Brand Name | ALARIS PUMP MODULE ADMINSTRATION SET |
Type of Device | SET, ADMINISTRATION, INFUSION |
Manufacturer (Section D) |
CAREFUSION |
10020 pacific mesa blvd |
san diego CA 92121 4386 |
|
MDR Report Key | 8632231 |
MDR Text Key | 145781561 |
Report Number | 9616066-2019-01399 |
Device Sequence Number | 1 |
Product Code |
FPA
|
UDI-Device Identifier | 07613203021012 |
UDI-Public | 7613203021012 |
Combination Product (y/n) | N |
PMA/PMN Number | K944320 |
Number of Events Reported | 1 |
Summary Report (Y/N) | N |
Report Source |
Manufacturer
|
Source Type |
company representative,health |
Type of Report
| Initial,Followup |
Report Date |
04/23/2019 |
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 | 02/05/2022 |
Device Model Number | 2420-0007 |
Device Catalogue Number | 2420-0007 |
Device Lot Number | 19025335 |
Was Device Available for Evaluation? |
Device Returned to Manufacturer
|
Date Returned to Manufacturer | 04/30/2019 |
Initial Date Manufacturer Received |
Not provided
|
Initial Date FDA Received | 05/22/2019 |
Supplement Dates Manufacturer Received | Not provided
|
Supplement Dates FDA Received | 07/29/2019
|
Is This a Reprocessed and Reused Single-Use Device? |
No
|
Patient Sequence Number | 1 |
Treatment | 8100,8015, THERAPY DATE (B)(6) 2019; 8100,8015, THERAPY DATE (B)(6) 2019 |
Patient Age | 3 YR |
Patient Weight | 16 |
|
|