Catalog Number 2420-0007 |
Device Problem
Improper Flow or Infusion (2954)
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Patient Problem
Hypersensitivity/Allergic reaction (1907)
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Event Date 02/14/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Medical device expiration date: unknown.Device manufacture date: unknown.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¿ lvp 20d 2ss cv flow issues occurred.There was no report of patient impact.The following information was provided by the initial reporter: it was reported by the customer medication back-flowed.Verbatim: biomed called to report a 8100 pump and alaris tubing issue.Medication back-flowed.Customer is willing to return defective product for investigation.
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Event Description
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It was reported while using bd alaris¿ lvp 20d 2ss cv flow issues occurred.There was no report of patient impact.The following information was provided by the initial reporter: it was reported by the customer medication back-flowed.Biomed called to report a 8100 pump and alaris tubing issue.Medication back-flowed.Customer is willing to return defective product for investigation.
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Manufacturer Narrative
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H.6.Investigation summary: a photo was submitted by the customer for quality investigation.The customer complaint of infection / irritation / inflammation / allergic reaction, flow issue - back flow could not be verified due to the product not being returned for failure investigation and the photo of the product not being the product reported in the complaint.A device history record review could not be performed because the lot number is unknown.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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