Model Number 72404310 |
Device Problems
Break (1069); Loose or Intermittent Connection (1371)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/22/2018 |
Event Type
Injury
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Manufacturer Narrative
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Reservoir 65ml pc: (b)(4).
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Event Description
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It was reported that the pump and reservoir replacement due to pump connector breakage and new reservoir connection(old one is still in the patient's body).No injury to the patient was reported due to this event.
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Manufacturer Narrative
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Reservoir 65ml pc: gtin# (b)(4).Upn# unk-m-72404161.
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Event Description
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It was reported that the pump and reservoir replacement due to pump connector breakage and new reservoir connection(old one is still in the patient's body).No injury to the patient was reported due to this event.Additionally it was noted that there was crack on the plastic windows connector piece.No other patient symptoms were reported.
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Manufacturer Narrative
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An overall investigation conclusion code of cause not established was chosen as the investigation findings confirmed there was a leak in the system due to contamination in the pump, however, the source of the fluid leak could not be identified with components that were returned.The event cannot be reproduced or substantiated and the product analysis did not confirm a product failure; therefore, no escalation to ncep, capa, or scar is required.Reservoir 65ml pc: gtin# (b)(4).Upn# (b)(4).
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Event Description
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It was reported that the pump and reservoir replacement due to pump connector breakage and new reservoir connection(old one is still in the patient's body).No injury to the patient was reported due to this event.Additionally it was noted that there was crack on the plastic windows connector piece.No other patient symptoms were reported.
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Search Alerts/Recalls
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