FDA Adverse Event
Malfunction
Summary report: N
SYNCHRON LX®I 725 SYSTEM
MDR report key: 2103085
·
Received May 25, 2011
Report
- Report Number
- 2050012-2011-01891
- 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
- JGS
- PMA / PMN Number
- K023049
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MI, US
- Reporter Occupation
- MEDICAL TECHNOLOGIST
Narratives
Additional Manufacturer Narrative · 1
BCI FIELD SERVICE ENGINEER (FSE) REPLACED THE AUTOGLOSS TUBING AND THE LEVEL SENSE BEAD, THEN VERIFIED REPAIRS.
Description of Event or Problem · 1
A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) TO REPORT THE SYNCHRON LXI 725 SYSTEM'S CAP PIERCER WICK WAS NOT GETTING LUBRICATED WITH AUTOGLOSS AND THAT THE LINEAR PUMP TUBING APPEARED TO BE THE CAUSE OF THE LEAK. NO EFFECT TO PATIENT OR USER WAS REPORTED IN CONNECTION WITH THIS EVENT.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | SYNCHRON LX®I 725 SYSTEM | CLINICAL CHEMISTRY ANALYZER | JGS | BECKMAN COULTER INC. | LXI 725 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |