BD FACS¿ LYSE WASH ASSISTANT

Additional Manufacturer Narrative

THE FOLLOWING FIELD HAS BEEN UPDATED WITH CORRECTED INFORMATION: H.6 IMDRF ANNEX G: G04034 H.6 INVESTIGATION SUMMARY: BASED ON THE INVESTIGATION RESULTS, THE REPORTED ISSUE OF THE CUSTOMER EXPERIENCING CONTAMINATION AND 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 CONTAMINATION AND CARRYOVER WAS DETERMINED TO BE LINKED TO A CLOGGED CONNECTOR. THE ISSUE WAS RESOLVED AFTER THE WASH NEEDLE RINSE HOSE WAS REPLACED AND A LONG CLEAN WAS PERFORMED AT THE CUSTOMER¿S SITE FROM STOCK ON HAND. 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 OF THE BD FACS¿ LYSE WASH ASSISTANT, CARRYOVER INVOLVING PATIENT SAMPLES WAS OBSERVED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: (B)(6).

Additional Manufacturer Narrative

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

Description of Event or Problem

IT WAS REPORTED THAT DURING USE OF THE BD FACS¿ LYSE WASH ASSISTANT, CARRYOVER INVOLVING PATIENT SAMPLES WAS OBSERVED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CLIENT REPORTS THAT THEY NOTICED THE CONTAMINATION PROBLEM WITH THEIR INSTRUMENT.