FDA Adverse Event
Malfunction
Summary report: N
SYNCHRON® CX9 ALX CLINICAL SYSTEM
MDR report key: 2103133
·
Received May 25, 2011
Report
- Report Number
- 2050012-2011-01911
- Event Type
- Malfunction
- Date Received
- May 25, 2011
- Date of Event
- April 25, 2011
- Report Date
- April 25, 2011
- Manufacturer
- BECKMAN COULTER INC.
- Product Code
- JJE
- PMA / PMN Number
- K950958
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
BCI FIELD SERVICE ENGINEER (FSE) FOUND THE INTERFACE DRAIN HOSE HAD RIPPED. FSE REPLACED THE INTERFACE DRAIN HOSE, CLEANED OUT THE WASTE SUMP AND VERIFIED REPAIR PER ESTABLISHED PROCEDURES.
Description of Event or Problem · 1
A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) TO REPORT WASTE FLUID LEAKING FROM BOTTOM OF THE SYNCHRON CX9 ALX INSTRUMENT. NO EFFECT TO PATIENT OR USER WAS REPORTED WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHRON® CX9 ALX CLINICAL SYSTEM | CLINICAL CHEMISTRY ANALYZER | JJE | BECKMAN COULTER INC. | CX9 ALX | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |