BD FACSLYRIC¿ 3L12C INSTRUMENT CEIVD

Description of Event or Problem

IT WAS REPORTED THAT WHILE USING BD FACSLYRIC¿ 3L12C INSTRUMENT CEIVD CARRY OVER INVOLVING PATIENT SAMPLES OCCURRED. NO INJURIES WERE REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IN FACT, THE PINCH VALVE ISSUE CAN CAUSE THE SIT FLUSH TO NOT BE PERFORMED SUFFICIENTLY, WHICH CAN THEN LEAD TO SAMPLE CARRYOVER. WERE PATIENT SAMPLES CONTAMINATED OR WAS THERE CARRYOVER (CROSS-CONTAMINATION/MIXING) BETWEEN PATIENT SAMPLES? IF NO, NO FURTHER QUESTIONS REQUIRED. PATIENT SAMPLES CONTAMINATED, CARRYOVER BETWEEN PATIENT SAMPLES, UNKNOWN - GO TO QUESTION #2.: CARRYOVER BETWEEN PATIENT SAMPLES.

Additional Manufacturer Narrative

H.3. A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.

Additional Manufacturer Narrative

H.6 INVESTIGATION SUMMARY: BASED ON THE INVESTIGATION RESULTS, THE REPORTED ISSUE FOR THE CARRYOVER WAS CONFIRMED. INVESTIGATION RESULTS THAT WERE PERFORMED ON THE INDICATED FAILURE MODE WERE THE FOLLOWING: THE POTENTIAL CAUSE FOR THE CARRYOVER WAS A FAULTY VALVE. THE FIELD SERVICE REPRESENTATIVE (FSR) REPLACED THE V8 VALVE. THE CLAMPING VALVE WAS EXCHANGED FOR A CHAMBER VALVE. AFTER THE REPLACEMENT, THE INSTRUMENT WAS TESTED AND WAS CONFIRMED TO BE PERFORMING ACCORDING TO SPECIFICATIONS.

Description of Event or Problem

IT WAS REPORTED THAT WHILE USING BD FACSLYRIC¿ 3L12C INSTRUMENT CEIVD CARRY OVER INVOLVING PATIENT SAMPLES OCCURRED. NO INJURIES WERE REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IN FACT, THE PINCH VALVE ISSUE CAN CAUSE THE SIT FLUSH TO NOT BE PERFORMED SUFFICIENTLY, WHICH CAN THEN LEAD TO SAMPLE CARRYOVER. WERE PATIENT SAMPLES CONTAMINATED OR WAS THERE CARRYOVER (CROSS-CONTAMINATION/MIXING) BETWEEN PATIENT SAMPLES? IF NO, NO FURTHER QUESTIONS REQUIRED. PATIENT SAMPLES CONTAMINATED, CARRYOVER BETWEEN PATIENT SAMPLES, UNKNOWN - GO TO QUESTION #2: CARRYOVER BETWEEN PATIENT SAMPLES.