Model Number 16-02-80 |
Device Problems
Insufficient Cooling (1130); Fluid/Blood Leak (1250)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Date 03/24/2021 |
Event Type
malfunction
|
Manufacturer Narrative
|
There was no patient involvement.The heater-cooler 16-02-80 is not distributed in the usa and it is similar to heater-cooler 16-02-85, which is distributed in the usa (510(k) number: k191402).Livanova (b)(4) manufactures the heater-cooler system 3t.The incident occurred in (b)(6).Livanova initiated an investigation.If any additional information pertinent to the reported event is received, it will be provided in a supplemental report.
|
|
Event Description
|
Livanova (b)(4) received a report that a heater-cooler system 3t device was leaking water from the ventilation grill during priming.The amount of water is unknown at this time and a massive leak cannot be excluded.There was no patient involvement.
|
|
Manufacturer Narrative
|
Event has been updated following to additional information received revealing that the event was not related to a water leak and it was related to a cooling malfunction.A livanova field service representative was dispatched to the facility to investigate the device and could confirm the reported issue.The failure was traced back to a damaged compressor.The device will not be repaired.
|
|
Event Description
|
Livanova deutschland received a report that a heater-cooler system 3t device was leaking water from the ventilation grill during priming.The amount of water is unknown at this time and a massive leak cannot be excluded.There was no patient involvement.Additional information revealed that the event was not related to a water leak.Here below the updated event description: livanova deutschland received a report that a heater-cooler system 3t device was not cooling during priming.There was no patient involvement.
|
|
Search Alerts/Recalls
|