Brand Name | ACCESS |
Type of Device | SET, BLOOD TRANSFUSION |
Manufacturer (Section D) |
BAXTER HEALTHCARE - HAINA, SAN CRISTOBAL |
parque industrial itabo |
zona |
haina |
DR |
|
Manufacturer (Section G) |
BAXTER HEALTHCARE - HAINA, SAN CRISTOBAL |
parque industrial itabo |
zona |
haina |
DR
|
|
Manufacturer Contact |
kinga
almasan
|
25212 w. illinois route 120 |
round lake, IL 60073
|
2242702068
|
|
MDR Report Key | 4673417 |
MDR Text Key | 5688520 |
Report Number | 1416980-2015-15735 |
Device Sequence Number | 1 |
Product Code |
BRZ
|
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K993120 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
Other,Company Representative |
Reporter Occupation |
Other Health Care Professional
|
Type of Report
| Initial,Followup |
Report Date |
03/20/2015 |
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 Expiration Date | 09/17/2019 |
Device Catalogue Number | 2C6750H |
Device Lot Number | DR14I17017 |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
Yes
|
Initial Date Manufacturer Received |
04/27/2015
|
Initial Date FDA Received | 04/09/2015 |
Supplement Dates Manufacturer Received | Not provided
|
Supplement Dates FDA Received | 05/14/2015
|
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Date Device Manufactured | 09/17/2014 |
Is the Device Single Use? |
Yes
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
Unknown
|
Patient Sequence Number | 1 |
Treatment | SIGMA SPECTRUM PUMP |
|
|