SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
This device is manufactured by FRESENIUS MEDICAL CARE NORTH AMERICA, FRESENIUS MEDICAL CARE REYNOSA MANUFACTURING.
The following problems were reported about this device:
| Year | Description | Events/year | Type |
|---|---|---|---|
| 2024 | Vomiting | 2 | Patient |
| 2024 | Unspecified Infection | 2 | Patient |
| 2024 | Sepsis | 2 | Patient |
| 2024 | Peritonitis | 114 | Patient |
| 2024 | Pain | 2 | Patient |
| 2024 | Nausea | 2 | Patient |
| 2024 | Low Blood Pressure/ Hypotension | 2 | Patient |
| 2024 | Loss of consciousness | 2 | Patient |
| 2024 | Insufficient Information | 2 | Patient |
| 2024 | Hypoxia | 2 | Patient |
| 2024 | Hypervolemia | 2 | Patient |
| 2024 | Fungal Infection | 6 | Patient |
| 2024 | Fever | 4 | Patient |
| 2024 | Fall | 2 | Patient |
| 2024 | Dyspnea | 4 | Patient |
| 2024 | Diarrhea | 4 | Patient |
| 2024 | Cramp(s) /Muscle Spasm(s) | 4 | Patient |
| 2024 | Abdominal Pain | 80 | Patient |
| 2024 | Abdominal Distention | 2 | Patient |
| 2024 | Fluid/Blood Leak | 79 | Device |
| 2024 | Disconnection | 2 | Device |
| 2024 | Adverse Event Without Identified Device or Use Problem | 90 | Device |
| 2023 | Vomiting | 2 | Patient |
| 2023 | Unspecified Infection | 3 | Patient |
| 2023 | Sepsis | 2 | Patient |
| 2023 | Peritonitis | 94 | Patient |
| 2023 | Peritoneal Laceration(s) | 1 | Patient |
| 2023 | Malaise | 2 | Patient |
| 2023 | Lethargy | 2 | Patient |
| 2023 | Fever | 4 | Patient |
| 2023 | Fatigue | 1 | Patient |
| 2023 | Constipation | 2 | Patient |
| 2023 | Confusion/ Disorientation | 1 | Patient |
| 2023 | Abdominal Pain | 57 | Patient |
| 2023 | Fluid/Blood Leak | 115 | Device |
| 2023 | Disconnection | 2 | Device |
| 2023 | Detachment of Device or Device Component | 1 | Device |
| 2023 | Adverse Event Without Identified Device or Use Problem | 90 | Device |
| 2022 | Peritonitis | 8 | Patient |
| 2022 | Fungal Infection | 2 | Patient |
| 2022 | Abdominal Pain | 6 | Patient |
| 2022 | Material Puncture/Hole | 1 | Device |
| 2022 | Fluid/Blood Leak | 153 | Device |
| 2022 | Disconnection | 1 | Device |
| 2022 | Adverse Event Without Identified Device or Use Problem | 81 | Device |
| 2021 | Adverse Event Without Identified Device or Use Problem | 10 | Device |