Model Number 10010454 |
Device Problems
Leak/Splash (1354); Device Contamination with Chemical or Other Material (2944)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/02/2021 |
Event Type
malfunction
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Event Description
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It was reported that the bd gem 20d v/nv ntg.2mf 1ss dehp free experienced device damage while still considered operable.The following information was provided by the initial reporter: pt and picc checked at 2200, upon checking pt at 2300 noted tpn line to be broken and dripping onto floor.Checked picc and picc insitu, and iv tubing line had snapped at tpn filter.Lipids were y'd into line below the filter therefore lipids were still infusing into lumen.Line clamped and pump stopped.Another rn in to assist and primed d5.9ns line, tpn lines removed and lines cleansed as per cvl protocol.New line with d5.9ns connected and started.Red jr called to notify of event.Tpn put on hold for night.
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Manufacturer Narrative
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Investigation summary: no product or photo was returned by the customer.The customer complaint of component damage - leak could not be verified due to the product not being returned for failure investigation.A device history record review for model 1001045, lot number 20095932 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 07sep2020.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.Due to no sample being received, an investigation could not be performed and a root cause could not be determined.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.Due to no sample being received, an investigation could not be performed and a root cause could not be determined.No product will be returned per customer.No investigation was performed.
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Manufacturer Narrative
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Investigation summary: no product or photo was returned by the customer.The customer complaint of component damage - leak could not be verified due to the product not being returned for failure investigation.A device history record review for model 1001045, lot number 20095932 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 07sep2020.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.Due to no sample being received, an investigation could not be performed and a root cause could not be determined.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.Due to no sample being received, an investigation could not be performed and a root cause could not be determined.No product will be returned per customer.No investigation was performed.
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Event Description
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It was reported that the bd gem 20d v/nv ntg.2mf 1ss dehp free experienced device damage while still considered operable.The following information was provided by the initial reporter: pt and picc checked at 2200, upon checking pt at 2300 noted tpn line to be broken and dripping onto floor.Checked picc and picc insitu, and iv tubing line had snapped at tpn filter.Lipids were y'd into line below the filter therefore lipids were still infusing into lumen.Line clamped and pump stopped.Another rn in to assist and primed d5.9ns line, tpn lines removed and lines cleansed as per cvl protocol.New line with d5.9ns connected and started.Red jr called to notify of event.Tpn put on hold for night.
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Search Alerts/Recalls
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