LIVANOVA DEUTSCHLAND S5 ROLLER PUMP; CONSOLE, HEART-LUNG MACHINE, CARDIOPULMONARY BYPASS
|
Back to Search Results |
|
Model Number 48-40-00 |
Device Problem
Pumping Stopped (1503)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 02/01/2024 |
Event Type
malfunction
|
Manufacturer Narrative
|
A.1.-a.5.There was no patient involvement.H10: livanova deutschland manufactures the s5 roller pump.The incident occurred in (b)(6) north carolina.A livanova field service representative was dispatched to the facility to investigate the device and could confirm the reported issue: pump display showed dashes and would not respond to the turning of the dial.In order to solve the issue, motor control board (hms) and motor power amplifier board (hmf) were replaced.Subsequent functional verification testing was completed without further issues and the unit was returned to service.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
|
|
Event Description
|
Livanova deutschland received a report that a s5 roller pump did not start turning and showed dashes on display, during procedure.There was no patient injury.
|
|
Search Alerts/Recalls
|
|
|