4C -ES CELL CONTROL
Received Jun 15, 2011 · Event occurred Aug 4, 2008
Report 1061932-2011-00484 · MDR key 2175334
Device
Product problems
- Fluid/Blood Leak
Patient
UNK
- No Known Impact Or Consequence To Patient
Narrative
Description of Event or Problem
ON (B)(6) 2008, THE CUSTOMER REPORTED A POTENTIAL BIOHAZARD. A VIAL OF 4C - ES CELL CONTROL VIAL WAS LEAKING AFTER 8 PIERCES BY THE COULTER AC-T DIFF 2 ANALYZER. THE LEAK WAS MINIMAL. THE OPERATOR WAS WEARING PERSONAL PROTECTIVE EQUIPMENT AT THE TIME OF THE EVENT AND BASED UPON THE AVAILABLE INFO, THERE WAS NO EXPOSURE TO MUCOUS MEMBRANES OR OPEN LESIONS. NO REPORTS OF DEATH OR SERIOUS INJURY, AND NO AFFECT TO OPERATOR SAFETY AS A RESULT OF THIS EVENT.
Additional Manufacturer Narrative
ON (B)(4) 2008, THE FIELD SERVICE ENGINEER (FSE) EVALUATED THE ANALYZER AND DETERMINED THE ANALYZER MET SPECS. NO DEFICIENCIES IDENTIFIED WITH THE FUNCTIONS ASSOCIATED WITH PIERCING AND THE PROBE WAS NOT BENT. THE 4C ES CELL CONTROL VIALS WERE RETURNED FOR EVAL. THE VIAL FOR THE ABNORMAL LOW CONTROL HAD A VISIBLE HOLE IN THE CENTER OF THE STOPPER THAT WOULD ALLOW CONTROL MATERIAL TO LEAK. THIS EVENT HAS BEEN REPORTED AT A VERY LOW OCCURRENCE RATE ((B)(4) COMPLAINTS/YEAR) AND IS UNABLE TO BE REPRODUCED THROUGH TESTING OF THE STOPPER. ROOT CAUSE IS UNK. THIS REPORTABLE EVENT WAS IDENTIFIED DURING A RETROSPECTIVE REVIEW CONDUCTED BETWEEN (B)(4) 2008 AND (B)(4) 2010 OF COMPLAINTS FOR ADD'L REPORTABLE EVENTS.