| Device |
system, dialysate delivery, sealed |
| Regulation Description |
High permeability hemodialysis system. |
| Product Code | FII |
| Regulation Number |
876.5860
|
|---|
| Device Class |
2
|
| Device Problems |
| Normal |
67 |
| Disconnection |
21 |
| Fluid leak |
14 |
| Calibration error |
12 |
| Defective component |
10 |
| Fluid/volume, increased |
8 |
| Conductivity |
6 |
| Device alarm system issue |
5 |
| Malfunction |
4 |
| Component(s), worn |
4 |
| Failure, intermittent |
4 |
| Pre or post-pumping problem |
4 |
| Alarm, failure of low flow |
4 |
| Dislodged |
3 |
| Inaccurate flowrate |
3 |
| Leak |
3 |
| Improper or incorrect procedure or method |
3 |
| Parameter calculation error due to software problem |
2 |
| Device inoperable |
2 |
| Incorrect measurement |
2 |
| Failure to pump |
2 |
| Other (for use when an appropriate device code cannot be identified) |
2 |
| Unknown (for use when the device problem is not known) |
2 |
| Method, improper/incorrect |
2 |
| Sensor problems |
2 |
| Electrical wires, defective |
2 |
| Bubble detector, failure of |
2 |
| Loose or intermittent connection |
2 |
| Dose calculation error due to software problem |
2 |
| Computer software issue |
1 |
| Percutaneous |
1 |
| Increase in pressure |
1 |
| Device Rinsing Issue |
1 |
| Residue after decontamination |
1 |
| Device displays error message |
1 |
| Locking mechanism failure |
1 |
| Device Issue |
1 |
| Alarm, audible |
1 |
| Alarm, failure of warning |
1 |
| Computer failure |
1 |
| False reading from device non-compliance |
1 |
| Accuracy rate |
1 |
| Inaccurate delivery |
1 |
| Improper flow or infusion |
1 |
| Not audible alarm |
1 |
| Occlusion, incorrect |
1 |
| Pressure issue |
1 |
| Total Device Problems |
217 |
|
| Recalls |
| |
2007 |
2008 |
2009 |
2010 |
2011 |
2012 |
2013 |
| Class I |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
| Class II |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
| Class III |
0 |
0 |
0 |
0 |
0 |
0 |
0 |
|
|
|
