Definition: If The Device Is Reusable, Validated Reprocessing Instructions And Reprocessing Validation Data For This Device Type Must Be Included In A 510(k) Submission (82 FR 26807, Available At Https://www.gpo.gov/fdsys/pkg/FR-2017-06-09/pdf/2017-12007.pdf).
| Device Type ID | 806 |
| Device Name | System, Thermal Regulating |
| Regulation Description | Thermal Regulating System. |
| Regulation Medical Specialty | Cardiovascular |
| Review Panel | Cardiovascular |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Cardiovascular Devices (DCD) Circulatory Support Devices Branch (CSDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 870.5900 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | DWJ |
| GMP Exempt | No |
| Summary MR | Ineligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Eligible For Accredited Persons Expansion Pilot Program |
| Device Type ID | 806 |
| Device | System, Thermal Regulating |
| Product Code | DWJ |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Thermal Regulating System. |
| CFR Regulation Number | 870.5900 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
3M COMPANY | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
BCG MEDICAL LLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
C. R. BARD, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
CARE ESSENTIALS PTY LTD | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
IOB MEDICAL INC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
MEDIVANCE, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
SMITHS | ||
SUBSTANTIALLY EQUIVALENT | 2 | |
SMITHS GROUP PLC | ||
SUBSTANTIALLY EQUIVALENT | 1 | |
STRYKER CORP. | ||
SUBSTANTIALLY EQUIVALENT | 3 | |
| Device Problems | |
|---|---|
Defective Component | 539 |
Device Sensing Problem | 196 |
Inaccurate Flow Rate | 89 |
Insufficient Cooling | 88 |
Insufficient Heating | 74 |
Adverse Event Without Identified Device Or Use Problem | 62 |
Restricted Flow Rate | 49 |
Improper Or Incorrect Procedure Or Method | 48 |
Circuit Failure | 45 |
Patient-Device Incompatibility | 34 |
Pumping Problem | 34 |
Insufficient Information | 32 |
Device Operates Differently Than Expected | 30 |
Temperature Problem | 29 |
Overheating Of Device | 26 |
Computer Operating System Problem | 25 |
Use Of Device Problem | 24 |
Insufficient Flow Or Under Infusion | 23 |
Pad | 20 |
Appropriate Term/Code Not Available | 16 |
Material Protrusion / Extrusion | 15 |
Air Leak | 15 |
Device Displays Incorrect Message | 14 |
Electrical /Electronic Property Problem | 10 |
Gas Leak | 10 |
Device Alarm System | 10 |
Break | 10 |
Leak / Splash | 9 |
Intermittent Continuity | 9 |
No Apparent Adverse Event | 8 |
Smoking | 8 |
Improper Flow Or Infusion | 8 |
Device Emits Odor | 7 |
Infusion Or Flow Problem | 7 |
Unknown (for Use When The Device Problem Is Not Known) | 6 |
Output Below Specifications | 5 |
Heater | 5 |
Fluid Leak | 4 |
Computer Software Problem | 4 |
Fitting Problem | 4 |
Device Dislodged Or Dislocated | 4 |
Device Reprocessing Problem | 4 |
Fire | 3 |
No Flow | 3 |
Therapeutic Or Diagnostic Output Failure | 3 |
No Display / Image | 3 |
Device Maintenance Issue | 3 |
Failure To Power Up | 3 |
Thermal Decomposition Of Device | 3 |
Output Problem | 3 |
Noise, Audible | 2 |
Torn Material | 2 |
Charred | 2 |
Calibration Problem | 2 |
Alarm | 2 |
Alarm, Audible | 2 |
Disconnection | 2 |
Material Separation | 2 |
Device Issue | 2 |
Accessory Incompatible | 2 |
Device Contamination With Chemical Or Other Material | 2 |
Excessive Heating | 2 |
No Audible Alarm | 2 |
Hose | 2 |
Melted | 2 |
Blower | 2 |
Electronic Property Issue | 2 |
Improper Device Output | 2 |
Compatibility Problem | 1 |
False Alarm | 1 |
Failure To Adhere Or Bond | 1 |
Corroded | 1 |
Low Readings | 1 |
Fracture | 1 |
Loss Of Or Failure To Bond | 1 |
Incorrect Measurement | 1 |
Deformation Due To Compressive Stress | 1 |
Difficult To Open Or Close | 1 |
Contamination / Decontamination Problem | 1 |
High Readings | 1 |
Device Misassembled During Manufacturing / Shipping | 1 |
Electrical Shorting | 1 |
Cover | 1 |
Sticking | 1 |
Component Or Accessory Incompatibility | 1 |
Hole In Material | 1 |
System | 1 |
Device Handling Problem | 1 |
Tube | 1 |
Kinked | 1 |
Loose Or Intermittent Connection | 1 |
Coupler | 1 |
Carbon Absorption | 1 |
Malposition Of Device | 1 |
Free Or Unrestricted Flow | 1 |
Electrical Overstress | 1 |
Cut In Material | 1 |
Crack | 1 |
Naturally Worn | 1 |
Missing Value Reason | 1 |
| Total Device Problems | 1751 |
| Recalls | |||
|---|---|---|---|
| Manufacturer | Recall Class | Date Posted | |
| 1 | 3M Company - Health Care Business | II | Feb-12-2018 |
| 2 | Bard Medical Division | II | Jul-24-2018 |
| 3 | C.R. Bard, Inc. | III | Feb-12-2018 |
| 4 | C.R. Bard, Inc. | II | Dec-20-2017 |
| 5 | C.R. Bard, Inc. | II | Aug-16-2017 |
| 6 | C.R. Bard, Inc. | III | Aug-05-2016 |
| 7 | C.R. Bard, Inc. | II | May-06-2016 |
| 8 | C.R. Bard, Inc. | II | Apr-14-2016 |
| 9 | C.R. Bard, Inc. | II | Feb-05-2016 |
| 10 | Cincinnati Sub-Zero Products Inc | II | Jun-10-2014 |
| 11 | Medtronic Perfusion Systems | II | Mar-06-2018 |
| 12 | Smiths Medical ASD, Inc. | II | May-22-2014 |
| 13 | Stryker Medical Division Of Stryker Corporation | II | Oct-24-2018 |
| 14 | Stryker Medical Division Of Stryker Corporation | II | Jan-27-2018 |
| 15 | Stryker Medical Division Of Stryker Corporation | II | May-10-2017 |
| 16 | Stryker Medical Division Of Stryker Corporation | II | Feb-05-2014 |