Model Number 2477-0007 |
Device Problem
Leak/Splash (1354)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/08/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Medical device expiration date: unknown.A device evaluation and/or device history review is anticipated, but is not complete.Upon completion, a supplemental report will be filed.Device manufacture date: unknown.(b)(4).
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Event Description
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It was reported that as lvp bld180m 15d ss tubing came apart.The following information was provided by the initial reporter: event 2: material#: 2477-0007, lot#: unknown.It was reported that the tubing came apart below the drip chamber.Verbatim: while infusing unit of blood, tubing came apart right below the drip chamber.Blood was wasted.
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Manufacturer Narrative
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H.6.Investigation: no photo or sample was received for investigation.The customer's complaint of leakage could not be verified.A device history record review could not be performed because a lot number was not provided by the customer.Due to no sample being received, the root cause of this failure remains unknown.
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Event Description
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It was reported that as lvp bld180m 15d ss tubing came apart.The following information was provided by the initial reporter: event 2: material#: 2477-0007, lot#: unknown.It was reported that the tubing came apart below the drip chamber.Verbatim: while infusing unit of blood, tubing came apart right below the drip chamber.Blood was wasted.
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Search Alerts/Recalls
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