Catalog Number 2420-0007 |
Device Problem
Defective Component (2292)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 03/04/2024 |
Event Type
malfunction
|
Manufacturer Narrative
|
H.3.If a device evaluation and/or device history review is completed, a supplemental report will be filed.
|
|
Event Description
|
It was reported that bd alaris pump module smartsite infusion set was damaged the following information was received by the initial reporter with the following verbatim occluded.Upon replacing the lipid filter, the clear crew broke off the regular fluid line, making the line unusable.Required smof lipids to be paused and discarded.Rn will now need to access the central lines multiple times to replace ine using sterile technique.Patient will now go a few hours without smof running.Meds given: smoflipid fat emulsion 20% - 20gm in 100ml - 2.34 ml/hr total vol.: 100ml also make sure to use our choc report number for all communication.
|
|
Manufacturer Narrative
|
No product or photo was returned by the customer.The customer complaint of lipid filter issues could not be verified due to the product not being returned for failure investigation.Device history record review for model 2420-0007 lot number 24015098 was performed.The search showed that a total of (b)(4) units in 1 lot number was built on 8jan2024.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.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.
|
|
Event Description
|
No additional information was provided.
|
|
Search Alerts/Recalls
|