Brand Name | CELL SAVER ELITE AUTOTRANSFUSION SYSTEM |
Type of Device | CELL SAVER ELITE SET - 125ML, |
Manufacturer (Section D) |
HAEMONETICS COPORATION |
125 summer street |
boston, ma |
|
Manufacturer (Section G) |
HAEMONETICS CORPORATION |
125 summer street |
|
boston, ma |
|
Manufacturer Contact |
miranda
holland
|
125 summer street |
boston, ma
|
8487100
|
|
MDR Report Key | 10421301 |
MDR Text Key | 204409411 |
Report Number | 1219343-2020-00074 |
Device Sequence Number | 1 |
Product Code |
CAC
|
Combination Product (y/n) | N |
Reporter Country Code | JA |
PMA/PMN Number | K120586 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
foreign |
Reporter Occupation |
Biomedical Engineer
|
Type of Report
| Initial |
Report Date |
07/22/2020 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 08/18/2020 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 01/13/2023 |
Device Model Number | CSE-P-125-JA |
Device Lot Number | 0120047 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 08/05/2020 |
Is the Reporter a Health Professional? |
Yes
|
Date Manufacturer Received | 07/22/2020 |
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 01/14/2020 |
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 |