BD FACS¿ LYSE WASH ASSISTANT

Description of Event or Problem

IT WAS REPORTED THAT DURING USE WITH BD FACS LYSE WASH ASSISTANT CARRYOVER BETWEEN PATIENT SAMPLES OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (2ND OF 2 REPORTS) THE CUSTOMER REQUESTED A CHECK OF THE CELL WASH PROBE RINSING SYSTEM AS HE FOUND CARRYOVER BETWEEN ONE SAMPLE AND ANOTHER. ADDITIONAL INFORMATION REPORTED BY CUSTOMER: THE CUSTOMER FOUND CARRYOVER BETWEEN 2 PATIENT SAMPLES AND REPROCESSED AND RETESTED BOTH SAMPLES.

Additional Manufacturer Narrative

H.6 INVESTIGATION SUMMARY: BASED ON THE INVESTIGATION RESULTS, THE REPORTED ISSUE OF THE CUSTOMER EXPERIENCING CARRYOVER WAS CONFIRMED. INVESTIGATION RESULTS THAT WERE PERFORMED ON THE INDICATED FAILURE MODE WERE THE FOLLOWING: THE COMPLAINT TREND AND SERVICE NOTES WERE REVIEWED. THE POTENTIAL CAUSE FOR THE CUSTOMER EXPERIENCING CARRYOVER DUE TO CLOGGED FITTINGS AND RESTRICTORS. THE ISSUE WAS RESOLVED AFTER THE PART WAS REPLACED. NO FURTHER PROBLEMS WERE NOTED, AND THE INSTRUMENT WAS CONFIRMED TO BE FUNCTIONING AS EXPECTED. ALTHOUGH THE INSTRUMENT WAS USED FOR DIAGNOSTIC TESTING, THE ISSUE WAS RESOLVED BEFORE THE PATIENT SAMPLE RESULTS WERE USED FOR ANY DIAGNOSIS OR TREATMENT.

Description of Event or Problem

IT WAS REPORTED THAT DURING USE WITH BD FACS LYSE WASH ASSISTANT CARRYOVER BETWEEN PATIENT SAMPLES OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (2ND OF 2 REPORTS). THE CUSTOMER REQUESTED A CHECK OF THE CELL WASH PROBE RINSING SYSTEM AS HE FOUND CARRYOVER BETWEEN ONE SAMPLE AND ANOTHER. ADDITIONAL INFORMATION REPORTED BY CUSTOMER: THE CUSTOMER FOUND CARRYOVER BETWEEN 2 PATIENT SAMPLES AND REPROCESSED AND RETESTED BOTH 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.