Brand Name | ORTHOPAT PERIOPERATIVE AUTOTRANSFUSION SYSTEM |
Type of Device | APPARATUS, AUTOTRANSFUSION |
Manufacturer (Section D) |
HAEMONETICS CORP |
400 wood rd |
braintree MA 02184 |
|
Manufacturer (Section G) |
HAEMONETICS CORP |
400 wood rd |
|
braintree MA 02184 |
|
Manufacturer Contact |
julie
smith, rn
|
400 wood rd |
braintree, MA 02184
|
7819170643
|
|
MDR Report Key | 5323849 |
MDR Text Key | 35009850 |
Report Number | 1219343-2015-00022 |
Device Sequence Number | 1 |
Product Code |
CAC
|
Combination Product (y/n) | N |
Reporter Country Code | JA |
PMA/PMN Number | K992723 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
foreign |
Reporter Occupation |
Other
|
Remedial Action |
Recall |
Type of Report
| Initial |
Report Date |
11/30/2015 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 12/23/2015 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | 1050-110-JPN |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 12/01/2015 |
Is the Reporter a Health Professional? |
No
|
Date Manufacturer Received | 11/30/2015 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 11/07/2011 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Reuse
|
Removal/Correction Number | 1219343-04/29/2011-001-R |
Patient Sequence Number | 1 |