FDA Adverse Event
Malfunction
Summary report: N
SYNCHRON® CX5 DELTA CLINICAL SYSTEM
MDR report key: 2083763
·
Received May 10, 2011
Report
- Report Number
- 2050012-2011-01604
- Event Type
- Malfunction
- Date Received
- May 10, 2011
- Date of Event
- April 14, 2011
- Report Date
- April 14, 2011
- Manufacturer
- BECKMAN COULTER INC.
- Product Code
- JJE
- PMA / PMN Number
- K881495
- Removal / Correction Number
- N/A
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- CA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
BCI FIELD SERVICE ENGINEER (FSE) WAS DISPATCHED FOR THIS EVENT. FSE REPLACED THE WASH STATION TOWER AND VERIFIED REPAIR.
Description of Event or Problem · 1
A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) TO REPORT THAT THE Y16 PORT FITTING OF THE SYNCHRON CX5 DELTA CLINICAL SYSTEM IS LOOSE AND LEAKS EACH TIME THE WASH TOWER PRIMES. NO REPORTS OF DEATH OR INJURY HAVE BEEN REPORTED IN CONNECTION WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHRON® CX5 DELTA CLINICAL SYSTEM | CLINICAL CHEMISTRY ANALYZER | JJE | BECKMAN COULTER INC. | CX5 DELTA | N/A |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |