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Model Number B1371 |
Device Problem
Blocked Connection (2888)
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Patient Problem
Patient Problem/Medical Problem (2688)
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Event Date 03/11/2016 |
Event Type
malfunction
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Manufacturer Narrative
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Visual analysis: 4/4/2016 - received the following devices: one (1) used b1371, 8" ext set w/0.2 micron filter, luer lock, non-dehp tubing, lot# unknown; one (1) used pump cassette; one (1) used baxter iv bag.Partial device returned, the bag was cut in half.Functional/performance testing: the blood/blood clots were flushed out and decontaminated on the b1371 set.The set was then primed with water using gravity pressure (1.5 psig).And then leak tested with water at 25 psig for two (2) minutes.No leaks were found at the filter set.The one way check valve on the pump set was checked for any back flow at 1.0 psig.No leakage (back flow) was observed through the valve.The tubing pump set was tested for leaks at 10psig for one (1) minute.No leaks were found.The shut off valve also functioned shut off flow.The b1371 device was tested per the product performance specification for iv extension sets.Analysis summary: visual analysis of the "as received" used b1371 complaint sample confirmed blood/blood clots were present in the sets filter components.Following decontamination/flushing the returned sample was tested by engineering to the applicable product specifications and the device performed as intended.With the device performing as intended, the only way for the blood to back flow into the filter is if there was a deliberate disconnect in the line.
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Event Description
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Complaint received regarding one (1) b1371, 8" ext set w/0.2 micron filter, luer lock, non-dehp tubing, lot# unknown.The report states, blood back up into filter causing pump to stop.Able to flush picc with no difficulty.Neutron cap was in use.Replaced filter and line.There were no adverse patient consequences reported.
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Search Alerts/Recalls
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