BD FACS SAMPLE PREP ASSISTANT III (BD SPA III
Received Aug 8, 2014 · Event occurred Jul 10, 2014
Report 2916837-2014-00001 · MDR key 4006471
Device
Generic name
Bd Spa Iii
Manufacturer
Tecan Systems IncModel number
647205Catalog number
647205
Lot number
NA
Product problems
- Break
- Fluid/Blood Leak
- Mechanical Jam
Patient
NA
- Exposure to Body Fluids
Narrative
Description of Event or Problem
ON (B)(6) 2014 A (B)(6) BD FIELD SERVICE ENGINEER (FSE) AT (B)(6), DEPT OF HAEMATOLOGY, (B)(6) WAS EXPOSED TO BIOHAZARD WASTE DURING A SERVICE VISIT. REPORTED TO BD BIOSCIENCES ON (B)(6) 2014. THE EXIT WASTE QUICK-CONNECT ON THE FLUIDICS TOWER OF THE BD FACS SPA III WAS BROKEN AND THE ENGINEER'S VISIT WAS TO RESOLVE THE SITUATION. THE MALE PART OF THE FITTING WAS JAMMED IN THE FEMALE PART. THE ENGINEER PROCEEDED TO REPLACE THE FEMALE QUICK-DISCONNECT MOUNTED IN THE FLUIDICS TOWER. DECONTAMINATION OF THE SYSTEM BY THE CUSTOMER WAS NOT POSSIBLE DUE TO THE FAILURE MODE. UPON CUTTING THE TUBING TO THE FLUIDIC FITTING, RESIDUAL PRESSURE IN THE WASTE TUBE SPRAYED BIOHAZARDOUS WASTE AT THE ENGINEER'S FACE. THE ENGINEER WAS IMMEDIATELY TAKEN TO THE ACCIDENT AND EMERGENCY DEPT (ER) FOR A HEPATITIS B INJECTION AND IMMEDIATE HIV POST-EXPOSURE PROPHYLAXIS (PEP) AND TREATMENT CONTINUES.
Remedial action
- Repair