FDA Adverse Event
Malfunction
Summary report: N
COULTER LH SLIDEMAKER
MDR report key: 2495017
·
Received March 18, 2012
Report
- Report Number
- 1061932-2012-00869
- Event Type
- Malfunction
- Date Received
- March 18, 2012
- Date of Event
- February 23, 2012
- Report Date
- February 23, 2012
- Manufacturer
- BECKMAN COULTER, INC.
- Product Code
- GKJ
- PMA / PMN Number
- CLASS I EXEM
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- MD, 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 THE COULTER LH 750 SLIDEMAKER WAS LEAKING A CLEAR FLUID FROM THE FRONT, LEFT SIDE OF THE UNIT, UNDER THE AREA OF ASPIRATION PUMP. CUSTOMER REPORTED THAT THE VOLUME OF THE LEAK WAS 100 ML. THERE WAS NO REPORT OF PATIENT RESULTS AFFECTED. THERE WAS NO REPORT OF ANY ADVERSE EVENT OR INJURY REQUIRING MEDICAL INTERVENTION OR PATIENT TREATMENT. BEC FIELD SERVICE ENGINEER (FSE) OBSERVED ISOTON LEAKING FROM A HOLE DUE TO WEAR IN THE I-BEAM TUBING AT PINCH VALVE VL120. THE FSE OBSERVED THAT THE LEAK WAS CONTAINED WITHIN THE UNIT. THE FSE REPLACED THE TUBING. THE COULTER LH 750 SLIDEMAKER IS CURRENTLY PERFORMING WITHIN PUBLISHED SPECIFICATIONS.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 1 | COULTER LH SLIDEMAKER | SPINNER, SLIDE, AUTOMATED | GKJ | BECKMAN COULTER, INC. | LH 750 | NA |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 |