SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
This device is manufactured by BAXTER HEALTHCARE - MOUNTAIN HOME.
The following problems were reported about this device:
| Year | Description | Events/year | Type |
|---|---|---|---|
| 2023 | Insufficient Information | 2 | Patient |
| 2023 | Insufficient Information | 1 | Device |
| 2023 | Fluid/Blood Leak | 1 | Device |
| 2019 | Protective Measures Problem | 1 | Device |
| 2019 | Misassembled | 1 | Device |
| 2019 | Material Split, Cut or Torn | 2 | Device |
| 2019 | Material Puncture/Hole | 4 | Device |
| 2019 | Incomplete or Inadequate Connection | 1 | Device |
| 2019 | Improper or Incorrect Procedure or Method | 1 | Device |
| 2019 | Fluid/Blood Leak | 7 | Device |
| 2019 | Disconnection | 1 | Device |
| 2019 | Connection Problem | 2 | Device |
| 2018 | Material Perforation | 1 | Device |
| 2018 | Loose or Intermittent Connection | 1 | Device |
| 2018 | Improper or Incorrect Procedure or Method | 1 | Device |
| 2018 | Improper Flow or Infusion | 1 | Device |
| 2018 | Hole In Material | 2 | Device |
| 2018 | Fluid/Blood Leak | 9 | Device |
| 2018 | Disconnection | 1 | Device |
| 2018 | Device Operates Differently Than Expected | 1 | Device |
| 2018 | Cut In Material | 2 | Device |
| 2017 | Loose or Intermittent Connection | 2 | Device |
| 2017 | Improper or Incorrect Procedure or Method | 2 | Device |
| 2017 | Hole In Material | 5 | Device |
| 2017 | Fluid/Blood Leak | 16 | Device |
| 2017 | Device Operates Differently Than Expected | 3 | Device |
| 2017 | Device Displays Incorrect Message | 1 | Device |
| 2017 | Device Contamination with Chemical or Other Material | 1 | Device |
| 2017 | Cut In Material | 4 | Device |
| 2017 | Crack | 1 | Device |
| 2017 | Component Missing | 12 | Device |
| 2017 | Break | 2 | Device |
| 2017 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
| 2016 | Loose or Intermittent Connection | 2 | Device |
| 2016 | Hole In Material | 2 | Device |
| 2016 | Fluid/Blood Leak | 3 | Device |
| 2016 | Device Displays Incorrect Message | 2 | Device |
| 2016 | Component Missing | 1 | Device |
| 2015 | Hole In Material | 1 | Device |
| 2015 | Fluid/Blood Leak | 1 | Device |
| 2014 | Positioning Problem | 1 | Device |
| 2014 | Melted | 1 | Device |
| 2014 | Leak/Splash | 7 | Device |
| 2014 | Insufficient Information | 49 | Device |
| 2014 | Improper or Incorrect Procedure or Method | 4 | Device |
| 2014 | Hole In Material | 5 | Device |
| 2014 | Fluid/Blood Leak | 3 | Device |
| 2014 | Fitting Problem | 1 | Device |
| 2014 | Disconnection | 1 | Device |
| 2014 | Device Operates Differently Than Expected | 1 | Device |
| 2014 | Device Displays Incorrect Message | 3 | Device |
| 2014 | Crack | 1 | Device |
| 2014 | Contamination | 6 | Device |
| 2014 | Component Missing | 3 | Device |
| 2014 | Break | 4 | Device |
| 2014 | Air Leak | 2 | Device |
| 2014 | Adverse Event Without Identified Device or Use Problem | 40 | Device |
| 2013 | Leak/Splash | 1 | Device |
| 2013 | Insufficient Information | 12 | Device |
| 2013 | Hole In Material | 1 | Device |
| 2013 | Contamination | 1 | Device |
| 2013 | Adverse Event Without Identified Device or Use Problem | 10 | Device |