BD FACS SAMPLE PREP ASSISTANT III (BD SPA III)
Received Aug 25, 2014 · Event occurred Jul 10, 2014
Report 2916719-2014-00001 · MDR key 4060420
Device
Product problems
- Fitting Problem
Patient
Not reported
- No Patient Involvement
Narrative
Description of Event or Problem
ON (B)(6) 2014, TECAN WAS NOTIFIED BY (B)(4) OF AN ADVERSE EVENT WITH THE BD SPA III. REFERENCE MFR REPORT #2916837-2014-00001. A BD FIELD SERVICE PREP WAS REPAIRING A BD SPA III AT A CUSTOMER SITE. THE EXIT WASTE QUICK CONNECT ON THE FLUIDICS TOWER OF THE BD SPA III WAS BROKEN. 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 ENGINEERS FACE. THE ENGINEER WAS IMMEDIATELY TAKEN TO THE ACCIDENT AND EMERGENCY DEPARTMENT FOR A (B)(6) INJECTION AND IMMEDIATE (B)(6) POST-EXPOSURE PROPHYLAXIS AND TREATMENT CONTINUES.
Additional Manufacturer Narrative
TECAN WAS NOTIFIED OF THE ADVERSE EVENT BY (B)(4) ON (B)(6) 2014. (B)(4) INDICATED THAT THE EVENT WAS NOT A RESULT OF A MALFUNCTION OF THE INSTRUMENT, BUT EMPLOYEE ERROR IN CONDUCTING THE REPAIR. NO ASSISTANCE OR CORRECTIVE ACTION FROM TECAN SYSTEM WAS REQUIRED BY (B)(4).