Device product
RTL190828: 2008K@HOME HEMODIALYSIS SYSTEM - Blood Pump Rotor spare part, Model Number: F40015481 Rev A
Z-2345-2024
Product summary
- Event
- Event 94775
- Status
- Ongoing
- Classification
- Class II
- Quantity
- 1 unit
- Official record key
device-enforcement:Z-2345-2024
Official wording
Reason: An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting loose/dislodged guide sheaves.
Code information: Model Number: RTL190828 (Rental Units); UDI/DI: 00840861100941; Serial Number: 1K0S172181
Distribution pattern: Domestic: Nationwide Distribution. International: Canada.
Derived failure modes
-
Unknown
An increased number of complaints were reported on the Blood Pump Rotor (P/N - F40015481 REV A) after a period of use by clinics noting loose/dislodged guide sheaves.