Brand Name | 3M RANGER¿ BLOOD/FLUID WARMING SYSTEM STANDARD FLOW |
Type of Device | STANDARD FLOW DISPOSABLE TUBING |
Manufacturer (Section D) |
3M HEALTH CARE |
2510 conway ave |
st. paul MN 55144 |
|
Manufacturer (Section G) |
NYPRO PRECISION ASSEMBLIES |
sor juana ines de la cruz |
cd. industrial |
tijuana, tijuana baja california 22444 |
MX
22444
|
|
Manufacturer Contact |
linda
johnsen
|
3m center, building 275-5w-06 |
2510 conway ave |
st. paul, MN 55144
|
6517374376
|
|
MDR Report Key | 7468621 |
MDR Text Key | 106742318 |
Report Number | 2110898-2018-00047 |
Device Sequence Number | 1 |
Product Code |
DWJ
|
Combination Product (y/n) | N |
Reporter Country Code | CA |
PMA/PMN Number | K973741 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,foreig |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
Report Date |
05/09/2018 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Model Number | N/A |
Device Catalogue Number | 24200 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Was the Report Sent to FDA? |
No
|
Initial Date Manufacturer Received |
03/29/2017 |
Initial Date FDA Received | 04/27/2018 |
Supplement Dates Manufacturer Received | 03/28/2018
|
Supplement Dates FDA Received | 05/09/2018
|
Was Device Evaluated by Manufacturer? |
No
|
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Initial
|
Patient Sequence Number | 1 |
Patient Outcome(s) |
Death;
|
|
|