Brand Name | Y ADAPTER |
Type of Device | APPARATUS, AUTOTRANSFUSION |
Manufacturer (Section D) |
PERFUSION SYSTEMS |
7611 northland dr |
brooklyn park MN 55428 |
|
Manufacturer (Section G) |
PERFUSION SYSTEMS |
7611 northland dr |
|
brooklyn park MN 55428 |
|
Manufacturer Contact |
paula
bixby
|
8200 coral sea street ne |
mounds view, MN 55112
|
7635055378
|
|
MDR Report Key | 8137347 |
MDR Text Key | 129614038 |
Report Number | 2184009-2018-00036 |
Device Sequence Number | 0 |
Product Code |
CAC
|
Reporter Country Code | US |
PMA/PMN Number | K812292 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,health |
Reporter Occupation |
Other Health Care Professional
|
Remedial Action |
Recall |
Type of Report
| Initial |
Report Date |
12/06/2018 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 06/30/2021 |
Device Model Number | BTC93 |
Device Catalogue Number | BTC93 |
Device Lot Number | 215737229 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 09/24/2018 |
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
11/15/2018
|
Initial Date FDA Received | 12/06/2018 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 06/30/2018 |
Is the Device Single Use? |
Yes
|
Type of Device Usage |
Initial
|
Removal/Correction Number | 2184009-11-30-2018-003-R |
Patient Sequence Number | 1 |