InjuryKDL
CUSTODIOL HTK SOLUTION
Received Jun 25, 2021 · Event occurred Jun 8, 2021
Report MW5102155 · MDR key 12075025
Device
Generic name
Set, Perfusion, Kidney, Disposable
Lot number
2021872
Product problems
- Adverse Event Without Identified Device or Use Problem
Patient
55 YR
- Insufficient Information
- Insufficient Information
Narrative
Description of Event or Problem
THE RISK MANAGEMENT DEPARTMENT WAS MADE AWARE ON 06/17/2021 OF A SERIES OF PATIENTS THAT HAVE EXPERIENCED UNEXPECTED OUTCOMES STATUS POST TRANSPLANT SURGERY THAT OCCURRED THE WEEK OF (B)(6) 2021. THE PATIENT EXPERIENCED AN UNEXPECTED ADVERSE EVENT AFTER A KIDNEY TRANSPLANT FROM A LIVE DONOR. WHEN THE TEAM COMPARED SIMILARITIES THE COMMONALITY IS THE USE OF A PRESERVATIVE. THE PATIENT HAD TMA STATUS POST KIDNEY TRANSPLANT FROM UNKNOWN ORIGIN. THE ORGANIZATION CONTINUES TO FURTHER INVESTIGATE AND IS REPORTING TO CREATE AWARENESS IF NEEDED.