Catalog Number 10015414 |
Device Problem
Backflow (1064)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 12/15/2023 |
Event Type
malfunction
|
Event Description
|
It was reported that bd alaris pump module blood set had blood backflow the following information was received by the initial reporter with the following verbatim: additional problem was noted on the same unit, a few days earlier.This event stated ¿during a transfusion, blood was backing up into the other y site line even with it clamped.We switched it out to a new set & there was no issue¿.I do not have this exact product saved, but the unit educator did grab a product from the shelf that day & saved it- so it would probably be the same batch.That lot #(10)23075418.
|
|
Manufacturer Narrative
|
E1: initial reporter facility -(b)(6) hospital h.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
|
|
Event Description
|
No additional info.
|
|
Manufacturer Narrative
|
No product or photo was returned by the customer.The customer complaint that there was back flow could not be verified due to the product not being returned for failure investigation.A device history record review for model 10015414 lot number 23075418 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 29jul2023.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.This incident has been added to our database of reported incidents.Our business team regularly reviews the collected data for identification of emerging trends.Your assistance in this matter has been helpful in trend identification and supporting our commitment to continuous quality improvement.
|
|
Search Alerts/Recalls
|