to be returned to radiometer for investigation purposes, but as the solution pack contained contaminated blood it was disassembled at distributor site and pictures of this was used at radiometer investigation.H6: component code has not been filled out as the root cause investigation indicates that the device did not malfunction.For the radiometer investigation investigator checked production documentation e.G.The production journal.Logbook's related to ready good productions process was verified.None of them were linked to registered complaint.Reference samples were also checked and reference sample was mounted in accordance to specification.The finalized radiometer investigation identified the root cause for the event as a waste pouch component issue and also the process of assembly at the radiometer production site.To solve the complaint issue the user/customer shall change the solution pack to a new solution pack.
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Search Alerts/Recalls
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