Model Number 10013361 |
Device Problem
Material Twisted/Bent (2981)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/24/2023 |
Event Type
malfunction
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Manufacturer Narrative
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Device evaluated by mfr: a device evaluation and/or device history review is anticipated but is not complete.Upon completion, a supplemental report will be filed.
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Event Description
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It was reported while using bd alaris pump module smartsite infusion set the tubing was kinked.There was no report of patient impact.The following information was provided by the initial reporter: defective due to tubing being crimped/bent right at the drip chamber.
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Event Description
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It was reported while using bd alaris pump module smartsite infusion set the tubing was kinked.There was no report of patient impact.The following information was provided by the initial reporter: defective due to tubing being crimped/bent right at the drip chamber.
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Manufacturer Narrative
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The following fields were updated due to additional information: d10: device available for eval yes.D10: returned to manufacturer on: 03-feb-2023.H6: investigation summary a complaint of drip chamber being kinked was received from the customer.9 unused and 2 used samples were returned for investigation.Through visual inspection, the customer complaint was confirmed.1 used and 2 unused samples were kinked right at the drip chamber connection site to the tubing.1 used and 7 of the unused samples were kinked a little below the connection site on the tubing.A device history record review for model 10013361 lot number 21125226 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.A review of the manufacturing process was performed in order to verify the current controls and to identify the potential root cause regarding the failure mode reported.With the use of a cause-and-effect diagrams, it was determined that the root cause for this failure is excessive time in an assembly fixture, causing these kinks.
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Search Alerts/Recalls
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