COULTER LH 750 ANALYZER
Received Jun 6, 2011 · Event occurred May 6, 2011
Report 1061932-2011-00561 · MDR key 2114387
Device
Generic name
Automated Differential Cell Counter
Manufacturer
Beckman Coulter, Inc.Model number
LH 750Catalog number
6605632
Lot number
N/A
Product problems
- Break
- Detachment Of Device Component
- Sticking
Patient
Not reported
- No Consequences Or Impact To Patient
Narrative
Additional Manufacturer Narrative
PER THE CUSTOMER, A BD EDTA VACUTAINER TUBE WAS USED FOR THIS PATIENT SPECIMEN. SERVICE WAS NOT DISPATCHED FOR THIS EVENT. THE BCI CALL CENTER PERSONNEL INSTRUCTED THE CUSTOMER WITH CLEANUP AND VERIFIED INSTRUMENT OPERATION. AS PER PRODUCT LABELING, BCI URGES ITS CUSTOMERS TO COMPLY WITH ALL NATIONAL HEALTH AND SAFETY STANDARDS SUCH AS THE USE OF BARRIER PROTECTION. THIS MAY INCLUDE, BUT IT IS NOT LIMITED TO, PROTECTIVE EYEWEAR, GLOVES, AND SUITABLE LABORATORY ATTIRE WHEN OPERATING OR MAINTAINING THIS OR ANY OTHER AUTOMATED LABORATORY ANALYZER.
Description of Event or Problem
A CUSTOMER CONTACTED BECKMAN COULTER INC (BCI) STATING THAT A PATIENT TUBE IN THE CASSETTE LOCATED IN THE COULTER LH 750 ANALYZER WAS STUCK ON THE STRIPPER PLATE AND THE CAP FROM THE SPECIMEN TUBE CAME OFF. THE SPECIMEN BLOOD CONTENTS SPILLED ONTO THE ROCKERBED OF THE INSTRUMENT. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (GLOVES, LAB COAT AND GLASSES). THERE WAS NO BLOOD EXPOSURE TO MUCOUS MEMBRANES (NOSE, EYE AND MOUTH) OR OPEN WOUNDS; NO ONE SOUGHT MEDICAL ATTENTION. THERE WAS NO DEATH, INJURY OR CHANGE TO PATIENT TREATMENT ASSOCIATED WITH THIS EVENT.