| Device Type ID | 2688 |
| Device Name | Accessories, Pump, Infusion |
| Regulation Description | Infusion Pump. |
| 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) |
| CFR Regulation Number | 880.5725 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | MRZ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
| Device Type ID | 2688 |
| Device | Accessories, Pump, Infusion |
| Product Code | MRZ |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Infusion Pump. |
| CFR Regulation Number | 880.5725 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
B. BRAUN MEDICAL INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
B. BRAUN MEDICAL, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
HOSPIRA, INC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
HOSPIRA, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ICU MEDICAL | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
ICU MEDICAL SALES, INC. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
IVWATCH, LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
WELLDOC, INC | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
| Device Problems | |
|---|---|
Break | 131 |
Power Cord | 81 |
Power Problem | 14 |
Adverse Event Without Identified Device Or Use Problem | 14 |
Adapter (Adaptor) | 13 |
Thermal Decomposition Of Device | 12 |
Excess Flow Or Over-Infusion | 9 |
Temperature Problem | 8 |
Device Issue | 6 |
Electrical /Electronic Property Problem | 6 |
Smoking | 5 |
Failure To Power Up | 5 |
Device Alarm System | 5 |
Melted | 4 |
Sparking | 3 |
Mechanical Problem | 3 |
Difficult To Position | 2 |
Plug | 2 |
Battery | 2 |
Battery Problem | 2 |
Charging Problem | 2 |
Appropriate Term/Code Not Available | 2 |
Cord | 2 |
Failure To Charge | 2 |
Use Of Device Problem | 1 |
Difficult Or Delayed Positioning | 1 |
Flare Or Flash | 1 |
Corroded | 1 |
Battery Charger | 1 |
Failure To Prime | 1 |
Failure To Infuse | 1 |
Arcing | 1 |
Electrical Shorting | 1 |
Device Damaged By Another Device | 1 |
Pump | 1 |
Charred | 1 |
| Total Device Problems | 347 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | ICU Medical Inc | II | Dec-17-2018 |