Model Number 2423-0007 |
Device Problems
Leak/Splash (1354); Device Damaged Prior to Use (2284)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/27/2022 |
Event Type
malfunction
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Event Description
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It was reported that 3 bd alaris pump module smartsite infusion sets experienced device damage while still considered operable, and leakage.The following information was provided by the initial reporter: there is a leak/crack in the clips on the tubbing, allowing there to be leaking of fluid down the tube.
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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.Initial report facility name: (b)(6).Device evaluated by mfr: 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 3 bd alaris pump module smartsite infusion sets experienced device damage while still considered operable, and leakage.The following information was provided by the initial reporter: there is a leak/crack in the clips on the tubbing, allowing there to be leaking of fluid down the tube.
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Manufacturer Narrative
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Investigation summary: a complaint of tubings clips being damaged was received from the customer.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 2423-0007 lot number 22066424 was performed.The search showed that a total of (b)(4) units in 1 lot number were built on (b)(6) 2022.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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