Brand Name | ALARIS® PUMP MODULE ADMINISTRATION SET |
Type of Device | SET, ADMINISTRATION, INTRAVASCULAR |
Manufacturer (Section D) |
CAREFUSION |
10020 pacific mesa blvd |
san diego CA 92121 4386 |
|
MDR Report Key | 7567734 |
MDR Text Key | 110036000 |
Report Number | 9616066-2018-00733 |
Device Sequence Number | 1 |
Product Code |
FPA
|
Combination Product (y/n) | N |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
other |
Type of Report
| Initial,Followup |
Report Date |
05/14/2018 |
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 | 2426-0007 |
Device Catalogue Number | 2426-0007 |
Other Device ID Number | 10885403227998 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 06/07/2018 |
Initial Date Manufacturer Received |
05/14/2018 |
Initial Date FDA Received | 06/04/2018 |
Supplement Dates Manufacturer Received | 06/07/2018
|
Supplement Dates FDA Received | 06/29/2018
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Treatment | 8015, 8100, TD UNK |
|
|