| Device Type ID | 2692 |
| Device Name | System/device, Pharmacy Compounding |
| Regulation Description | Intravascular Administration Set. |
| Regulation Medical Specialty | General Hospital |
| Review Panel | General Hospital |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Anesthesiology, General Hospital, Infection Control, And Dental Devices (DAGRID) General Hospital Devices Branch (GHDB) |
| Submission Type | 510(K) Exempt |
| CFR Regulation Number | 880.5440 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | NEP |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
|
| Device Type ID | 2692 |
| Device | System/device, Pharmacy Compounding |
| Product Code | NEP |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Intravascular Administration Set. |
| CFR Regulation Number | 880.5440 [🔎] |
| Device Problems | |
|---|---|
Break | 23 |
Use Of Device Problem | 16 |
Failure To Align | 13 |
Connector | 12 |
Improper Or Incorrect Procedure Or Method | 9 |
Cable | 8 |
Device Operates Differently Than Expected | 7 |
Improper Flow Or Infusion | 7 |
Disconnection | 6 |
Material Separation | 6 |
Tube | 4 |
Power Cord | 4 |
Housing | 4 |
Thermal Decomposition Of Device | 4 |
Infusion Or Flow Problem | 4 |
Port | 4 |
Material Integrity Problem | 4 |
Bags | 3 |
Device Displays Incorrect Message | 3 |
Degraded | 2 |
Improper Device Output | 2 |
Product Quality Problem | 2 |
Device Markings / Labelling Problem | 2 |
Fluid Leak | 2 |
Incorrect, Inadequate Or Imprecise Result Or Readings | 2 |
Crack | 2 |
Adapter (Adaptor) | 2 |
Device Contamination With Chemical Or Other Material | 2 |
Fail-Safe Design Failure | 1 |
Leak / Splash | 1 |
Inadequate Or Insufficient Training | 1 |
Application Program Problem: Medication Error | 1 |
Filter | 1 |
Filling Problem | 1 |
Cut In Material | 1 |
Defective Device | 1 |
Loose Or Intermittent Connection | 1 |
Volume Accuracy Problem | 1 |
Computer Software Problem | 1 |
Defective Component | 1 |
Device Operational Issue | 1 |
Melted | 1 |
Adverse Event Without Identified Device Or Use Problem | 1 |
Electrical /Electronic Property Problem | 1 |
Misassembled | 1 |
| Total Device Problems | 176 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | B. Braun Medical, Inc. | II | Jul-03-2018 |
| 2 | Baxter Corporation Englewood | II | May-18-2015 |
| 3 | Baxter Corporation Englewood | II | Jun-22-2014 |
| 4 | Baxter Corporation Englewood | I | May-12-2014 |
| 5 | Baxter Healthcare Corp. | II | Jan-07-2016 |
| 6 | HEALTH ROBOTICS S.R.L. | II | Jan-10-2017 |
| 7 | ICU Medical, Inc. | II | Apr-11-2016 |
| 8 | The Metrix Company | II | Jul-22-2016 |