Model Number 2420-0007 |
Device Problem
Defective Device (2588)
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Patient Problem
Insufficient Information (4580)
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Event Date 06/12/2023 |
Event Type
malfunction
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Manufacturer Narrative
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H.3.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 damaged.There was no report of patient impact.The following information was provided by the initial reporter: xxx had an alaris infusion set ref# (b)(4) lot# (10)23025547 that broke during usage.Our cath lab reported that ¿when spiking a bag of ns with pump tubing, the tubing came off of the drip chamber¿ on (b)(6) 2023.The product was not saved for evaluation, but i wanted to report the failure for tracking and trending.
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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 damaged.There was no report of patient impact.The following information was provided by the initial reporter: had an alaris infusion set ref#: 2420-0007, lot#: (10)23025547 that broke during usage.Our cath lab reported that ¿when spiking a bag of ns with pump tubing, the tubing came off of the drip chamber¿ on (b)(6) 2023.The product was not saved for evaluation, but i wanted to report the failure for tracking and trending.
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Manufacturer Narrative
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Investigation summary: no product or photo was returned by the customer.The customer complaint of tubing defective/damaged could not be verified due to the product not being returned for failure investigation.A device history record review for model: 2420-0007, lot number: 23025547 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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