FDA Adverse Event
Malfunction
Summary report: N
SYNCHRON® CX5 DELTA CHEMISTRY ANALYZER
MDR report key: 2070068
·
Received April 26, 2011
Report
- Report Number
- 2050012-2011-01301
- Event Type
- Malfunction
- Date Received
- April 26, 2011
- Date of Event
- March 27, 2011
- Report Date
- March 27, 2011
- Manufacturer
- BECKMAN COULTER INC.
- Product Code
- JJE
- PMA / PMN Number
- K188495
- Removal / Correction Number
- N/A
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- OK, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE CUSTOMER ATTEMPTED TO TROUBLESHOOT BY SPLICING THE TUBING TOGETHER. A FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED ON (B)(4) 2011 AND REPLACED THE REAGENT SIDE WASH STATION WASTE LINE AND NO FURTHER ISSUES OCCURRED.
Description of Event or Problem · 1
A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) STATING THAT A TUBE BROKE IN THE HYDRO AREA OF THE SYNCHRON CX5 DELTA CHEMISTRY ANALYZER, CAUSING FLUID TO SPILL OUT. NO INJURY OR OPERATOR EXPOSURE WAS REPORTED FOR THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHRON® CX5 DELTA CHEMISTRY ANALYZER | CLINICAL CHEMISTRY ANALYZER | JJE | BECKMAN COULTER INC. | CX5 DELTA | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |