Model Number SL-2000M2095 |
Device Problem
Air/Gas in Device (4062)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 06/01/2023 |
Event Type
malfunction
|
Manufacturer Narrative
|
This report has been identified as b.Braun medical internal report number (b)(4).The investigation is ongoing at this time.A follow up will be submitted when the investigation results become available.
|
|
Event Description
|
As reported by the user facility: event 1: detailed inquiry description: the saline line that comes with the blood tubing was not pulling saline but air.When the treatment is complete, the arterial line is placed on the port on the saline line which then slowly returns the patient's blood out of the dialysis line circut.No injury reported.
|
|
Manufacturer Narrative
|
This report has been identified as b.Braun medical internal report number (b)(4).Event 1 five (5) photographs were submitted to the manufacturer for evaluation.Through visual examination, it was noted the arterial and venous lines were being used on the dialysis machine.It was difficult to determine an air in line defect with the photographs provided.Based on the investigation, the reported defect could not be observed.A review of the device history record (dhr) was performed for the reported lot number and no abnormalities or non-conformances were noted during the in process or final product inspection.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
|