FDA Adverse Event
Malfunction
Summary report: N
UNICEL® DXC 600 PRO SYNCHRON® CLINICAL SYSTEM
MDR report key: 1882913
·
Received October 26, 2010
Report
- Report Number
- 2050012-2010-01074
- Event Type
- Malfunction
- Date Received
- October 26, 2010
- Date of Event
- September 26, 2010
- Report Date
- October 25, 2010
- Manufacturer
- BECKMAN COULTER INC.
- Product Code
- JJE
- PMA / PMN Number
- K042291
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- IL, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A FIELD SERVICE ENGINEER (FSE) WENT ON-SITE AND CLEANED OFF MUCOUS-LIKE OBSTRUCTION FROM GRAVITY CANISTER, WASTE CANISTER AND TUBINGS. FSE ALSO REPLACED A VALVE DUE TO WASH CONCENTRATE NOT BEING ASPIRATED.
Description of Event or Problem · 1
A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) REGARDING FLUID LEAKING IN THE LOWER RIGHT PORTION OF THE SYSTEM BELOW THE CC (CARTRIDGE CHEMISTRY) REAGENT CAROUSEL. NO INJURY WAS REPORTED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNICEL® DXC 600 PRO SYNCHRON® CLINICAL SYSTEM | CLINICAL CHEMISTRY ANALYZER | JJE | BECKMAN COULTER INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |