FDA Adverse Event
Summary report: N
ALARIS SMARTSITE
MDR report key: 3113335
·
Received April 26, 2013
Report
- Report Number
- 3113335
- Date Received
- April 26, 2013
- Date of Event
- April 12, 2013
- Report Date
- April 26, 2013
- Manufacturer
- CAREFUSION
- Product Code
- FPA
- Report Source
- User Facility report
- Reporter Location
- CA, US
- Reporter Occupation
- RISK MANAGER
Narratives
Description of Event or Problem · 1
A NURSE IN PRE-OPERATIVE UNIT FOUND A PRIMARY IV TUBING WITH A RED DISCOLORATION ON THE INTERIOR OF THE "SPIKE" THAT IS USED TO ATTACH TUBING TO IV BAG. OTHER TUBINGS WERE INSPECTED AND NOT FOUND TO HAVE THIS DISCOLORATION. IT WAS CAUGHT BEFORE IT WAS USED ON A PATIENT.======================MANUFACTURER RESPONSE FOR PRIMARY IV TUBING/ ALARIS SMARTSITE GRAVITY SET, ALARIS SMARTSITE GRAVITY SET (PER SITE REPORTER).======================THEY ASKED THAT THE TUBING BE SENT TO THEM AND STATED THEY HAD NOT ENCOUNTERED THIS PROBLEM BEFORE.WHAT WAS THE ORIGINAL INTENDED PROCEDURE?NA.DEVICE #1IS THIS A LABORATORY DEVICE OR LABORATORY TEST?NO.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 180762 | ALARIS SMARTSITE | SET, ADMINISTRATION, INTRAVASCULAR | FPA | CAREFUSION | * | H370108026881G |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | * |