FDA Adverse Event
Malfunction
Summary report: N
UNICEL DXH 800 COULTER CELLULAR ANALYSIS SYSTEM
MDR report key: 2511943
·
Received March 30, 2012
Report
- Report Number
- 1061932-2012-01078
- Event Type
- Malfunction
- Date Received
- March 30, 2012
- Date of Event
- March 8, 2012
- Report Date
- March 8, 2012
- Manufacturer
- BECKMAN COULTER, INC.
- Product Code
- GKZ
- PMA / PMN Number
- K081930
- Removal / Correction Number
- 2050012-04/05/2011-0006C
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TN, US
- Reporter Occupation
- HEALTH PROFESSIONAL
Narratives
Additional Manufacturer Narrative · 1
(B)(4).
Description of Event or Problem · 1
ON (B)(6) 2012 CUSTOMER REPORTED A LARGE CLEAR FLUID LEAK MIXED WITH SOME BLOOD INSIDE THE DXH 800 INSTRUMENT. CUSTOMER STATED THAT THE LEAK WAS TO THE LEFT OF THE SINGLE-TUBE STATION NEAR THE AIR MIX TEMPERATURE CONTROL (AMTC) MODULE. NO INJURIES WERE REPORTED AND NO ERRONEOUS PATIENT RESULTS WERE GENERATED. FIELD SERVICE ENGINEER (FSE) INSPECTED THE INSTRUMENT AND FOUND THE NUCLEATED RED BLOOD CELL (NRBC) MIXING CHAMBER WAS PLUGGED. FSE REMOVED A PLUG FROM THE NRBC MIX CHAMBER DRAIN PORT THAT WAS COMPOSED OF GRAY STOPPER DEBRIS. THIS RESOLVED THE ISSUE AND NO FURTHER LEAKS HAVE BEEN REPORTED.
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. | DXH 800 |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |