UNICEL® DXH¿ SLIDEMAKER STAINER COULTER® CELLULAR ANALYSIS SYSTEM

Additional Manufacturer Narrative

(B)(4).

Description of Event or Problem

AN INTERNAL BECKMAN COULTER SERVICE PERSONNEL REPORTED HAVING THERMAL CONTACT WITH THE SMEAR HEATER WHILE SERVICING THE ENGINEERING PROTOTYPE OF A UNICEL DXH SLIDEMAKER STAINER COULTER CELLULAR ANALYSIS SYSTEM DURING THE DEVELOPMENT PHASE OF THE PRODUCT. THE SERVICE PERSONNEL STATED THAT THERE IS NO INDICATION IF THE SMEAR HEATER IS STILL HOT AFTER BEING TURNED OFF AND THE TEMPERATURE FOR THE HEATER CAN REACH 232 DEGREES CELSIUS (449.6 DEGREES FAHRENHEIT). NO INJURY OCCURRED AND NO MEDICAL ATTENTION WAS SOUGHT IN CONNECTION WITH THIS EVENT. IN ADDITION, THERE HAVE BEEN NO REPORTED INCIDENTS REGARDING THIS ISSUE IN THE RELEASED PRODUCT WITH SIMILAR SMEAR HEATERS SINCE PRODUCT LAUNCH IN NOVEMBER 2011. THERE ARE TWO SMEAR HEATERS (CYLINDER RODS) ON THE INSTRUMENT: ONE FOR EACH BASKET ELEVATOR ON THE SLIDEMAKER MODULE. THE HEATERS DRY THE SLIDES PRIOR TO STAINING AND EACH SMEAR HEATER CONTAINS A SHIELD WHICH ACTS AS A BARRIER TO PROTECT THE OPERATOR FROM THE SMEAR HEATER RODS. THE SHIELDS ARE DESIGNED TO ALLOW THE AIR FLOW TO PASS THROUGH THE INSTRUMENT WITHOUT OBSTRUCTION. THE SMEAR HEATER AREA IS NOT INDICATED AS AN AREA FOR CUSTOMER ACCESS IN THE INSTRUMENT'S INSTRUCTION FOR USE (IFU) AND CANNOT BE EASILY ACCESSED BY A CUSTOMER AS IT REQUIRES A TOOL TO REMOVE THE RIGHT SIDE INSTRUMENT COVER. THE SMEAR HEATER AREA MAY ALSO BE ACCESSED FROM THE FRONT OF THE INSTRUMENT BY DISENGAGING THE INTERLOCK ON THE FRONT PANEL. THERE ARE GENERAL PRECAUTIONS LISTED FOR THE INSTRUMENT; HOWEVER, NO SAFETY PRECAUTION OR WARNING LABEL IS CURRENTLY DISPLAYED IN THE SMEAR HEATER AREA OR IN THE INSTRUMENT'S IFU TO ALERT THE OPERATOR OF THE HEATER'S HIGH TEMPERATURE OR POTENTIAL BURN HAZARD. AN AUDIT WAS PERFORMED ON THE SYSTEM RISK DOCUMENTATION AND IT WAS DISCOVERED THAT THE COUNTER-MEASURE FOR THIS POTENTIAL BURN HAZARD HAD NOT BEEN IMPLEMENTED PRIOR TO PRODUCT RELEASE. AS OF (B)(4) 2013, A "HOT PART" DANGER LABEL WAS NOT IMPLEMENTED FOR THE SMEAR HEATER. FAILURE MODE IS ATTRIBUTED TO LABELING DEFICIENCY.

Additional Manufacturer Narrative

THE UNICEL DXH SLIDEMAKER STAINER COULTER CELLULAR ANALYSIS SYSTEM REFERENCED IN THE INITIAL REPORT WAS AN UNPROTECTED ENGINEERING PROTOTYPE UTILIZED DURING THE DEVELOPMENT PHASE OF THE PRODUCT. THE UNPROTECTED PROTOTYPE HAD THE SHIELDS AROUND THE SMEAR HEATER REMOVED FOR SERVICING BY ONE OF THE INTERNAL BECKMAN COULTER ENGINEERS. THE COMMERCIALIZED RELEASED SYSTEMS ARE ONLY SOLD WITH SHIELDS IN PLACE THAT ARE NOT REMOVABLE BY THE CUSTOMER. THESE SHIELDS ACT AS A BARRIER TO PROTECT THE OPERATOR FROM THE SMEAR HEATER ELEMENTS (RODS) AND THE SHIELD'S TEMPERATURE DURING NORMAL OPERATION IS AT 50 TO 52°C. IN ADDITION, A "HOT PART" SURFACE WARNING LABEL WILL BE ADDED TO THE SHIELDS AS A SECONDARY SAFETY MEASURE. WHILE THERE WAS HEATER EXPOSURE IN THE PROTOTYPE CONFIGURATION, THERE IS NO SIMILAR DEVICE ON THE MARKET WITHOUT THE HEATER SHIELDS IN PLACE AS THIS IS NOT THE CONFIGURATION FOR THE COMMERCIALIZED PRODUCT. FAILURE MODE OF THE EVENT IS ATTRIBUTED TO THE FAILURE TO IMPLEMENT CAUTION LABELING FOR A THERMAL HAZARD IDENTIFIED DURING DEVELOPMENT.