Model Number D1000 |
Device Problems
Air Leak (1008); Fluid/Blood Leak (1250); Leak/Splash (1354)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Type
malfunction
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Manufacturer Narrative
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A review of the mfg.Lot database for the reported lot# 3255850 (mfg.05/2016) showed (b)(4) units were mfg.Tested, inspected and released.There were no exception documents generated during the lot build.Pending receipt of involved and / same lot samples.Pending receipt of devices.
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Event Description
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Int'l ((b)(6) ) complaint received reporting leakages (blood/air) issues with use of d1000 tego connectors.The initial information received reports approximately five occurrences where tego connectors in use for one day were ".Leaking air and blood".There were no reported patient injuries and or adverse outcomes.Additional event information although requested by the mfr has not been provided.
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Manufacturer Narrative
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The involved tego connectors were not returned for analysis and confirmation.(b)(4) packaged d1000 tego connectors (none from the reported lot# 325580 and one from lot# 3246196) were received.Engineering analysis and investigation: the returned d1000 tego connectors were each pressure leak tested.The results recorded (b)(4) of the tego connectors leaked, failed pressure leak tests.Findings: the reported leakage issue was replicated and confirmed with (b)(4) of the returned complaint samples.Corrective and preventative actions: a detailed analysis of the tego design, materials, manufacturing and inspection processes and equipment was performed.The data and engineering efforts identified the root cause(s) to be a seal component anomaly attributable to the manufacturing /molding operation involving a cavity core pin edge.Corrective actions have been identified, qualified and implemented.Additionally, icu medical has initiated and is recalling those lots that could potentially contain this condition.
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Event Description
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Int'l.((b)(4)) complaint received reporting leakages (blood/air) issues with use of d1000 tego connectors.The initial information received reports approximately five occurrences where tego connectors in use for one day were ".Leaking air and blood".There were no reported patient injuries and or adverse outcomes.Additional event information although requested by the mfr.Has not been provided.This is the mfr's follow up report to provide additional information and the device return investigation results/findings.
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Search Alerts/Recalls
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