PUMP, INFUSION, PCA
This device is manufactured by RESPIRONICS, SMITHS MEDICAL ASD, ST JUDE MEDICAL.
The following problems were reported about this device:
| Year | Description | Events/year | Type |
|---|---|---|---|
| 2024 | Unspecified Respiratory Problem | 1 | Patient |
| 2024 | Low Blood Pressure/ Hypotension | 1 | Patient |
| 2024 | Insufficient Information | 158 | Patient |
| 2024 | Fever | 1 | Patient |
| 2024 | Volume Accuracy Problem | 25 | Device |
| 2024 | Pumping Problem | 1 | Device |
| 2024 | Priming Problem | 1 | Device |
| 2024 | Pressure Problem | 3 | Device |
| 2024 | Power Problem | 1 | Device |
| 2024 | Physical Resistance/Sticking | 1 | Device |
| 2024 | Partial Blockage | 3 | Device |
| 2024 | Obstruction of Flow | 3 | Device |
| 2024 | No Audible Alarm | 1 | Device |
| 2024 | Misconnection | 2 | Device |
| 2024 | Mechanical Problem | 9 | Device |
| 2024 | Material Twisted/Bent | 1 | Device |
| 2024 | Material Integrity Problem | 25 | Device |
| 2024 | Material Deformation | 7 | Device |
| 2024 | Loss of Data | 1 | Device |
| 2024 | Loose or Intermittent Connection | 1 | Device |
| 2024 | Key or Button Unresponsive/not Working | 1 | Device |
| 2024 | Intermittent Infusion | 1 | Device |
| 2024 | Insufficient Information | 21 | Device |
| 2024 | Insufficient Flow or Under Infusion | 9 | Device |
| 2024 | Infusion or Flow Problem | 3 | Device |
| 2024 | Inaccurate Flow Rate | 7 | Device |
| 2024 | Inaccurate Delivery | 23 | Device |
| 2024 | Improper Flow or Infusion | 5 | Device |
| 2024 | False Alarm | 4 | Device |
| 2024 | Failure to Sense | 11 | Device |
| 2024 | Failure to Power Up | 1 | Device |
| 2024 | Failure to Infuse | 6 | Device |
| 2024 | Failure to Deliver | 1 | Device |
| 2024 | Failure to Calibrate | 1 | Device |
| 2024 | Failure of Device to Self-Test | 2 | Device |
| 2024 | Excess Flow or Over-Infusion | 17 | Device |
| 2024 | Electrical /Electronic Property Problem | 6 | Device |
| 2024 | Display or Visual Feedback Problem | 1 | Device |
| 2024 | Device Sensing Problem | 8 | Device |
| 2024 | Device Difficult to Maintain | 1 | Device |
| 2024 | Device Alarm System | 120 | Device |
| 2024 | Degraded | 2 | Device |
| 2024 | Defective Device | 10 | Device |
| 2024 | Defective Component | 8 | Device |
| 2024 | Defective Alarm | 3 | Device |
| 2024 | Decrease in Pressure | 2 | Device |
| 2024 | Crack | 2 | Device |
| 2024 | Connection Problem | 1 | Device |
| 2024 | Computer Software Problem | 1 | Device |
| 2024 | Component Missing | 1 | Device |
| 2024 | Complete Blockage | 1 | Device |
| 2024 | Circuit Failure | 2 | Device |
| 2024 | Break | 3 | Device |
| 2024 | Blocked Connection | 1 | Device |
| 2024 | Battery Problem | 2 | Device |
| 2024 | Application Program Problem | 2 | Device |
| 2024 | Application Network Problem | 1 | Device |
| 2024 | Air/Gas in Device | 10 | Device |
| 2023 | Pain | 1 | Patient |
| 2023 | Insufficient Information | 104 | Patient |
| 2023 | Burn(s) | 2 | Patient |
| 2023 | Wireless Communication Problem | 1 | Device |
| 2023 | Volume Accuracy Problem | 18 | Device |
| 2023 | Use of Device Problem | 1 | Device |
| 2023 | Unexpected Shutdown | 1 | Device |
| 2023 | Pumping Stopped | 1 | Device |
| 2023 | Product Quality Problem | 1 | Device |
| 2023 | Power Problem | 2 | Device |
| 2023 | Obstruction of Flow | 2 | Device |
| 2023 | No Flow | 2 | Device |
| 2023 | Mechanical Problem | 2 | Device |
| 2023 | Material Integrity Problem | 2 | Device |
| 2023 | Loss of Data | 1 | Device |
| 2023 | Key or Button Unresponsive/not Working | 1 | Device |
| 2023 | Intermittent Loss of Power | 1 | Device |
| 2023 | Intermittent Continuity | 2 | Device |
| 2023 | Insufficient Information | 1 | Device |
| 2023 | Insufficient Flow or Under Infusion | 4 | Device |
| 2023 | Infusion or Flow Problem | 8 | Device |
| 2023 | Increased Pump Speed | 1 | Device |
| 2023 | Inaccurate Delivery | 11 | Device |
| 2023 | Failure to Sense | 3 | Device |
| 2023 | Failure to Infuse | 1 | Device |
| 2023 | Failure to Deliver | 1 | Device |
| 2023 | Failure to Charge | 2 | Device |
| 2023 | Failure to Calibrate | 2 | Device |
| 2023 | Excess Flow or Over-Infusion | 11 | Device |
| 2023 | Device Difficult to Maintain | 1 | Device |
| 2023 | Device Alarm System | 54 | Device |
| 2023 | Defective Component | 1 | Device |
| 2023 | Defective Alarm | 1 | Device |
| 2023 | Connection Problem | 2 | Device |
| 2023 | Calibration Problem | 2 | Device |
| 2023 | Battery Problem | 2 | Device |
| 2023 | Application Program Problem: Parameter Calculation Error | 1 | Device |
| 2023 | Air/Gas in Device | 1 | Device |
| 2023 | Adverse Event Without Identified Device or Use Problem | 3 | Device |
| 2022 | Volume Accuracy Problem | 8 | Device |
| 2022 | Output Problem | 1 | Device |
| 2022 | Material Integrity Problem | 2 | Device |
| 2022 | Infusion or Flow Problem | 2 | Device |
| 2022 | Incorrect Measurement | 5 | Device |
| 2022 | Inaccurate Delivery | 9 | Device |
| 2022 | Improper Flow or Infusion | 1 | Device |
| 2022 | Fracture | 1 | Device |
| 2022 | Excess Flow or Over-Infusion | 1 | Device |
| 2022 | Device Alarm System | 3 | Device |
| 2022 | Detachment of Device or Device Component | 1 | Device |
| 2022 | Computer Software Problem | 2 | Device |
| 2022 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
| 2020 | Volume Accuracy Problem | 6 | Device |
| 2020 | Sparking | 1 | Device |
| 2020 | Insufficient Flow or Under Infusion | 6 | Device |
| 2020 | Infusion or Flow Problem | 3 | Device |
| 2020 | Inaccurate Delivery | 2 | Device |
| 2020 | Excess Flow or Over-Infusion | 6 | Device |
| 2020 | Environmental Particulates | 1 | Device |
| 2020 | Electrical /Electronic Property Problem | 1 | Device |
| 2019 | Volume Accuracy Problem | 30 | Device |
| 2019 | Use of Device Problem | 3 | Device |
| 2019 | Unstable | 1 | Device |
| 2019 | Temperature Problem | 1 | Device |
| 2019 | Pumping Stopped | 1 | Device |
| 2019 | Pressure Problem | 1 | Device |
| 2019 | Patient Device Interaction Problem | 1 | Device |
| 2019 | Mechanical Problem | 1 | Device |
| 2019 | Material Invagination | 1 | Device |
| 2019 | Insufficient Flow or Under Infusion | 27 | Device |
| 2019 | Infusion or Flow Problem | 34 | Device |
| 2019 | Inaccurate Flow Rate | 1 | Device |
| 2019 | Inaccurate Delivery | 32 | Device |
| 2019 | Improper Flow or Infusion | 1 | Device |
| 2019 | High impedance | 1 | Device |
| 2019 | Failure to Pump | 1 | Device |
| 2019 | Failure to Infuse | 1 | Device |
| 2019 | Failure to Calibrate | 1 | Device |
| 2019 | Excess Flow or Over-Infusion | 42 | Device |
| 2019 | Electrical Power Problem | 1 | Device |
| 2019 | Device Sensing Problem | 1 | Device |
| 2019 | Device Displays Incorrect Message | 1 | Device |
| 2019 | Device Alarm System | 2 | Device |
| 2019 | Calibration Problem | 3 | Device |
| 2019 | Break | 3 | Device |
| 2019 | Appropriate Term/Code Not Available | 1 | Device |
| 2019 | Adverse Event Without Identified Device or Use Problem | 1 | Device |
| 2018 | Insufficient Information | 1 | Patient |
| 2018 | Volume Accuracy Problem | 1 | Device |
| 2018 | Unsealed Device Packaging | 1 | Device |
| 2018 | Torn Material | 1 | Device |
| 2018 | Therapeutic or Diagnostic Output Failure | 1 | Device |
| 2018 | Temperature Problem | 1 | Device |
| 2018 | Smoking | 1 | Device |
| 2018 | Pumping Stopped | 3 | Device |
| 2018 | Overheating of Device | 1 | Device |
| 2018 | Output Problem | 4 | Device |
| 2018 | Obstruction of Flow | 1 | Device |
| 2018 | Material Protrusion/Extrusion | 1 | Device |
| 2018 | Insufficient Information | 1 | Device |
| 2018 | Insufficient Flow or Under Infusion | 7 | Device |
| 2018 | Infusion or Flow Problem | 12 | Device |
| 2018 | Inaccurate Flow Rate | 1 | Device |
| 2018 | Inaccurate Dispensing | 1 | Device |
| 2018 | Inaccurate Delivery | 10 | Device |
| 2018 | Improper Flow or Infusion | 2 | Device |
| 2018 | False Alarm | 2 | Device |
| 2018 | Failure to Infuse | 2 | Device |
| 2018 | Excess Flow or Over-Infusion | 20 | Device |
| 2018 | Electrical Shorting | 1 | Device |
| 2018 | Device Operates Differently Than Expected | 1 | Device |
| 2018 | Device Handling Problem | 1 | Device |
| 2018 | Device Displays Incorrect Message | 7 | Device |
| 2018 | Device Alarm System | 4 | Device |
| 2018 | Delivery System Failure | 1 | Device |
| 2018 | Battery Problem | 1 | Device |
| 2017 | Use of Device Problem | 1 | Device |
| 2017 | Thermal Decomposition of Device | 2 | Device |
| 2017 | Structural Problem | 1 | Device |
| 2017 | Smoking | 2 | Device |
| 2017 | No Apparent Adverse Event | 1 | Device |
| 2017 | Melted | 1 | Device |
| 2017 | Insufficient Information | 1 | Device |
| 2017 | Inaccurate Dispensing | 1 | Device |
| 2017 | Inaccurate Delivery | 2 | Device |
| 2017 | Improper Flow or Infusion | 1 | Device |
| 2017 | Fracture | 1 | Device |
| 2017 | Failure to Power Up | 6 | Device |
| 2017 | Excess Flow or Over-Infusion | 1 | Device |
| 2017 | Electrical Shorting | 7 | Device |
| 2017 | Device Operates Differently Than Expected | 1 | Device |
| 2017 | Device Displays Incorrect Message | 1 | Device |
| 2017 | Device Alarm System | 1 | Device |
| 2017 | Defective Component | 1 | Device |
| 2017 | Charred | 1 | Device |
| 2017 | Charging Problem | 1 | Device |
| 2017 | Adverse Event Without Identified Device or Use Problem | 3 | Device |
| 2016 | Programming Issue | 1 | Device |
| 2016 | No Apparent Adverse Event | 2 | Device |
| 2016 | Insufficient Flow or Under Infusion | 9 | Device |
| 2016 | False Alarm | 1 | Device |
| 2016 | Failure to Deliver | 1 | Device |
| 2016 | Device Alarm System | 1 | Device |
| 2016 | Adverse Event Without Identified Device or Use Problem | 2 | Device |
| 2014 | Loose or Intermittent Connection | 1 | Device |
| 2014 | Adverse Event Without Identified Device or Use Problem | 1 | Device |