BD FACS¿ LYSE WASH ASSISTANT
Received May 22, 2024 · Event occurred Apr 23, 2024
Report 2916837-2024-00032 · MDR key 19375799
Device
Generic name
Station, Pipetting Diluting Clinical Use
Manufacturer
Becton Dickinson And Company Bd BiosciencesCatalog number
337146
Product problems
- Incorrect, Inadequate or Imprecise Result or Readings
- Incorrect, Inadequate or Imprecise Result or Readings
Patient
NA · Unknown
- No Clinical Signs, Symptoms or Conditions
- No Clinical Signs, Symptoms or Conditions
Narrative
Additional Manufacturer Narrative
THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTED INFORMATION: D.4. MEDICAL DEVICE SERIAL #: (B)(6). D.4. UNIQUE IDENTIFIER (UDI) #:(B)(4). H.4. DEVICE MANUFACTURE DATE: 12-MAY-2023. 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 WHILE USING BD LYSE WASH ASSISTANT EXPERIENCES CARRYOVER ISSUES. THERE WAS NO REPORT OF USER IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM GERMAN TO ENGLISH: "WE GENERALLY OBSERVE THAT CELLS ARE OCCASIONALLY CARRIED OVER INTO THE LWAS."
Additional Manufacturer Narrative
BASED ON THE INVESTIGATION RESULTS, THE REPORTED ISSUE OF CARRYOVER DUE TO SAMPLE SPLATTER ON THE CAROUSEL RACK WAS NOT CONFIRMED. THE POTENTIAL CAUSE COULD NOT BE DETERMINED. THE FSE PERFORMED A SERIES OF TESTS ON THE INSTRUMENT AND COULD NOT REPRODUCE THE ERROR OR CONFIRM THE CARRYOVER ISSUE, AND THE INSTRUMENT WAS RETURNED TO OPERATIONAL STATUS. THIS ISSUE DID NOT IMPACT PATIENT DIAGNOSIS OR TREATMENT AND NO USER OR PATIENT WAS HARMED OR INJURED. THE COMPLAINT SAMPLE WAS NOT REQUESTED TO BE RETURNED BECAUSE NO PARTS WERE REPLACED. REVIEW OF THE DHR CONFIRMED THAT THE INSTRUMENT MET ALL THE MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE.
Description of Event or Problem
IT WAS REPORTED THAT WHILE USING BD LYSE WASH ASSISTANT EXPERIENCES CARRYOVER ISSUES. THERE WAS NO REPORT OF USER IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM GERMAN TO ENGLISH: "WE GENERALLY OBSERVE THAT CELLS ARE OCCASIONALLY CARRIED OVER INTO THE LWAS."
Additional Manufacturer Narrative
DATE OF EVENT: UNKNOWN. THE DATE RECEIVED BY MANUFACTURER HAS BEEN USED FOR THIS FIELD. INITIAL REPORTER PHONE #: (B)(6). PMA / 510(K)#: THIS DEVICE IS CURRENTLY LISTED AS EXEMPT FOR 510K. A DEVICE EVALUATION AND/OR DEVICE HISTORY REVIEW IS ANTICIPATED BUT IS NOT COMPLETE. UPON COMPLETION, A SUPPLEMENTAL REPORT WILL BE FILED. DEVICE MANUFACTURE DATE: UNKNOWN.
Description of Event or Problem
IT WAS REPORTED THAT WHILE USING BD LYSE WASH ASSISTANT EXPERIENCES CARRYOVER ISSUES. THERE WAS NO REPORT OF USER IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM GERMAN TO ENGLISH: "WE GENERALLY OBSERVE THAT CELLS ARE OCCASIONALLY CARRIED OVER INTO THE LWAS."