SET, ADMINISTRATION, INTRAVASCULAR
This device is manufactured by SMITHS MEDICAL ASD.
The following problems were reported about this device:
| Year | Description | Events/year | Type |
|---|---|---|---|
| 2024 | Pain | 1 | Patient |
| 2024 | Low Oxygen Saturation | 2 | Patient |
| 2024 | Insufficient Information | 11 | Patient |
| 2024 | Headache | 1 | Patient |
| 2024 | Volume Accuracy Problem | 1 | Device |
| 2024 | Pumping Problem | 1 | Device |
| 2024 | Product Quality Problem | 2 | Device |
| 2024 | No Flow | 1 | Device |
| 2024 | Low Audible Alarm | 1 | Device |
| 2024 | Key or Button Unresponsive/not Working | 1 | Device |
| 2024 | Intermittent Infusion | 1 | Device |
| 2024 | Insufficient Flow or Under Infusion | 2 | Device |
| 2024 | Infusion or Flow Problem | 1 | Device |
| 2024 | Inaccurate Delivery | 6 | Device |
| 2024 | Fracture | 2 | Device |
| 2024 | Fluid/Blood Leak | 1 | Device |
| 2024 | Display or Visual Feedback Problem | 2 | Device |
| 2024 | Display Difficult to Read | 1 | Device |
| 2024 | Device Sensing Problem | 2 | Device |
| 2024 | Device Alarm System | 18 | Device |
| 2024 | Defective Device | 1 | Device |
| 2024 | Break | 1 | Device |
| 2024 | Air/Gas in Device | 2 | Device |
| 2023 | Vomiting | 1 | Patient |
| 2023 | Syncope/Fainting | 1 | Patient |
| 2023 | Swelling/ Edema | 1 | Patient |
| 2023 | Pain | 1 | Patient |
| 2023 | Lethargy | 1 | Patient |
| 2023 | Insufficient Information | 73 | Patient |
| 2023 | Headache | 2 | Patient |
| 2023 | Fatigue | 2 | Patient |
| 2023 | Dyspnea | 2 | Patient |
| 2023 | Dizziness | 4 | Patient |
| 2023 | Arrhythmia | 1 | Patient |
| 2023 | Volume Accuracy Problem | 3 | Device |
| 2023 | Unexpected Shutdown | 1 | Device |
| 2023 | Solder Joint Fracture | 1 | Device |
| 2023 | Product Quality Problem | 76 | Device |
| 2023 | Pressure Problem | 5 | Device |
| 2023 | Premature Discharge of Battery | 2 | Device |
| 2023 | Power Problem | 3 | Device |
| 2023 | Poor Quality Image | 1 | Device |
| 2023 | Patient Device Interaction Problem | 1 | Device |
| 2023 | Partial Blockage | 7 | Device |
| 2023 | Overfill | 1 | Device |
| 2023 | Overcorrection | 1 | Device |
| 2023 | Obstruction of Flow | 8 | Device |
| 2023 | No Flow | 1 | Device |
| 2023 | No Audible Alarm | 3 | Device |
| 2023 | Moisture or Humidity Problem | 1 | Device |
| 2023 | Mechanical Problem | 4 | Device |
| 2023 | Material Split, Cut or Torn | 1 | Device |
| 2023 | Material Deformation | 1 | Device |
| 2023 | Loss of Power | 1 | Device |
| 2023 | Leak/Splash | 10 | Device |
| 2023 | Key or Button Unresponsive/not Working | 1 | Device |
| 2023 | Intermittent Loss of Power | 1 | Device |
| 2023 | Insufficient Information | 4 | Device |
| 2023 | Insufficient Flow or Under Infusion | 14 | Device |
| 2023 | Infusion or Flow Problem | 3 | Device |
| 2023 | Increase in Pressure | 1 | Device |
| 2023 | Inaccurate Flow Rate | 2 | Device |
| 2023 | Inaccurate Delivery | 83 | Device |
| 2023 | Improper Flow or Infusion | 6 | Device |
| 2023 | High Readings | 1 | Device |
| 2023 | Gas/Air Leak | 1 | Device |
| 2023 | Fracture | 1 | Device |
| 2023 | Fluid/Blood Leak | 15 | Device |
| 2023 | False Alarm | 1 | Device |
| 2023 | Failure to Power Up | 1 | Device |
| 2023 | Failure to Deliver | 12 | Device |
| 2023 | Failure to Calibrate | 1 | Device |
| 2023 | Excess Flow or Over-Infusion | 4 | Device |
| 2023 | Erratic or Intermittent Display | 1 | Device |
| 2023 | Display Difficult to Read | 2 | Device |
| 2023 | Device Sensing Problem | 3 | Device |
| 2023 | Device Dislodged or Dislocated | 1 | Device |
| 2023 | Device Alarm System | 189 | Device |
| 2023 | Defective Device | 2 | Device |
| 2023 | Crack | 1 | Device |
| 2023 | Contamination /Decontamination Problem | 2 | Device |
| 2023 | Connection Problem | 4 | Device |
| 2023 | Computer Operating System Problem | 1 | Device |
| 2023 | Component Missing | 1 | Device |
| 2023 | Complete Blockage | 1 | Device |
| 2023 | Calibration Problem | 6 | Device |
| 2023 | Burst Container or Vessel | 1 | Device |
| 2023 | Break | 3 | Device |
| 2023 | Battery Problem | 8 | Device |
| 2023 | Audible Prompt/Feedback Problem | 2 | Device |
| 2023 | Appropriate Term/Code Not Available | 1 | Device |
| 2023 | Air/Gas in Device | 18 | Device |
| 2022 | Insufficient Information | 8 | Patient |
| 2022 | Volume Accuracy Problem | 4 | Device |
| 2022 | Ventilation Problem in Device Environment | 1 | Device |
| 2022 | Separation Problem | 2 | Device |
| 2022 | Pumping Stopped | 1 | Device |
| 2022 | Pumping Problem | 2 | Device |
| 2022 | Protective Measures Problem | 2 | Device |
| 2022 | Product Quality Problem | 2 | Device |
| 2022 | Priming Problem | 2 | Device |
| 2022 | Partial Blockage | 2 | Device |
| 2022 | Optical Problem | 1 | Device |
| 2022 | Obstruction of Flow | 10 | Device |
| 2022 | No Flow | 4 | Device |
| 2022 | No Audible Alarm | 4 | Device |
| 2022 | Mechanical Problem | 2 | Device |
| 2022 | Material Integrity Problem | 1 | Device |
| 2022 | Low Audible Alarm | 1 | Device |
| 2022 | Loss of Data | 2 | Device |
| 2022 | Loose or Intermittent Connection | 1 | Device |
| 2022 | Leak/Splash | 9 | Device |
| 2022 | Insufficient Information | 7 | Device |
| 2022 | Insufficient Flow or Under Infusion | 34 | Device |
| 2022 | Infusion or Flow Problem | 5 | Device |
| 2022 | Increase in Pressure | 1 | Device |
| 2022 | Inaccurate Delivery | 15 | Device |
| 2022 | Improper Flow or Infusion | 5 | Device |
| 2022 | Fluid/Blood Leak | 27 | Device |
| 2022 | Fitting Problem | 1 | Device |
| 2022 | False Negative Result | 1 | Device |
| 2022 | False Alarm | 21 | Device |
| 2022 | Failure to Pump | 1 | Device |
| 2022 | Failure to Prime | 5 | Device |
| 2022 | Failure to Power Up | 7 | Device |
| 2022 | Failure to Infuse | 1 | Device |
| 2022 | Failure to Deliver | 4 | Device |
| 2022 | Failure to Calibrate | 1 | Device |
| 2022 | Excess Flow or Over-Infusion | 5 | Device |
| 2022 | Electrical /Electronic Property Problem | 1 | Device |
| 2022 | Display or Visual Feedback Problem | 1 | Device |
| 2022 | Disconnection | 1 | Device |
| 2022 | Difficult to Insert | 1 | Device |
| 2022 | Device Sensing Problem | 1 | Device |
| 2022 | Device Markings/Labelling Problem | 1 | Device |
| 2022 | Device Fell | 1 | Device |
| 2022 | Device Alarm System | 350 | Device |
| 2022 | Detachment of Device or Device Component | 1 | Device |
| 2022 | Defective Device | 1 | Device |
| 2022 | Defective Component | 5 | Device |
| 2022 | Defective Alarm | 2 | Device |
| 2022 | Date/Time-Related Software Problem | 1 | Device |
| 2022 | Crack | 1 | Device |
| 2022 | Contamination | 1 | Device |
| 2022 | Connection Problem | 61 | Device |
| 2022 | Computer Software Problem | 1 | Device |
| 2022 | Computer Operating System Problem | 1 | Device |
| 2022 | Component Missing | 1 | Device |
| 2022 | Circuit Failure | 1 | Device |
| 2022 | Calibration Problem | 6 | Device |
| 2022 | Break | 2 | Device |
| 2022 | Battery Problem | 3 | Device |
| 2022 | Audible Prompt/Feedback Problem | 31 | Device |
| 2022 | Application Program Problem | 1 | Device |
| 2022 | Air/Gas in Device | 31 | Device |
| 2021 | Leak/Splash | 1 | Device |
| 2021 | Infusion or Flow Problem | 4 | Device |
| 2021 | False Alarm | 4 | Device |
| 2021 | Device Displays Incorrect Message | 3 | Device |
| 2021 | Device Alarm System | 16 | Device |
| 2021 | Defective Alarm | 2 | Device |
| 2021 | Connection Problem | 1 | Device |
| 2021 | Audible Prompt/Feedback Problem | 2 | Device |
| 2021 | Air/Gas in Device | 2 | Device |
| 2020 | Leak/Splash | 1 | Device |
| 2020 | Infusion or Flow Problem | 3 | Device |
| 2020 | Incomplete or Inadequate Priming | 1 | Device |
| 2020 | Fluid/Blood Leak | 3 | Device |
| 2020 | False Alarm | 1 | Device |
| 2020 | Excess Flow or Over-Infusion | 1 | Device |
| 2020 | Device Alarm System | 1 | Device |
| 2020 | Contamination /Decontamination Problem | 1 | Device |
| 2020 | Air/Gas in Device | 2 | Device |