CELL-DYN SMS

Additional Manufacturer Narrative

THE CUSTOMER REPORTED A BURNING ODOR AND VISIBLE SMOKE COMING FROM THE CELL-DYN SMS, SERIAL NUMBER (B)(4). THE CUSTOMER POWERED DOWN THE SYSTEM AND DISCONNECTED IT FROM THE POWER SUPPLY. FIELD SERVICE THEN REPLACED THE PRESSURE PUMP ASSEMBLY, SMS ON THE CELL-DYN SMS (SLIDE MAKING AND STAINING SYSTEM) AND RETURNED THE PART FOR INVESTIGATION. DURING INSPECTION OF THE PRESSURE PUMP ASSEMBLY, THERE WERE NO SIGNS OF BURNS OR SMOKE, BUT NOTABLE HARD PARTICLE DEPOSITS IN THE INTAKE CHAMBER AND VALVE. IT WAS OBSERVED THAT THE PUMP COULD TURN ON BUT THE OUTPUT PRESSURE MEASURED AT HALF THE REQUIRED SPECIFICATION, WHICH MAY HAVE CAUSED THE PUMP TO KEEP PUMPING TO ACHIEVE THE LEVEL OF INSTRUMENT REQUIREMENT. AS A RESULT, THIS MAY HAVE LED TO THE PUMP OVERWORKING AND POSSIBLY OVERHEATING, WHICH COULD HAVE CAUSED THE ODOR OBSERVED BY THE USER. THE ISSUE WAS RESOLVED BY REPLACING THE PUMP AT THE CUSTOMER SITE. A REVIEW OF HISTORICAL DATA DID NOT IDENTIFY ANY ADVERSE TRENDS. ADDITIONALLY, LABELING WAS REVIEWED AND ADEQUATELY ADDRESSES THE CUSTOMER ISSUE. BASED ON THE INVESTIGATION, A PRODUCT DEFICIENCY WAS NOT IDENTIFIED FOR THE CELL-DYN SMS.

Additional Manufacturer Narrative

AN EVALUATION IS IN PROCESS. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN THE EVALUATION IS COMPLETE.

Description of Event or Problem

THE CUSTOMER REPORTED A BURNING ODOR AND VISIBLE SMOKE COMING FROM THE CELL DYN SMS. THE CUSTOMER POWERED DOWN THE SYSTEM AND DISCONNECTED IT FROM THE POWER SUPPLY. THERE WAS NO IMPACT TO PATIENT MANAGEMENT, USER SAFETY, OR FACILITY DAMAGE REPORTED.