Model Number D1000 |
Device Problem
Air Leak (1008)
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Patient Problems
Patient Problem/Medical Problem (2688); No Known Impact Or Consequence To Patient (2692)
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Event Date 08/08/2016 |
Event Type
malfunction
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Manufacturer Narrative
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Pending receipt of involved devices.
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Event Description
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Int'l.((b)(6)) complaint received reporting air in lines with use of unspecified dialysis set-up where d1000 tego connectors were in use.The initial information received describes the event as follows ".Tego changed as per weekly procedure and air noted in line and foam in arterial chamber tego changed, situation was resolved".There were no reported adverse patient consequences.
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Manufacturer Narrative
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Device return: one used d1000 tego connector visual inspection (pre and post decontamination) of the as-received tego connector recorded internal residual blood was observed between the body and seal sheath.Engineering testing and analysis to the applicable product specification was performed.The results recorded leakage.Additional pressure leak testing was performed to evaluate the integrity of the body/seal interface.The results recorded leakage/failure.The tego connector was than dissassembled to perform additional analysis of the internal componentry.The results recorded internal damages at the body - seal interface.This condition could result in internal leakage.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 seal/body component anomaly was 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 air in lines with use of unspecified dialysis set-up where d1000 tego connectors were in use.The initial information received describes the event as follows ".Tego changed as per weekly procedure and air noted in line and foam in arterial chamber tego changed, situation was resolved".There were no reported adverse patient consequences.This is the mfr's follow up report to provide additional information and the device return investigation results.
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Search Alerts/Recalls
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