inforMED
MalfunctionKQC

COULTER® LH 750 SLIDEMAKER

Received Jun 15, 2011 · Event occurred May 16, 2011

Report 1061932-2011-00653 · MDR key 2124627

Device

Generic name

Slidemaker

Model number

LH 750

Catalog number

6605633

Lot number

NA

Product problems

  • Fluid/Blood Leak

Patient

Not reported

  • No Consequences Or Impact To Patient

Narrative

Additional Manufacturer Narrative

A FIELD SERVICE ENGINEER (FSE) WENT ON-SITE (B)(4) 2011 AND RECONNECTED POPPED TUBING THAT WAS THE DRAIN LINE THAT GOES TO THE WASH BLOCK. FSE VERIFIED REPAIR PER ESTABLISHED PROCEDURES AND RESULTS MET PUBLISHED PERFORMANCE SPECIFICATIONS. ROOT CAUSE WAS ATTRIBUTED TO TUBING NOT BEING CONNECTED.

Description of Event or Problem

A CUSTOMER CONTACTED BECKMAN COULTER STATING A SMALL BLOODY LEAK WAS OBSERVED. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT (PPE) CONSISTING OF A LAB COAT, GLOVES AND EYE PROTECTION. NO INJURIES OCCURRED AND MEDICAL ATTENTION WAS NOT SOUGHT. THERE WAS NO REPORT OF EXPOSURE TO MUCOUS MEMBRANES OR OPEN WOUNDS.