Catalog Number 114749 |
Device Problem
Device Contamination with Chemical or Other Material (2944)
|
Patient Problem
No Patient Involvement (2645)
|
Event Date 10/21/2020 |
Event Type
malfunction
|
Manufacturer Narrative
|
(b)(6).Should additional relevant information become available, a supplemental report will be submitted.
|
|
Event Description
|
It was reported that a particulate matter was observed inside the cap of a revaclear 400 dialyzer during priming.There was no patient involvement.No additional information is available.
|
|
Manufacturer Narrative
|
H10: the actual device and sample photo were received for evaluation.The visual inspection of the provided photo showed an overview of the product.Neither a particulate matter nor another failure was visible on the photo.The visual inspection by naked eye of the product showed the product wet.A particulate matter was not visible on neither the blood nor in the dialysate side.The reported condition was not verified.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.
|
|
Search Alerts/Recalls
|