FDA Adverse Event
Malfunction
Summary report: N
SYNCHRON CX9 ALX
MDR report key: 2132945
·
Received June 17, 2011
Report
- Report Number
- 2050012-2011-02291
- Event Type
- Malfunction
- Date Received
- June 17, 2011
- Date of Event
- May 18, 2011
- Report Date
- May 18, 2011
- Manufacturer
- BECKMAN COULTER INC.
- Product Code
- JJC
- PMA / PMN Number
- K950958
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MS, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON (B)(4) 2011. THE FSE FOUND PROBE RINSE DRAIN LINE OCCLUDED AT ELBOW FITTING TO WASTE SUMP. THE FSE CLEANED THE WASTE SUMP AND REMOVE THE FUNGAL OCCLUSIONS, AND CHANGED TUBING VENT FILTERS. HARDWARE IS THE ROOT CAUSE FOR THIS EVENT.
Description of Event or Problem · 1
A CUSTOMER CONTACTED BECKMAN COULTER INC., (BCI) AND REPORTED THAT AN UNIDENTIFIED LIQUID WAS FOUND UNDERNEATH THE SYNCHRON CX9 ALX INSTRUMENT BELOW THE HYDRO AREA. NO INJURY WAS REPORTED IN CONNECTION WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHRON CX9 ALX | CLINICAL CHEMISTRY ANALYZER | JJC | BECKMAN COULTER INC. | CX9 ALX | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |