SERVATOR H HTK SOLUTION
Received Mar 4, 2025 · Event occurred Dec 10, 2024
Report 3015942785-2025-70001 · MDR key 21516384
Device
Generic name
Organ Preservation Solution
Manufacturer
Global Transplant SolutionsProduct problems
- Adverse Event Without Identified Device or Use Problem
- No Apparent Adverse Event
- Insufficient Device Problem Information
- Adverse Event Without Identified Device or Use Problem
- No Apparent Adverse Event
- Insufficient Device Problem Information
Patient
NA · Unknown
- Kidney injury
- Kidney injury
Narrative
Additional Manufacturer Narrative
THE CUSTOMER WAS NOT ABLE TO PROVIDE THE PROBLEMATIC PRODUCT FOR REVIEW. IT WAS ALSO STATED THAT THE TEMPERATURE MONITORING WAS NOT AVAILABLE. BRIDGE TO LIFE QUALITY PERFORMED RECORD REVIEW AND FOUND NO HISTORY OF COMPLAINT OR ANY REPORTS INVOLVING EASISLUSH AS THE CAUSE OF FREEZING AN ORGAN. IN CONCLUSION, THERE WAS NO EVIDENCE TO SUPPORT THAT THE EASISLUSH CAUSED THE ORGAN TO FREEZE.
Description of Event or Problem
A KIDNEY WAS TAKEN OFF PUMP AND REPACKAGED TO BE SHIPPED ON ICE FROM CINCINNATI, OH TO MARYLAND VIA COMMERCIAL AIRLINER. IT WAS DENIED FOR TRANSPLANT UPON ARRIVAL BECAUSE THE HTK SOLUTION AND KIDNEY HAD BEGUN TO FREEZE. THE COURIER TOLD US THE KIDNEY WAS PLACED IN A PRESSURIZED CARGO BAY BUT THE AIRLINE TOLD US IT WOULD HAVE BEEN NEAR THE FRONT OF THE PLANE IN THE CABIN. THE KIDNEY WAS PACKAGED USING APPROXIMATELY 1L OF HTK (SERVATOR H). THAT BAG WAS PLACED IN A RIGID CONTAINER WITH EASISLUSH AND THEN PLACED IN ANOTHER BAG. THIS WAS PLACED ON WET ICE IN AN ORGAN SHIPPING BOX. OPTN GUIDELINES WERE FOLLOWED.