| Device Type ID | 2652 |
| Device Name | Warmer, Thermal, Infusion Fluid |
| Regulation Description | Infusion Pump. |
| Regulation Medical Specialty | General Hospital |
| Review Panel | General Hospital |
| Premarket Review | Center For Biologics Evaluation & Research (CBER) |
| Submission Type | 510(k) |
| CFR Regulation Number | 880.5725 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | LGZ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2652 |
| Device | Warmer, Thermal, Infusion Fluid |
| Product Code | LGZ |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Infusion Pump. |
| CFR Regulation Number | 880.5725 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
BELMONT INSTRUMENT CORPORATION | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
QUALITY IN FLOW LTD. | ||
SUBSTANTIALLY EQUIVALENT | 4 | |
RAND S.R.L. | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
| Device Problems | |
|---|---|
Fluid Leak | 22 |
Leak / Splash | 13 |
Excessive Heating | 11 |
Temperature Problem | 9 |
Infusion Or Flow Problem | 9 |
Device Displays Incorrect Message | 9 |
No Audible Alarm | 9 |
Adverse Event Without Identified Device Or Use Problem | 8 |
Device Alarm System | 8 |
Overheating Of Device | 7 |
Pressure Problem | 6 |
Electrical /Electronic Property Problem | 6 |
Appropriate Term/Code Not Available | 6 |
Alarm | 5 |
Tube | 4 |
Smoking | 4 |
Use Of Device Problem | 3 |
Circuit Failure | 3 |
Device Operates Differently Than Expected | 3 |
Device Emits Odor | 3 |
Device Contaminated During Manufacture Or Shipping | 3 |
Material Deformation | 3 |
Output Problem | 3 |
Insufficient Information | 2 |
Pressure Tubing | 2 |
Fracture | 2 |
Sparking | 2 |
Circuit Board | 2 |
No Display / Image | 2 |
Melted | 1 |
Signal Artifact | 1 |
Unknown (for Use When The Device Problem Is Not Known) | 1 |
Obstruction Of Flow | 1 |
No Apparent Adverse Event | 1 |
Reservoir | 1 |
Priming Problem | 1 |
Increase In Pressure | 1 |
Connection Problem | 1 |
False Alarm | 1 |
Contamination During Use | 1 |
Misconnection | 1 |
Product Quality Problem | 1 |
Improper Or Incorrect Procedure Or Method | 1 |
Battery Problem | 1 |
Electronic Property Issue | 1 |
Flare Or Flash | 1 |
Power Problem | 1 |
Fire | 1 |
Failure To Prime | 1 |
Failure To Sense | 1 |
Human-Device Interface Problem | 1 |
Filter | 1 |
Charred | 1 |
Noise, Audible | 1 |
Inaccurate Delivery | 1 |
No Fail-Safe Mechanism | 1 |
Defective Alarm | 1 |
Thermal Decomposition Of Device | 1 |
Component Falling | 1 |
Failure To Conduct | 1 |
Disconnection | 1 |
Material Rupture | 1 |
No Audible Prompt / Feedback | 1 |
Temperature Sensor | 1 |
Audible Prompt / Feedback | 1 |
Poor Quality Image | 1 |
Unintended Collision | 1 |
Device Contamination With Chemical Or Other Material | 1 |
Power Cord | 1 |
Plug | 1 |
Alarm Not Visible | 1 |
Detachment Of Device Component | 1 |
Loss Of Power | 1 |
Material Separation | 1 |
System | 1 |
Use Of Incorrect Control Settings | 1 |
Cassette | 1 |
| Total Device Problems | 217 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | Natus Manufacturing Limited | II | Jan-06-2017 |
| 2 | Smiths Medical ASD, Inc. | III | Feb-07-2017 |
| 3 | Smiths Medical ASD, Inc. | II | Apr-09-2014 |
| 4 | Steris Corporation | II | Jan-06-2016 |