Model Number SL-2010M2096 |
Device Problem
Detachment of Device or Device Component (2907)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 02/11/2022 |
Event Type
malfunction
|
Event Description
|
As reported by user facility: event 1.The line separated at the joint above the arterial pod.There was no patient involvement.
|
|
Manufacturer Narrative
|
This report has been identified as b.Braun medical inc.Internal report number (b)(4), event 1.The investigation is ongoing at this time.A follow up will be submitted when the investigation results become available.
|
|
Manufacturer Narrative
|
This report has been identified as b.Braun medical inc.Internal report number (b)(4), event 1.The investigation is ongoing at this time.A follow up will be submitted when the investigation results become available.
|
|
Event Description
|
As reported by user facility: event 1.The line separated at the joint above the arterial pod.There was no patient involvement.
|
|
Manufacturer Narrative
|
Event 1: this report has been identified as b.Braun medical internal report number (b)(4).Four (4) unopened samples and a photo of the blood tubing set were provided for evaluation.No issues were found with the returned samples.The provided photograph showed a blood tubing set with a broken arterial pod where the pod connects to the pump segment, confirming the reported issue.The photograph was provided to manufacturing for review.Manufacturing was unable to determine the root cause of this issue based on the available information.A review of the device history records for sl-2010m2096 lot 10954025 was performed and indicated that there were no quality issues during the manufacturing process of this lot related to the reported issue.A search of the complaint database for this blood tubing set lot number shows no additional complaints of damaged components as of complaint closure, indicating this is an isolated occurrence.We will maintain this report for further references and continue to monitor other reports for similar occurrences.If any additional pertinent information becomes available, a follow up will be submitted.
|
|
Search Alerts/Recalls
|