BD FACS SAMPLE PREP ASSISTANT III

Additional Manufacturer Narrative

COMMON DEVICE NAME: AUTOMATED PIPETTING, DILUTING AND SPECIMEN PROCESSING WORKSTATIONS FOR FLOW CYTOMETRIC ANALYSIS. MEDICAL DEVICE EXPIRATION DATE: UNKNOWN. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. (B)(4).

Description of Event or Problem

IT WAS REPORTED THAT DURING USE WITH A BD FACS¿ SAMPLE PREP ASSISTANT III THE WASTE LINE WAS LEAKING OUTSIDE OF INSTRUMENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THERE IS A LEAK FROM THE SIDE OF THE INSTRUMENT WHERE THE TANKS ARE, ON THE BENCH. IT IS NOT CLEAR WHERE THE LEAK COMES FROM. WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? NO. WAS THE LEAK IN A CUSTOMER ACCESSIBLE LOCATION? YES. WHAT WAS THE FLUID THAT LEAKED? UNKNOWN. IF SO WAS THERE LEAKED FLUID IN UNDER PRESSURE? NO. WHAT IS THE SOURCE OF LEAK. WASTE LINE OR NON-WASTE LINE? UNKNOWN. IF WASTE LINE, WHETHER IT IS MIXED WITH BLEACH OR CONTAMINATION? -- WAS THE CUSTOMER EXPOSED TO BLOOD OR BODILY FLUIDS? NO. WAS THERE ANY PHYSICAL HARM TO THE CUSTOMER AS A RESULT OF THE LEAK? NO¿ ADDITIONAL INFO FROM THE WORK ORDER NOTES: LEAK FOUND ON WASTE LINE FROM FLUIDIC TANK AT CONNECTOR, REPLACED CONNECTOR, NO FURTHER ISSUES. WASTE LINE LEAKING , OUTSIDE OF INSTRUMENT, ACCESSIBLE BY CUSTOMER, WAS THE CUSTOMER EXPOSED TO BLOOD OR BODILY FLUIDS? NO. WAS THERE ANY PHYSICAL HARM TO THE CUSTOMER AS A RESULT OF THE LEAK? NO.

Description of Event or Problem

IT WAS REPORTED THAT DURING USE WITH A BD FACS¿ SAMPLE PREP ASSISTANT III THE WASTE LINE WAS LEAKING OUTSIDE OF INSTRUMENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THERE IS A LEAK FROM THE SIDE OF THE INSTRUMENT WHERE THE TANKS ARE, ON THE BENCH. IT IS NOT CLEAR WHERE THE LEAK COMES FROM. WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? NO . WAS THE LEAK IN A CUSTOMER ACCESSIBLE LOCATION? YES. WHAT WAS THE FLUID THAT LEAKED? UNKNOWN . IF SO WAS THERE LEAKED FLUID IN UNDER PRESSURE? NO . WHAT IS THE SOURCE OF LEAK -- WASTE LINE OR NON-WASTE LINE? UNKNOWN IF WASTE LINE, WHETHER IT IS MIXED WITH BLEACH OR CONTAMINATION? -- WAS THE CUSTOMER EXPOSED TO BLOOD OR BODILY FLUIDS? NO . WAS THERE ANY PHYSICAL HARM TO THE CUSTOMER AS A RESULT OF THE LEAK? NO¿. ADDITIONAL INFO FROM THE WORK ORDER NOTES: LEAK FOUND ON WASTE LINE FROM FLUIDIC TANK AT CONNECTOR, REPLACED CONNECTOR, NO FURTHER ISSUES WASTE LINE LEAKING , OUTSIDE OF INSTRUMENT, ACCESSIBLE BY CUSTOMER, WAS THE CUSTOMER EXPOSED TO BLOOD OR BODILY FLUIDS? NO. WAS THERE ANY PHYSICAL HARM TO THE CUSTOMER AS A RESULT OF THE LEAK? NO.

Additional Manufacturer Narrative

INVESTIGATION SUMMARY CUSTOMER REPORTED THAT THE SPA IS LEAKING. THE SCOPE OF ISSUE IS LIMITED TO PART: 647205 SPAIII AND SERIAL NUMBER: (B)(6) REVIEW OF THE DHR FOR SERIAL NUMBER: (B)(6) WAS REVIEWED. THE INSTRUMENT MET ALL THE MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. THERE ARE 0 QNS RELATED TO THE REPORTED ISSUE. DATE RANGE (DATE OF INCIDENT TO 12 MONTHS BACK) FROM 01SEP2019 TO DATE 01SEP2020 (ROLLING 12 MONTHS). THIS IS THE ONLY COMPLAINT RELATED TO THE REPORTED COMPLAINT. DATE RANGE (DATE OF INCIDENT TO 12 MONTHS BACK) FROM 01SEP2019 TO DATE 01SEP2020 (ROLLING 12 MONTHS) RELATED COMPLAINT(S) NUMBER: (B)(4) (THIS COMPLAINT) FSE FOUND A LEAK ON THE SIDE OF THE INSTRUMENT WHERE THE TANKS ARE ON THE BENCH. THE LEAK WAS FOUND ON THE WASTE LINE FROM THE FLUIDIC TANK AT THE QUICK CONNECT CONNECTOR. THE CONNECTOR WAS REPLACED. NO FURTHER ISSUES FOUND. NO ONE WAS EXPOSED TO ANY BIOLOGICAL HAZARDS OR BODILY FLUIDS. BASED ON THE INVESTIGATION RESULT, AND THE FSE¿S REPORT THE ROOT CAUSE WAS DEFECTIVE QUICK CONNECT CONNECTOR. BASED ON THE INVESTIGATION RESULTS AND THE FSE REPORT THE COMPLAINT WAS CONFIRMED.