FDA Adverse Event
Malfunction
Summary report: N
COULTER LH 780 HEMATOLOGY ANALYZER
MDR report key: 2635915
·
Received June 29, 2012
Report
- Report Number
- 1061932-2012-02048
- Event Type
- Malfunction
- Date Received
- June 29, 2012
- Date of Event
- June 3, 2012
- Report Date
- June 3, 2012
- Manufacturer
- BECKMAN COULTER, INC.
- Product Code
- GKZ
- PMA / PMN Number
- K061616
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- TX, 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 100 ML OF FLUID LEAKED FROM THE COULTER LH 780 HEMATOLOGY ANALYZER. CUSTOMER REPORTED THAT THE LEAK SPILLED OUTSIDE THE INSTRUMENT. 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 LEAK WAS AT THE BACKWASH MANIFOLD AT FITTING 1. THE FSE REPLACED THE TUBING AT FITTING 1 TO RESOLVE THE ISSUE.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COULTER LH 780 HEMATOLOGY ANALYZER | COUNTER, DIFFERENTIAL CELL | GKZ | BECKMAN COULTER, INC. | NA | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |