FDA Adverse Event
Malfunction
Summary report: N
ALARIS
MDR report key: 6145014
·
Received December 5, 2016
Report
- Report Number
- 6145014
- Event Type
- Malfunction
- Date Received
- December 5, 2016
- Date of Event
- November 7, 2016
- Report Date
- November 9, 2016
- Manufacturer
- CAREFUSION 303, INC.
- Product Code
- FRN
- Product Problem
- Yes
- Report Source
- User Facility report
- Reporter Location
- AZ, US
- Reporter Occupation
- OTHER
Narratives
Description of Event or Problem · 1
PATIENT GETTING IV FLUID VIA PIGGYBACK AND AIR WAS IN THE IV TUBING. NO FLUID WAS INFUSING. ALARM DID NOT GO OFF. THE PUMP WAS SENT TO CLINICAL ENGINEERING AND IV TUBING AS WELL.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 795173 | ALARIS | PUMP, INFUSION | FRN | CAREFUSION 303, INC. | 8015 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | 81 YR |