COULTER LH 750 SLIDEMAKER
Received Jun 23, 2012 · Event occurred May 29, 2012
Report 1061932-2012-01959 · MDR key 2626896
Device
Generic name
Spinner, Slide, Automated
Manufacturer
Beckman Coulter, Inc.Model number
NACatalog number
6605633
Lot number
NA
Product problems
- Hole In Material
- Moisture Damage
Patient
Not reported
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
CUSTOMER REPORTED TO BECKMAN COULTER, INC (BEC) THAT THERE WAS SOME MOISTURE IN THE TRAY UNDERNEATH THE SHUTTLE OF THE COULTER LH 750 SLIDEMAKER. 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 5-10 ML OF ISOTON IN THE UNIT. THE FSE FOUND A HOLE IN THE BLACK STRIPE I-BEAM TUBING THROUGH PINCH VALVE VL18. THE FSE REPLACED THE DAMAGED TUBING.
Additional Manufacturer Narrative
(B)(4).