FDA Adverse Event
Malfunction
Summary report: N
UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEM
MDR report key: 2110831
·
Received June 1, 2011
Report
- Report Number
- 2050012-2011-01962
- Event Type
- Malfunction
- Date Received
- June 1, 2011
- Date of Event
- May 5, 2011
- Report Date
- May 5, 2011
- Manufacturer
- BECKMAN COULTER INC.
- Product Code
- JJE
- PMA / PMN Number
- K042291
- Removal / Correction Number
- NA
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- WA, US
- Reporter Occupation
- OTHER
Narratives
Additional Manufacturer Narrative · 1
THE CUSTOMER CLEANED THE SPILL AND REPLACED THE PUMP TUBING WHICH STOPPED THE LEAK.
Description of Event or Problem · 1
A CUSTOMER CONTACTED BECKMAN COULTER INC. (BCI) STATING THE PUMP TUBING ON THE ION SELECTIVE ELECTRODE (ISE) DRAIN RETROFIT PERI PUMP BROKE CAUSING THE ISE WASTE TO SPILL ON THE FLOOR. PER CUSTOMER, THE AMOUNT OF LIQUID THAT LEAKED WAS MINIMAL (ABOUT 10 TO 15 ML) AND CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) WHEN THE LEAK WAS DISCOVERED. NO INJURY WAS REPORTED AND NO ERRONEOUS RESULTS WERE GENERATED.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNICEL® DXC 800 PRO SYNCHRON® CLINICAL SYSTEM | CLINICAL CHEMISTRY ANALYZER | JJE | BECKMAN COULTER INC. | DXC 800 PRO | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |