Model Number 531157-32A |
Device Problems
Crack (1135); Fluid/Blood Leak (1250); Chemical Problem (2893); Device Handling Problem (3265)
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Patient Problems
Awareness during Anaesthesia (1707); Inadequate Pain Relief (2388)
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Event Type
malfunction
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Manufacturer Narrative
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Event took place in (b)(6), actual date of the event is unknown.As soon as further information becomes available and as soon as the investigations have been finished a follow up report will be sent.
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Event Description
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(b)(4).Tentative summarizing translation from user's narrative: when connecting the filter to the infusion line it cracked.Had to be replaced.
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Manufacturer Narrative
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Based on risk assessment and clinical evaluation file is considered as closed.
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Event Description
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(b)(4).Date of event still unknown.Tentative summarizing translation from user's narrative: when connecting the filter to the infusion line it cracked.Had to be replaced.Two (2) filters involved.
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Search Alerts/Recalls
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