Brand Name | CELL SAVER® ELITE® PLUS AUTOTRANSFUSION SYSTEM |
Type of Device | CS ELITE FASTPACK,125ML,150U |
Manufacturer (Section D) |
HAEMONETICS CORPORATION |
125 summer street |
boston MA 02110 |
|
Manufacturer (Section G) |
HAEMONETICS CORPORATION |
125 summer street |
|
boston MA 02110 |
|
Manufacturer Contact |
janice
kiser
|
125 summer street |
boston, MA 02110
|
|
MDR Report Key | 13001847 |
MDR Text Key | 290077218 |
Report Number | 1219343-2021-00153 |
Device Sequence Number | 1 |
Product Code |
CAC
|
UDI-Device Identifier | 10812747016537 |
UDI-Public | (01)10812747016537(17)240709(10)0721017 |
Combination Product (y/n) | N |
Reporter Country Code | AS |
PMA/PMN Number | K120586 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Foreign |
Reporter Occupation |
Non-Healthcare Professional
|
Type of Report
| Initial |
Report Date |
12/08/2021 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Model Number | CSE-FP-125V |
Device Lot Number | 0721017 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 12/08/2021 |
Initial Date Manufacturer Received |
12/08/2021
|
Initial Date FDA Received | 12/14/2021 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 07/10/2021 |
Is the Device Single Use? |
No
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Reuse
|
Patient Sequence Number | 1 |