|
Catalog Number 627193402 |
Device Problem
Component Misassembled (4004)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Type
malfunction
|
Event Description
|
Livanova usa inc has received a report that the position of the clamp colors in the cardioplegia kit being used were incorrect when compared with the pack specification sheet.In details, both red clamps were on the small tubing side and both white clamps are on the large tubing side.According to the perfusionist, as a consequence, the content of a bag of high potassium (k) was delivered into the reservoir despite having both white clamps closed.This occurred prior to the cardiopulmonary bypass, so it had no impact on the patient.There is not report of any patient injury.
|
|
Manufacturer Narrative
|
There was no patient involvement.Event date is unknown.The device was disposed by the customer.Livanova usa manufactures the smart cardioplegia.The incident occurred in (b)(6) united states of america.The device was disposed by the customer.However, a photographic evidence confirming the misassembly was provided by the customer.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.Disposed by the customer.
|
|
Manufacturer Narrative
|
Livanova received a report stating that during setup, the customer noted that the positions of colored clamps on the cardioplegia kit were incorrect.The result of this incorrect position of the clamp colors was the draining of a bag of high k into the reservoir.This occurred prior to the cardiopulmonary by-pass, therefore it had no impact on the patient.A clear picture of the misassembly was provided by the customer, confirming the issue.Sample was not available because it was thrown away after the case.The dhr review highlighted that the lot whose claimed product belong to was released as conform according to specifications.For this pts pack code is not foreseen a 100% inspection.A review of the complaints database did not reveal further similar event occurred on this pts pack code or concerned batch.Based on the above facts, most likely root cause of the reported event was due to manufacturing operator error during the assembly phase of this pts.The manufacturing personnel will be involved in a dedicated training meeting to discuss the customer complaint.The risk is in the acceptable region.No other corrective action is deemed necessary.Livanova will keep monitoring the market.
|
|
Event Description
|
See initial report.
|
|
Search Alerts/Recalls
|
|
|