BD FACS¿ SAMPLE PREP ASSISTANT
Received Jun 15, 2022 · Event occurred May 25, 2022
Report 2916837-2022-00146 · MDR key 14697494
Device
Product problems
- Fluid/Blood Leak
- Fluid/Blood Leak
Patient
Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Description of Event or Problem
IT WAS REPORTED BY THE CUSTOMER THAT WHILE USING BD FACS¿ SPA III (337170 UPGRADED) WASH STATION WAS OVERFLOWING. THERE WAS NO REPORT OF USER IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER WASH TOWER OVERFLOWING. 1) WAS THE LEAK LIQUID OR AIR? LIQUID . 2) WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? NOT CONTAINED . 3) WAS THERE SPRAY OF LIQUID UNDER PRESSURE? NO . 4) WHAT WAS THE FLUID THAT LEAKED? UNKNOWN . 5) DID BIOHAZARD LEAK BEFORE OR AFTER WASTE LINE? UNKNOWN . 6) WAS THE WASTE MIXED WITH DECONTAMINATION/BLEACH? 7) WAS THE CUSTOMER/BD PERSONNEL PHYSICALLY IN CONTACT WITH THE FLUID? NO. ADDITIONAL INFORMATION: 1. WAS THE LEAK LIQUID OR AIR? (IF LIQUID/BOTH, GO TO QUESTION #2. IF AIR, NO FURTHER QUESTIONS REQUIRED.): LIQUID. 2. WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? (IF NOT CONTAINED, GOT TO QUESTION #3. IF CONTAINED, NO FURTHER QUESTIONS REQUIRED.): CONTAINED.
Additional Manufacturer Narrative
THE FOLLOWING INFORMATION FROM THE INVESTIGATION HAS BEEN CORRECTED: CHANGED FROM: "1) WAS THE LEAK LIQUID OR AIR? LIQUID. 2) WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? NOT CONTAINED . 3) WAS THERE SPRAY OF LIQUID UNDER PRESSURE? NO . 4) WHAT WAS THE FLUID THAT LEAKED? UNKNOWN . 5) DID BIOHAZARD LEAK BEFORE OR AFTER WASTE LINE? UNKNOWN . 6) WAS THE WASTE MIXED WITH DECONTAMINATION/BLEACH? 7) WAS THE CUSTOMER/BD PERSONNEL PHYSICALLY IN CONTACT WITH THE FLUID? NO" . CHANGED TO: "1. WAS THE LEAK LIQUID OR AIR? (IF LIQUID/BOTH, GO TO QUESTION #2. IF AIR, NO FURTHER QUESTIONS REQUIRED.): LIQUID. 2. WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? (IF NOT CONTAINED, GOT TO QUESTION #3. IF CONTAINED, NO FURTHER QUESTIONS REQUIRED.): CONTAINED". THIS SUPPLEMENTAL TO CANCEL MFR #2916837-2022-00146. CORRECTIONS MADE CHANGED THE REPORTABILITY. THIS MDR SHOULD BE CONSIDERED CANCELED.
Description of Event or Problem
IT WAS REPORTED BY THE CUSTOMER THAT WHILE USING BD FACS¿ SPA III (337170 UPGRADED) WASH STATION WAS OVERFLOWING. THERE WAS NO REPORT OF USER IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER WASH TOWER OVERFLOWING. WAS THE LEAK LIQUID OR AIR? LIQUID. WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? NOT CONTAINED. WAS THERE SPRAY OF LIQUID UNDER PRESSURE? NO. WHAT WAS THE FLUID THAT LEAKED? UNKNOWN. DID BIOHAZARD LEAK BEFORE OR AFTER WASTE LINE? UNKNOWN. WAS THE WASTE MIXED WITH DECONTAMINATION/BLEACH? WAS THE CUSTOMER/BD PERSONNEL PHYSICALLY IN CONTACT WITH THE FLUID? NO.
Additional Manufacturer Narrative
A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED. COMMON DEVICE NAME: AUTOMATED PIPETTING, DILUTING AND SPECIMEN PROCESSING WORKSTATIONS FOR FLOW CYTOMETRIC ANALYSIS.