FDA Adverse Event
Malfunction
Summary report: N
UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM
MDR report key: 2621939
·
Received June 19, 2012
Report
- Report Number
- 1061932-2012-01953
- Event Type
- Malfunction
- Date Received
- June 19, 2012
- Date of Event
- May 25, 2012
- Report Date
- May 25, 2012
- Manufacturer
- BECKMAN COULTER, INC.
- Product Code
- GKZ
- PMA / PMN Number
- K081930
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- PA, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
CUSTOMER REPORTED TO BECKMAN COULTER, INC (BEC) THAT 2-3 MILLILITERS OF BLOOD SPILLED FROM THE FITTING ON THE BLOOD SAMPLING VALVE (BSV) BETWEEN FITTING 2 AND 4 OF THE UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM. CUSTOMER REPORTED THAT THE SPILL WAS CONTAINED WITHIN THE UNIT. CUSTOMER REPORTED THAT PATIENT RESULTS WERE NOT AFFECTED. THERE WAS NO REPORT OF ANY ADVERSE EVENT OR INJURY REQUIRING MEDICAL INTERVENTION OR PATIENT TREATMENT. BEC FIELD SERVICE ENGINEER (FSE) FOUND THE ASPIRATION TUBING AT FITTING 2 WAS DISCONNECTED FROM THE BSV. THE FSE PROPERLY CUT EDGE OF TUBING AND INSTALLED THE TUBING CORRECTLY.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM | COUNTER, DIFFERENTIAL CELL | GKZ | BECKMAN COULTER, INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |