Catalog Number 2420-0500 |
Device Problem
Leak/Splash (1354)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/06/2024 |
Event Type
malfunction
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Event Description
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It was reported that bd alaris pump module smartsite infusion set was leaking the following information was received by the initial reporter with the following verbatim: type of incident/problem: malfunction - during or after use level of harm: no apparent harm - reached patient/person, inconvenient ahs optional report to cmdsnet (health canada): yes incident details: nurse was assessing connections on all iv's at 2300.Prior assessment was done at 2000, all lines secure and attachments connected.The isoproterenol line was loose and leaking fluid in the bed.Nurse attempted to reconnect the iv tubing to stop cock but the luer connector completely disconnected from line, fell off of the iv tubing and into bed.Unable to reattach line as it was completely broken.Nurse had to spike bag with new tubing.Impact of incident: patient was a critically unstable icu patient had an interruption to continuous isoproterenol infusion and became hypotensive.Who was affected? patient.
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Manufacturer Narrative
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H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
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Manufacturer Narrative
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No product or photo was returned by the customer.The customer complaint of luer connector complete disconnection could not be verified due to the product not being returned for failure investigation.A device history record review could not be performed on material 2420-0500 because the lot number is unknown.The root cause of this failure could not be identified without a failure investigation.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.Your assistance in this matter has been helpful in trend identification and supporting our commitment to continuous quality improvement.
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Event Description
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No additional information was provided.
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Search Alerts/Recalls
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