FDA Adverse Event
Malfunction
Summary report: N
SMARTSITE EXTENSION SET
MDR report key: 3883790
·
Received February 12, 2014
Report
- Report Number
- 9616066-2014-00132
- Event Type
- Malfunction
- Date Received
- February 12, 2014
- Date of Event
- January 17, 2014
- Report Date
- January 23, 2014
- Manufacturer
- SISTEMOS MEDICOS ALARIS
- Product Code
- FPA
- PMA / PMN Number
- K801614
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OH, US
- Reporter Occupation
- PHARMACIST
Narratives
Additional Manufacturer Narrative · 1
(B)(4). NO PRODUCT WILL BE RETURNED PER CUSTOMER. THE CUSTOMER'S REPORT OF TPN LEAKED FROM FILTER COULD NOT BE CONFIRMED DUE TO PRODUCT WAS DISCARDED BY THE CUSTOMER.
Description of Event or Problem · 1
THE CUSTOMER REPORTED THE TPN LEAKED FROM THE FILTER ON A PT ON THE GENERAL PEDIATRIC FLOOR. THERE WAS NO PT HARM OR MEDICAL INTERVENTION. ALTHOUGH REQUESTED, NO ADDITIONAL PT OR EVENT DETAILS WERE PROVIDED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 94272 | SMARTSITE EXTENSION SET | FPA | SISTEMOS MEDICOS ALARIS | 20029E | UNK |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | UNK |