Brand Name | ALARIS PCA MODULE 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 |
stephen
bilello
|
10020 pacific mesa blvd |
san diego, CA 92121-4386
|
8586172000
|
|
MDR Report Key | 7774130 |
MDR Text Key | 116804808 |
Report Number | 9616066-2018-01274 |
Device Sequence Number | 1 |
Product Code |
FPA
|
UDI-Device Identifier | 10885403460234 |
UDI-Public | 10885403460234 |
Combination Product (y/n) | N |
Reporter Country Code | US |
PMA/PMN Number | K790108 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,other |
Reporter Occupation |
Other
|
Type of Report
| Initial,Followup |
Report Date |
07/18/2018 |
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? |
Yes
|
Device Operator |
Health Professional
|
Device Expiration Date | 09/29/2020 |
Device Model Number | 30893-07 |
Device Catalogue Number | 30893-07 |
Device Lot Number | 17096980 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 08/06/2018 |
Is the Reporter a Health Professional? |
No
|
Initial Date Manufacturer Received |
Not provided |
Initial Date FDA Received | 08/10/2018 |
Supplement Dates Manufacturer Received | Not provided
|
Supplement Dates FDA Received | 09/10/2018
|
Was Device Evaluated by Manufacturer? |
Yes
|
Date Device Manufactured | 09/29/2017 |
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 |
Treatment | 8120,8015,SYRINGE, TD: (B)(6) 2018 |
Patient Outcome(s) |
Other;
|
|
|