FDA Adverse Event
Malfunction
Summary report: N
UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM
MDR report key: 2001947
·
Received February 27, 2011
Report
- Report Number
- 2050012-2011-00572
- Event Type
- Malfunction
- Date Received
- February 27, 2011
- Date of Event
- January 28, 2011
- Report Date
- January 28, 2011
- Manufacturer
- BECKMAN COULTER INC.
- Product Code
- JJE
- PMA / PMN Number
- K060256
- Removal / Correction Number
- N/A
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
CUSTOMER TECHNICAL SUPPORT (CTS) ASSISTED THE CUSTOMER WITH TROUBLESHOOTING. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED AND DISCOVERED A CLOG IN THE WASTE CANISTER AND ALSO IN THE WASTE VALVE. THE FSE CLEANED THE VALVE, PRIMED TWENTY (20) TIMES WITH NO PROBLEMS, AND VERIFIED THE REPAIR PER ESTABLISHED PROCEDURES.
Description of Event or Problem · 1
A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) STATING THAT WHEN THE UNICEL DXC 600I SYNCHRON ACCESS CLINICAL SYSTEM GENERATED A HYDRO NO RESPONSE ERROR, THE OPERATOR OPENED THE HYDRO INSTRUMENT DOOR AND DISCOVERED A PUDDLE OF FLUID. NO INJURY OR OPERATOR EXPOSURE WAS REPORTED FOR THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNICEL® DXC 600I SYNCHRON® ACCESS® CLINICAL SYSTEM | CLINICAL CHEMISTRY ANALYZER | JJE | BECKMAN COULTER INC. | DXC 600I | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |