Catalog Number 2420-0500 |
Device Problems
Leak/Splash (1354); Material Puncture/Hole (1504)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/21/2023 |
Event Type
malfunction
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Manufacturer Narrative
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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 leaked saline from a pin hole in the pumping segment of the line.The following information was provided by the initial reporter: "bd alaris infusion pump set.The nurse primed the line.I entered the room when the pump was alarming (not connect to patient yet) and saw fluid squirting out of a pin hole on the silastic pumping segment.No medication ¿ the line was primed with 0.9% saline and the pi hole was discovered.Duration of the leak? it was noted almost immediately after line was primed.The infusion pump was not damaged.".
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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 pinhole leak in the pumping segment could not be verified due to the product not being returned for failure investigation.Device history record review for model 2420-0500 lot number 23015147 was performed.There were no quality notifications issued for the failure mode reported by the customer during the production build of this set.The root cause of this failure could not be identified without a failure investigation.
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Event Description
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It was reported that the bd alaris¿ pump module smartsite¿ infusion set leaked saline from a pin hole in the pumping segment of the line.The following information was provided by the initial reporter: "bd alaris infusion pump set.The nurse primed the line.I entered the room when the pump was alarming (not connect to patient yet) and saw fluid squirting out of a pin hole on the silastic pumping segment.No medication : the line was primed with 0.9% saline and the pi hole was discovered.Duration of the leak? it was noted almost immediately after line was primed.The infusion pump was not damaged.".
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Search Alerts/Recalls
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