Catalog Number 2426-0500 |
Device Problem
Infusion or Flow Problem (2964)
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Patient Problem
No Consequences Or Impact To Patient (2199)
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Event Date 11/25/2020 |
Event Type
malfunction
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Manufacturer Narrative
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(b)(6) hospital.Device expiration date: unknown.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.Device manufacture date: unknown.(b)(4).
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Event Description
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It was reported that the gem v/nv 20dp ckv 2ss 117-in 20pk experienced tubing expansion/ballooning.The following information was provided by the initial reporter: complaint 2 of 2.Material #: 2426-0500, lot#: unknown.Rn reported that the tubing herniated when the start button was pushed on the alaris pump when starting a new infusion.The rn saw it immediately and was able to stop the infusion and able to set up a new tubing set.
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Event Description
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It was reported that the gem v/nv 20dp ckv 2ss 117-in 20pk experienced tubing expansion/ballooning.The following information was provided by the initial reporter: complaint 2 of 2.Material#: 2426-0500, lot#: unknown.Rn reported that the tubing herniated when the start button was pushed on the alaris pump when starting a new infusion.The rn saw it immediately and was able to stop the infusion and able to set up a new tubing set.
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Manufacturer Narrative
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Investigation summary: one sample was received for quality investigation.The customer complaint that the tubing herniating was confirmed by visual inspection.The silicone tubing was noticeably deformed in shape from the failure that the customer reported.No further damages or defects were observed.A device history record review could not be performed on model 2426-0500 because a lot number was not provided by the customer.The root cause of this failure can be attributed to a failure of the component.The sample was able to prime and infuse without issues, and therefore it is determined that the silicone tubing failed.
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Search Alerts/Recalls
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