Model Number 60-01-00 |
Device Problems
Temperature Problem (3022); Noise, Audible (3273)
|
Patient Problem
No Consequences Or Impact To Patient (2199)
|
Event Date 05/23/2016 |
Event Type
malfunction
|
Manufacturer Narrative
|
Patient information was not provided.Sorin group (b)(4) manufactures the sorin centrifugal pump system with tubing clamp.The incident occurred in (b)(6).This medwatch report is filed on behalf of sorin group (b)(4).Sorin group (b)(4) received a report that the pump of sorin centrifugal pump system with tubing clamp became warm and produced noise during a procedure.There was no report of patient injury.A sorin group field service representative was dispatched to the facility to investigate.The service representative confirmed the reported issue and identified a faulty gasket connector.The part was replaced and functional testing identified no further issues.The unit was released to the customer and the replaced part was scrapped.The investigation is ongoing.A follow-up report will be sent when the investigation is complete.Discarded by 3rd-party service engineer.
|
|
Event Description
|
Sorin group (b)(4) received a report that the pump of sorin centrifugal pump system with tubing clamp became warm and produced noise during a procedure.There was no report of patient innjury.
|
|
Manufacturer Narrative
|
Livanova (b)(4) manufactures the centrifugal pump system with tubing clamp.The incident occurred in (b)(6).This medwatch report is being filed on behalf of livanova (b)(4).The involved device was returned to livanova (b)(4) for further investigation and repair.The device was cleaned, disinfected and the insert for the clamp was replaced.A technical safety inspection was successfully completed before the device was returned to the customer.A review of the dhr did not identify any deviations or non-conformities relevant to the reported issue.
|
|
Search Alerts/Recalls
|