BD FACS¿ LYSE WASH ASSISTANT

Description of Event or Problem

IT WAS REPORTED THAT DURING USE WITH BD FACS¿ LYSE WASH ASSISTANT CARRYOVER OF PATIENT SAMPLE OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM DUTCH TO ENGLISH: WITH THIS LYSIS WASH WE SEE QUITE A LOT OF CARRY OVER. WE HAVE ALREADY CLEANED THE NEEDLE OURSELVES AND SOAKED IT IN WARM WATER, BUT THE CARRYOVER REMAINS.

Additional Manufacturer Narrative

THE FOLLOWING FIELDS HAVE BEEN CORRECTED: D.4 UNIQUE IDENTIFIER (UDI) #: (B)(4). H.6 IMDRF ANNEX B: B21. H.6 IMDRF ANNEX C: C21. H.6 IMDRF ANNEX D: D16.

Description of Event or Problem

IT WAS REPORTED THAT DURING USE WITH BD FACS¿ LYSE WASH ASSISTANT CARRYOVER OF PATIENT SAMPLE OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM DUTCH TO ENGLISH: WITH THIS LYSIS WASH WE SEE QUITE A LOT OF CARRY OVER. WE HAVE ALREADY CLEANED THE NEEDLE OURSELVES AND SOAKED IT IN WARM WATER, BUT THE CARRYOVER REMAINS.

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: THE CUSTOMER REPORTED A COMPLAINT REGARDING CONTAMINATION. BASED ON THE INVESTIGATION RESULTS, COMPLAINT WAS CONFIRMED, AND THE POTENTIAL CAUSE WAS A DIRTY CELL WASH ASSEMBLY. INVESTIGATION RESULTS THAT WERE PERFORMED ON THE INDICATED FAILURE MODE WERE THE FOLLOWING : THE CUSTOMER REPORTED A COMPLAINT REGARDING CARRYOVER. IN (B)(4) THE FIELD SERVICE REPRESENTATIVE (FSR), INSPECTED THE INSTRUMENT. THEY DISASSEMBLED THE CELL WASH FOR INSPECTION. THE INNER TUBES WERE VERY DIRTY. THE FSR PERFORMED PREVENTIVE MAINTENANCE (PM) IN (B)(4). DURING THE PM, PARTS WERE REPLACED, AND THE CAROUSEL WAS RUN WITH TEST TUBES. THE ISSUE WAS RESOLVED AFTER THE PM. ALTHOUGH THE INSTRUMENT WAS USED FOR DIAGNOSTIC TESTING, THERE WERE NO ERRONEOUS RESULTS. THE ISSUE WAS IDENTIFIED AND RESOLVED BEFORE THE PATIENT SAMPLE RESULTS WERE USED FOR ANY DIAGNOSIS OR TREATMENT. NEITHER THE CUSTOMER NOR ANY PATIENTS WERE HARMED DUE TO THIS ISSUE. COMPLAINTS RECEIVED FOR THIS DEVICE AND REPORTED CONDITION WILL CONTINUE TO BE TRACKED AND TRENDED. INFORMATION WILL BE CAPTURED ON TREND REPORTS AND MONITORED. OUR BUSINESS TEAM REGULARLY REVIEWS THE COLLECTED DATA FOR IDENTIFICATION OF EMERGING TRENDS.

Description of Event or Problem

IT WAS REPORTED THAT DURING USE WITH BD FACS¿ LYSE WASH ASSISTANT CARRYOVER OF PATIENT SAMPLE OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM DUTCH TO ENGLISH: WITH THIS LYSIS WASH WE SEE QUITE A LOT OF CARRY OVER. WE HAVE ALREADY CLEANED THE NEEDLE OURSELVES AND SOAKED IT IN WARM WATER, BUT THE CARRYOVER REMAINS.