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Model Number 46113-75 |
Device Problem
Infusion or Flow Problem (2964)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 10/18/2016 |
Event Type
malfunction
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Manufacturer Narrative
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Lot review: a review of lot# 3264170 showed that (b)(4) units were manufactured, tested, inspected and released in june 2016, no exception documents were cited.
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Event Description
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Complaint received regarding one 46113-75, ped transpac iv kit w/30 ml squeeze flush device, needleless valve and 10ml contamination shield, lot# is 3264170 (mfd.06/2016).Report states; rn had a uac line that was set up and infusing.Rn tried to get a blood glucose.She turned fluids off to the patient and pulled back on the waste syringe.When slowly pulling back she noticed that she was not getting blood return and her flush syringe had air in it instead, which it had no air to begin with.After trying again and getting the same result she asked another rn to come and look at it.They retraced the lines and made sure the connections were tight.They tried drawing again and the same thing happened.They ended up getting a new uac setup and saved the one that was malfunctioning.No adverse patient consequences reported.
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Manufacturer Narrative
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Lot review: a review of lot# 3264170 showed that (b)(4) units were manufactured, tested, inspected and released in june 2016, no exception documents were cited.Receipt review: 11/3/2016 - received one used 46113-75, ped transpac iv kit w/30 ml squeeze flush device, needleless valve and 10ml contamination shield, lot# is 3264170.One used small cannula, one used tubing extension.The tubing extension was added to the squeeze flush.The small cannula was attached to the distal end of the tubing set.The device was flushed and no leaks were observed.Functional testing: unit was pressure tested and leaking was observed from a cracked female luer.Final analysis summary: the reported complaint of air entering the fluid path was confirmed.The root cause of the failure was from a cracked female luer that is consistent with environmental stress.It is unknown the cause of environmental stresses as no use conditions were reported.
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Event Description
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Complaint received regarding one 46113-75, ped transpac iv kit w/30 ml squeeze flush device, needleless valve and 10ml contamination shield, lot# is 3264170 (mfd.06/2016).Report states; rn had a uac line that was set up and infusing.Rn tried to get a blood glucose.She turned fluids off to the patient and pulled back on the waste syringe.When slowly pulling back she noticed that she was not getting blood return and her flush syringe had air in it instead, which it had no air to begin with.After trying again and getting the same result, she asked another rn to come and look at it.They retraced the lines and made sure the connections were tight.They tried drawing again and the same thing happened.They ended up getting a new uac setup and saved the one that was malfunctioning.No adverse patient consequences reported.
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Search Alerts/Recalls
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