Catalog Number 955404 |
Device Problem
Temperature Problem (3022)
|
Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
|
Event Type
malfunction
|
Manufacturer Narrative
|
Should additional relevant information become available, a supplemental report will be submitted.
|
|
Event Description
|
It was reported that during treatment at the dialysis unit with an ak98 control unit, an alarm related to the temperature not reaching sufficient temperature during disinfection was generated.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
|
|
Manufacturer Narrative
|
The device was evaluated on site by a qualified technician.The technician observed a leak coming from the degassing chamber and replaced it.The technician performed a clean cart disinfection and the machine was returned to back to clinical use.A service history review revealed no indication that the parts replaced during servicing caused or contributed to the reported event.Should additional relevant information become available, a supplemental report will be submitted.
|
|
Search Alerts/Recalls
|