| Device Type ID | 2674 |
| Device Name | Pump, Infusion, Elastomeric |
| 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 | MEB |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Program |
| Device Type ID | 2674 |
| Device | Pump, Infusion, Elastomeric |
| Product Code | MEB |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Infusion Pump. |
| CFR Regulation Number | 880.5725 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
HALYARD HEALTH | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
KIMBERLY-CLARK CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Fluid Leak | 1284 |
Filling Problem | 1173 |
Reservoir | 793 |
Material Rupture | 699 |
No Flow | 650 |
Inaccurate Flow Rate | 604 |
Infusion Or Flow Problem | 514 |
Port | 452 |
Device Contamination With Chemical Or Other Material | 285 |
Failure To Infuse | 252 |
Cap | 246 |
Excess Flow Or Over-Infusion | 206 |
Tube | 163 |
Leak / Splash | 162 |
Adverse Event Without Identified Device Or Use Problem | 129 |
Disconnection | 123 |
Break | 123 |
Device Operates Differently Than Expected | 86 |
Housing | 62 |
Connector | 60 |
Insufficient Flow Or Under Infusion | 43 |
Component Missing | 39 |
Loose Or Intermittent Connection | 37 |
Regulator | 33 |
Detachment Of Device Component | 26 |
Failure To Prime | 25 |
Failure To Deliver | 18 |
Filter | 18 |
Crack | 16 |
Reflux Within Device | 16 |
Material Deformation | 12 |
Material Separation | 11 |
Improper Or Incorrect Procedure Or Method | 10 |
Improper Flow Or Infusion | 9 |
Detachment Of Device Or Device Component | 7 |
Cut In Material | 7 |
Split | 7 |
Resistor | 7 |
Physical Resistance / Sticking | 7 |
Misconnection | 6 |
Material Puncture / Hole | 6 |
Catheter | 5 |
Material Integrity Problem | 5 |
Scratched Material | 5 |
Mechanical Problem | 4 |
Torn Material | 4 |
Device Contaminated During Manufacture Or Shipping | 4 |
Luer Valve | 4 |
Retraction Problem | 3 |
Device Difficult To Setup Or Prepare | 3 |
Bent | 3 |
Burst Container Or Vessel | 3 |
Partial Blockage | 3 |
Clamp | 3 |
Stretched | 3 |
Material Perforation | 2 |
Shelf Life Exceeded | 2 |
Adapter (Adaptor) | 2 |
Device Markings / Labelling Problem | 2 |
Manufacturing, Packaging Or Shipping Problem | 2 |
Volume Accuracy Problem | 2 |
Hole In Material | 2 |
Sticking | 2 |
Fitting Problem | 2 |
Fracture | 2 |
Device Operational Issue | 2 |
Defective Component | 2 |
Device Dislodged Or Dislocated | 2 |
Material Split, Cut Or Torn | 2 |
Connection Problem | 2 |
Backflow | 1 |
Circuit Failure | 1 |
Misassembled | 1 |
Device Displays Incorrect Message | 1 |
Appropriate Term/Code Not Available | 1 |
Difficult To Open Or Close | 1 |
Use Of Device Problem | 1 |
Loss Of Or Failure To Bond | 1 |
Melted | 1 |
Particulates | 1 |
Battery Problem | 1 |
Electro-Static Discharge | 1 |
Decoupling | 1 |
Battery | 1 |
Migration Or Expulsion Of Device | 1 |
Precipitate In Device Or Device Ingredient | 1 |
Complete Blockage | 1 |
Off-Label Use | 1 |
Mechanical Jam | 1 |
Pumping Problem | 1 |
Application Program Problem: Medication Error | 1 |
Post | 1 |
Device Alarm System | 1 |
Flaked | 1 |
Kinked | 1 |
Defective Device | 1 |
Packaging Problem | 1 |
| Total Device Problems | 8535 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Arrow International Inc | II | Feb-25-2019 |
| 2 | B. Braun Medical, Inc. | II | Sep-16-2014 |
| 3 | B. Braun Medical, Inc. | II | Feb-03-2014 |