FDA Adverse Event
Malfunction
Summary report: N
UNICEL® DXC 600 PRO SYNCHRON® CLINICAL SYSTEM
MDR report key: 1863331
·
Received October 9, 2010
Report
- Report Number
- 2050012-2010-00962
- Event Type
- Malfunction
- Date Received
- October 9, 2010
- Date of Event
- August 5, 2010
- Report Date
- October 8, 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
- MD, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
BCI FIELD SERVICE ENGINEER (FSE) REPLACED AND TIGHTENED A FEW HARDWARE COMPONENTS BUT THE LEAKING PERSISTED. THE FSE DISCOVERED THE DEGASSER WAS FULL OF BUBBLES AND THE LEAK STOPPED AFTER THE DEGASSER WAS REPLACED. THE ROOT CAUSE FOR THIS EVENT WAS A HARDWARE COMPONENT, THE DEGASSER.
Description of Event or Problem · 1
A BCI FIELD SERVICE ENGINEER REPORTED ON A NEW INSTALL OF UNICEL DXC 600 PRO SYNCHRON CLINICAL SYSTEM THAT HAD A LEAKING PROBE. NO CHEMICAL EXPOSURE WAS NOTED, AND NO INJURY WAS REPORTED. THERE WAS NO EFFECT TO PATIENT OR TO USER.
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 |