Model Number 2420-0500 |
Device Problems
Leak/Splash (1354); Material Separation (1562)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/05/2022 |
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 experienced component separation with leakage.The following information was provided by the initial reporter: tubing near patient (not close to the pump) came apart and sprayed venofer on pt's arm and pillow.
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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.Device expiration date: unknown.
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Event Description
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It was reported that the bd alaris¿ pump module smartsite¿ infusion set experienced component separation with leakage.The following information was provided by the initial reporter: tubing near patient (not close to the pump) came apart and sprayed venofer on pt's arm and pillow.
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Manufacturer Narrative
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H6: investigation summary: a photo was received from the customer with the complaint of separation.The separation is clearly presented in the tubing to male luer portion of the set.This verifies the complaint.Without further information or the physical sample for further testing, the root cause of this issue remains unknown.A device history record review for model 2420-0500 lot number 22053139 was performed.The search showed that a total of 34,563 units in 1 lot number was built on 18may2022.There were no quality notifications issued for the failure mode reported by the customer during the build of this set.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.H3 other text : see h.10.4.
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Search Alerts/Recalls
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