Model Number 2426-0007 |
Device Problems
Leak/Splash (1354); Loose or Intermittent Connection (1371)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/03/2023 |
Event Type
malfunction
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Event Description
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It was reported that the bd alaris¿ pump module smartsite¿ infusion set tubing had a loose connection and started leaking medication during use.This occured with 5 sets.The following information was provided by the initial reporter: "tubing is coming " loose at connection and start leaking medication." no patient harm reported as a result.There have been 5 insistences so far.".
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Manufacturer Narrative
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Date of event: unknown.The date received by manufacturer has been used for this field.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
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Event Description
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It was reported that the bd alaris¿ pump module smartsite¿ infusion set tubing had a loose connection and started leaking medication during use.This occured with 5 sets.The following information was provided by the initial reporter: "tubing is coming " loose at connection and start leaking medication." no patient harm reported as a result.There have been 5 insistences so far.".
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Manufacturer Narrative
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H6: investigation summary no product or photo was returned by the customer.The customer complaint of loose component - leak could not be verified due to the product not being returned for failure investigation.A device history record review for model 2426-0007 lot number 23019088 was performed.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.
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Search Alerts/Recalls
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