LIVANOVA DEUTSCHLAND S5 DOUBLE HEAD PUMP; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
|
Back to Search Results |
|
Model Number 10-85-00 |
Device Problem
Material Rupture (1546)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 09/20/2022 |
Event Type
malfunction
|
Event Description
|
Livanova received report that a s5 double head pump had a blood leak due to hemocon tube breakage.There was no patient injury.
|
|
Manufacturer Narrative
|
There was no patient involvement.Livanova deutschland manufactures the s5 double head pump.The incident occurred in sapporo, hokkaido, japan.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
|
|
Event Description
|
See initial report.
|
|
Manufacturer Narrative
|
Livanova received a report regarding a blood leakage caused by the "hemocon" tube breakage during its usage with s5 double roller pump.The issue occurred during the procedure and did not affect the patient.The s5 double roller pump unit was sent back to livanova.The field service technician tested the unit as per specification without finding any failure: no sharp points were found on rollers and tubing guide rollers, the movement of rollers and tubing guide rollers were smooth and no sticking was detected, the functional test found no deviation and the unit was put back into service.Review of the livanova complaints database did not identify any other similar event since unit installation in 2017.Based on the investigation results, the most likely root cause of the reported issue can be traced to the "hemocon" disposable tube (not livanova device) or to an over occlusion set by the customer (user error).Reportability decision change to not reportable event based on the fact that livanova device did not contribute to the reported tubing rupture and can be excluded as cause of the event.The risk is in the acceptable region.No corrective action is deemed necessary.Livanova will keep monitoring the market.
|
|
Search Alerts/Recalls
|
|
|