Brand Name | ALARIS PUMP MODULE ADMINISTRATION SET |
Type of Device | SET, ADMINISTRATION, INTRAVASCULAR |
Manufacturer (Section D) |
CAREFUSION 303, INC. |
10020 pacific mesa blvd. |
san diego CA 92121 |
|
MDR Report Key | 5976638 |
MDR Text Key | 55599876 |
Report Number | 5976638 |
Device Sequence Number | 1 |
Product Code |
FPA
|
Combination Product (y/n) | N |
Reporter Country Code | US |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
User Facility
|
Reporter Occupation |
Other
|
Type of Report
| Initial |
Report Date |
08/30/2016 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Date FDA Received | 09/26/2016 |
Is this an Adverse Event Report? |
No
|
Is this a Product Problem Report? |
Yes
|
Device Operator |
No Information
|
Device Expiration Date | 07/31/2019 |
Device Catalogue Number | 11426965 |
Other Device ID Number | 16076918 |
Was the Report Sent to FDA? |
Yes
|
Date Report Sent to FDA | 08/30/2016 |
Device Age | 1 DY |
Event Location |
Hospital
|
Date Report to Manufacturer | 08/30/2016 |
Was Device Evaluated by Manufacturer? |
Device Not Returned to Manufacturer
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Type of Device Usage |
N
|
Patient Sequence Number | 1 |
|
|