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 |
|
Manufacturer (Section G) |
CAREFUSION |
10020 pacific mesa blvd |
|
san diego CA 92121 4386 |
|
Manufacturer Contact |
ade
ajibade
|
10020 pacific mesa blvd |
san diego, CA 92121-4386
|
8586172000
|
|
MDR Report Key | 5899917 |
MDR Text Key | 52858179 |
Report Number | 9616066-2016-01160 |
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 |
Manufacturer
|
Source Type |
company representative,consum |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup,Followup,Followup,Followup |
Report Date |
07/27/2016 |
1 Device was Involved in the Event |
|
1 Patient was Involved in the Event |
|
Is this an Adverse Event Report? |
Yes
|
Is this a Product Problem Report? |
No
|
Device Operator |
Health Professional
|
Device Model Number | PRI TUBING |
Device Catalogue Number | PRI TUBING |
Was Device Available for Evaluation? |
No
|
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
07/27/2016
|
Initial Date FDA Received | 08/24/2016 |
Supplement Dates Manufacturer Received | Not provided Not provided Not provided Not provided Not provided Not provided
|
Supplement Dates FDA Received | 09/19/2016 10/05/2016 10/19/2016 11/04/2016 11/10/2016 03/28/2017
|
Was Device Evaluated by Manufacturer? |
No
|
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 |
Patient Outcome(s) |
Death;
|