Device product
2008T, Hemodialysis Delivery System Product Indicated for acute and chronic dialysis therapy.
Z-0829-2018
Product summary
- Event
- Event 79239
- Status
- Terminated
- Classification
- Class II
- Quantity
- 15 machines
- Official record key
device-enforcement:Z-0829-2018
Official wording
Reason: While reviewing documentation for the next software release of the 2008T, an R&D technician identified that setting the UF goal to '0' introduces a discrepancy between the UF rate displayed and the actual UF pump rate. The software anomaly is also applicable to the 2008T Machines that contained the 2.63 Bug Fix per DCAF 17-088. 2008T Upgrade kits that contained the 2.63 Bug Fix are also affected. Additionally, SW version 2.64 (in design freeze) is also impacted by this anomaly.
Code information: 2008T machines: 190766 2008T Hemodialysis System w/Bibag 190895 2008T GEN 2 Bibag without CDX 190766 = 00840861100910 (+Serial Number) 190895 = 00840861100927 (+Serial Number)ux=&Su
Distribution pattern: US Nationwide Distribution
Derived failure modes
-
Device software or design
software anomaly