Model Number 46101-98 |
Device Problems
Leak/Splash (1354); Output Problem (3005)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 04/27/2017 |
Event Type
malfunction
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Manufacturer Narrative
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Pending receipt of device.
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Event Description
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Complaint received reporting air in lines with use of 46101-98 nicu safeset w/tp4 squeeze flush; needleless valve mtg.Kit.The initial information received reports there have been three incidents where ".Air is entering the line after the kit is properly primed and while on a patient.The issues were detected with loss of / dampened waveforms, monitor alarmed and visually.This was noted mostly in and around the transducer.".The devices were removed and replaced.There were no reported adverse patient consequences.Additional event/device information was requested but as of the date of this report no responses have been received.
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Manufacturer Narrative
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Device return: two (2) packaged 46101-98 nicu safeset mtg.Kit; lot# 3396971 and one packaged mating device baxter clearlink continu-flo set with duo-vent spike, model 2c8551 s.Engineering testing and analysis: the returned packaged 46101-98 mtg kit same lot samples were each tested to the applicable product specifications which includes leak, vacuum and restriction testing.The results recorded no performance issue(s) and or out of spec conditions.Additional testing: each of the 46101-98 mtg.Kits were connected to the returned baxter clearlink set and functionally tested including pressure and vacuum testing.The results recorded no leakages, no performance and or functional issues.The set-ups met the acceptance criteria.Findings: testing and analysis of the two returned 46101-98 mtg.Kit packaged same lot samples recorded no functional and or out of spec conditions.The mfger.Was unable to replicate or confirm the reported product issue with the unused same lot samples.At this time, the exact cause(s) of the product issue is unknown.The mfger.Will continue to monitor and trend these types of reported product issues and initiate preventative measures as applicable.
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Event Description
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Complaint received reporting complaint received reporting air in lines with use of 46101-98 nicu safeset mtg.Kit, lot# 3396971.The information received reports there have been three incidents where ".Air is entering the line.".This was detected visually and when loss of and/or dampened waveforms occurred and monitor alarms.The devices were removed and replaced.There were no reported adverse patient consequences.This is the mfgers.Follow up report to provide additional information and device return investigation findings.
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Search Alerts/Recalls
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