FDA Adverse Event
Malfunction
Summary report: N
UNICEL® DXC 600 PRO SYNCHRON® CLINICAL SYSTEM
MDR report key: 2073380
·
Received May 1, 2011
Report
- Report Number
- 2050012-2011-01294
- Event Type
- Malfunction
- Date Received
- May 1, 2011
- Date of Event
- March 31, 2011
- Report Date
- March 31, 2011
- Manufacturer
- BECKMAN COULTER, INC.
- Product Code
- JJE
- PMA / PMN Number
- K042291
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- SC, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE CUSTOMER STATED THAT WASTE FLUID WAS LEAKING FROM THE WASTE CANISTER ONTO FLOOR, GIVING FLOOD IN PRIMARY VACUUM ACCUMULATOR SWITCH 22 MESSAGE, AND THE WASTE B SUMP WAS NOT DRAINING. THE CUSTOMER POWERED DOWN AND REBOOTED THE INSTRUMENT, RESETTING ALL THE VALVES IN THE PROCESS. THE DI WATER THAT HAD ENTERED THE AIR LINE WAS PURGED VIA THE AIR REGULATORS TO THE HYDRO TRAY. THE CUSTOMER RESUMED OPERATION WITHOUT FURTHER PROBLEMS. CUSTOMER RESOLVED THE ISSUE.
Description of Event or Problem · 1
A CUSTOMER CONTACTED BECKMAN COULTER, INC. (BCI) IN REGARDS TO A FLUID LEAK ON UNICEL DXC 600 PRO SYNCHRON CLINICAL SYSTEM. NO INJURY WAS REPORTED AND THERE WAS NO EXPOSURE TO UNCOVERED WOUNDS OR MUCOUS MEMBRANES.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNICEL® DXC 600 PRO SYNCHRON® CLINICAL SYSTEM | CLINICAL CHEMSTRY ANALYZER | JJE | BECKMAN COULTER, INC. | DXC 600 PRO | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |