BD FACS¿ LWA
Report
- Report Number
- 2916837-2023-00063
- Event Type
- Injury
- Date Received
- March 7, 2023
- Date of Event
- March 1, 2023
- Report Date
- August 1, 2023
- Manufacturer
- BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES
- Product Code
- JQW
- PMA / PMN Number
- EXEMPT
- Adverse Event
- Yes
- Product Problem
- Yes
- Report Source
- Manufacturer report
- Reporter Location
- NE, US
- Reporter Occupation
- OTHER HEALTH CARE PROFESSIONAL
- Health Professional
- Yes
Narratives
H.6: ¿ SCOPE OF ISSUE: THE SCOPE OF ISSUE IS ONLY LIMITED TO LWA INCLUDING EXTERNAL TANK OPTION, PART # 337408 AND SERIAL # (B)(6). ¿ PROBLEM STATEMENT: CUSTOMER REPORTED COMPLAINT REGARDING CARRYOVER ON 01MAR2023. THIS POSES THE RISK OF PRODUCING DELAYED OR ERRONEOUS RESULTS THAT MIGHT IMPACT PATIENT DIAGNOSIS AND TREATMENT. ERRONEOUS RESULTS WERE OBTAINED AND REPORTED TO THE CLINICIAN. THE FALSE POSITIVE FROM THE INSTRUMENT RESULTED IN PERFORMING AN UNNECESSARY BONE MARROW DRAW FROM THE PATIENT. HOWEVER, THIS DID NOT AFFECT PATIENT TREATMENT AND THERE WAS NO ACTUAL HARM OR INJURY TO THE PATIENT. THE INSTRUMENT WAS REPAIRED AND FOUND TO BE FUNCTIONING AS EXPECTED. ¿ MANUFACTURING DEFECT TREND: THERE ARE ZERO QNS (QUALITY NOTIFICATIONS) RELATED TO THE REPORTED ISSUE FOR PART # 337408. DATE RANGE FROM 01MAR2022 TO 01MAR2023. ¿ DEVICE HISTORY RECORD (DHR) REVIEW: DHR PART # 337408 SERIAL # (B)(6) , FILE # 337146-337146-R337146000962-106695823-20, WAS REVIEWED. THE INSTRUMENT MET ALL THE MANUFACTURING SPECIFICATIONS PRIOR TO RELEASE. INSTRUMENT DATE OF MANUFACTURE: 24MAR2020 ¿ COMPLAINT HISTORY REVIEW: THERE ARE 4 COMPLAINTS FOR PART # 337408 RELATED TO AS REPORTED CODE 1: CONTAMINATION - CARRY OVER; PR 5309001, 7159343, 7307638, AND THIS ONE, PR 7325585. DATE RANGE FROM 01MAR2022 TO 01MAR2023. ¿ RETURNED SAMPLE ANALYSIS: A RETURN SAMPLE EVALUATION WAS NOT REQUESTED BECAUSE THE PART REPLACED IS NOT RETURNABLE AND WAS DISCARDED. ¿ SERVICE HISTORY REVIEW: REVIEW OF RELATED WORK ORDER #: 02882755, 02884391; CASE # 01948133 INSTALL DATE: 02APR2020 DEFECTIVE PART NUMBER: 342619 WORK ORDER NOTES: WO-02884391 O SUBJECT / REPORTED: CARRYOVER ISSUE O PROBLEM DESCRIPTION: CARRYOVER ISSUE O WORK PERFORMED: ¿ ARRIVED ON SITE TO COMPLETE A REPAIR ON SERIAL NUMBER R337146000962 LOCATED AT NEBRASKA MEDICAL CENTER IN OMAHA, NE. I COMPLETED THE REPAIR AS PER LWA SERVICE MANUAL DOC. NUMBER 335322. O CAUSE: SEMI CLOGGED RESTRICTOR O SOLUTION: ¿ THE INSTRUMENT IS TESTING WITHOUT ERRORS AND I HAVE RETURNED THE INSTRUMENT TO THE LAB FOR NORMAL USE, UNIT IS OPERATIONAL. ¿ VERIFIED UNIT¿S PERFORMANCE DUE TO CARRYOVER ISSUES. TEST RESULTS ARE WITHIN BD SPECS. THE ONLY FINDING WAS THAT THE RESTRICTOR IN THE SPINDLE CLEANSE TUBING WAS SEMI CLOGGED. SPINDLE CLEANSE SOLUTION WAS STILL GETTING TO THE SPINDLE BUT NOT AS MUCH AS WITH A NEW RESTRICTOR. A NEW RESTRICTOR WAS INSTALLED P/N 342619, NON-STOCK ITEM. UNIT WAS LEFT WORKING PROPERLY. O PARTS REPLACED: 342619 ¿ LABELING / PACKAGING REVIEW: N/A ¿ RISK ANALYSIS: RISK MANAGEMENT FILE PART # 10000597659, REV. 03/VERS. C, RA BD FACS LYSE WASH ASSISTANT WAS REVIEWED. NO NEW HAZARDS HAVE BEEN IDENTIFIED AND THE CURRENT MITIGATION IS SUFFICIENT. HAZARD(S) IDENTIFIED? ¿YES ¿NO O ID: 3.1.1 O HAZARD: CARRYOVER O CAUSE: DIRTY SPINDLE O HARMFUL EFFECTS: INACCURATE RESULTS O RESIDUAL PROBABILITY: 1 O RESIDUAL SEVERITY: 3 O RESIDUAL RISK INDEX: 3 ¿ POTENTIAL CAUSES: IN THE FIELD SERVICE VISIT AFTER THE OCCURRENCE OF CARRYOVER, THE FSE IDENTIFIED A SEMI-CLOGGED RESTRICTOR AND REPLACED IT. HOWEVER, THE POTENTIAL CAUSE CANNOT BE DETERMINED. ¿ INVESTIGATION RESULT / ANALYSIS: THE INVESTIGATION WAS PERFORMED AND BASED ON THE REVIEW OF COMPLAINT TREND, DEFECT TREND, DHR REVIEW, RISK ANALYSIS, SERVICE ACTIVITY REVIEW, AND ADDITIONAL CARRYOVER PROTOCOL TEST, THE POTENTIAL CAUSE OF THE CARRYOVER COULD NOT BE DETERMINED. THE CUSTOMER REPORTED A COMPLAINT REGARDING CARRYOVER. THE CUSTOMER REPORTED THAT THE PREVIOUS TUBES OF POSITIVE LEUKEMIA PATIENT CARRIED OVER TO ANOTHER PATIENT TUBE WHICH CAUSED A FALSE POSITIVE READING AND AN UNNECESSARY BONE MARROW DRAW. ALTHOUGH THE PATIENT HAD TO GO THROUGH AN ADDITIONAL TEST AS A RESULT OF THE FALSE POSITIVE, THERE WAS NO ACTUAL HARM OR INJURY TO THE PATIENT. THE CUSTOMER REPORTED THAT THEY HAVE SELF-IDENTIFIED A WORK-AROUND FOR THE REPORTED ISSUE IN ORDER TO CONTINUE RUNNING THEIR LABORATORY DEVELOPED TEST (LDT). IN WO-02884391, THE FIELD SERVICE ENGINEER (FSE) VISITED THE SITE TO INSPECT AND REPAIR THE INSTRUMENT. THE FSE IDENTIFIED A SEMI-CLOGGED RESTRICTOR, BUT IT CANNOT BE CONFIRMED THAT THIS WAS THE CAUSE OF THE CARRYOVER. THEY FOUND THAT THE RESTRICTOR IN THE SPINDLE CLEANSE TUBING WAS SEMI CLOGGED AND INSTALLED A NEW RESTRICTOR (PN 342619). THE INSTRUMENT WAS TESTED, AND IT WAS VERIFIED THAT IT WAS FUNCTIONING ACCORDING TO SPECIFICATIONS. IN ADDITION TO THE FSE VISIT, A CARRYOVER PROTOCOL TEST WAS PERFORMED ON THIS INSTRUMENT ON 14MAR2023 PER SB LWA-20-61_REV01. THE INSTRUMENT PASSED THE TEST AND DID NOT EXHIBIT CARRYOVER. PROPER DAILY AND MONTHLY CLEANING PROCEDURES CAN BE FOUND UNDER ¿MAINTENANCE¿ IN THE USER GUIDE; BD FACS¿ LYSE WASH ASSISTANT INSTRUCTIONS FOR USE, #23-11113 REV. 02/VERS. A, STARTING PAGE 107. ¿ CONCLUSION: BASED ON THE INVESTIGATION RESULTS, THE CUSTOMER REPORTED A COMPLAINT REGARDING CARRYOVER BUT A SPECIFIC CAUSE FOR THE CUSTOMER¿S COMPLAINT COULD NOT BE CONFIRMED. IN THE FIELD SERVICE VISIT AFTER THE OCCURRENCE OF CARRYOVER, THE FSE IDENTIFIED A SEMI-CLOGGED RESTRICTOR AND REPLACED IT. HOWEVER, SINCE THE CAUSE OF CARRYOVER COULD NOT BE ATTRIBUTED TO INSTRUMENT FAILURE, A CAPA/SA/SCAR IS NOT REQUIRED. IN ADDITION, A CARRYOVER PROTOCOL TEST THAT WAS PERFORMED ON THE INSTRUMENT REVEALED NO EVIDENCE OF CARRYOVER OUTSIDE OF ACCEPTED LEVELS. THE PATIENT HAD TO GO THROUGH AN ADDITIONAL TEST AS A RESULT OF THE FALSE POSITIVE. HOWEVER, THERE WAS NO ACTUAL HARM OR INJURY TO THE PATIENT. THE INSTRUMENT WAS REPAIRED AND WAS FOUND TO BE PERFORMING PER SPECIFICATION.
PATIENT 1 OF 3. THE FOLLOWING FIELDS HAVE BEEN UPDATED WITH CORRECTED AND/OR ADDITIONAL INFORMATION. D.9 - REMOVAL OF SERIAL NUMBER AS IT COULD BE ONE OF TWO INSTRUMENTS: SN# (B)(6) SN# (B)(6).
INITIAL REPORTER ADDRESS 1: (B)(6). A DEVICE EVALUATION IS ANTICIPATED, BUT HAS NOT YET BEGUN. UPON COMPLETION OF THE INVESTIGATION, A SUPPLEMENTAL REPORT WILL BE FILED.
IT WAS REPORTED THAT WHILE USING BD FACS¿ LWA CARRYOVER BETWEEN PATIENT SAMPLES HAD OCCURRED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: RECEIVED THE FOLLOWING ADDITIONAL INFORMATION FROM THE INITIAL REPORTER. THE INITIAL MDR STATED THAT THE ISSUE CAUSED A FALSE POSITIVE READING AND AN UNNECESSARY BONE MARROW DRAW FROM 2 OR MORE PATIENTS. THE CUSTOMER HAS NOW CONFIRMED THAT ONLY 1 UNNECESSARY BONE MARROW DRAW FROM 1 PATIENT WAS RELATED TO THE REPORTED EVENT. RECEIVED CONFIRMATION EMAIL 22MAY2023 HOW MANY PATIENTS REALLY HAD UNNECESSARY BONE MARROW EXTRACTS DUE TO INCORRECT RESULTS FROM LWAS? STEVE K'S NOTE INDICATE 2 OR MORE. NEED TO CONFIRM FOR CERTAIN. THE CARRYOVER EVENTS OCCURRED THREE TIMES. ONLY ONE RESULTED IN A BM ASPIRATE BEING ORDERED. THE SECOND AND THIRD TIME WERE CAUGHT BEFORE A PATIENT WAS AFFECTED. CUSTOMER REPORTS PREVIOUS TUBES OF POSITIVE LEUKEMIA PATIENT CARRIED OVER TO ANOTHER PATIENT TUBE. THIS CAUSED A FALSE POSITIVE READING AND AN UNNECESSARY BONE MARROW DRAW FROM 2 OR MORE PATIENTS. CUSTOMER COULD PROVIDE NO PATIENT DETAILS DUE TO HIPA RESTRICTIONS. IF THEY RUN AN LEUKEMIA SAMPLE THAT IS HIGH IN BLASTS THE FOLLOWING SAMPLE WILL BE CONTAMINATED WITH THE LEUKEMIC SAMPLE. THIS HAS HAPPENED TWICE AND AFFECTED PATIENT RESULTS. IF THEY RUN A WATER TUBE BETWEEN SAMPLES THERE WILL BE NO CONTAMINATION. ANY SAMPLE THAT HAS A KNOWN WHITE BLOOD CELL COUNT ABOUT 50,000 (UNITS UNKNOWN), CUSTOMER IS USING THE WORK AROUND DESCRIBED TO PREVENT CARRYOVER. WORKAROUND FOR ISSUE IS TO RUN ONE OR MORE TUBES OF DI WATER AS A PATIENT SAMPLE BETWEEN ACTUAL PATIENT SAMPLES TO PREVENT CARRYOVER. HAZARD, INJURY OR ERRONEOUS RESULTS? YES HAZARD, INJURY OR ERRONEOUS RESULTS DETAILS FALSE POSITIVE FROM INSTRUMENT RESULTED IN UNNECESSARY BONE MARROW DRAW ON PATIENTS WERE SAMPLES CONTAMINATED? YES ARE THERE ERRONEOUS RESULTS ON PATIENT SAMPLES FROM DIAGNOSTIC TEST? YES WAS THERE ANY DELAY OF TREATMENT DUE TO THE ISSUE? NO IF PATIENT SAMPLES WERE REDRAWN, WAS THERE ANY CHANGE OR DELAY OF TREATMENT? NO WAS THERE ANY PHYSICAL HARM/INJURY TO THE PATIENT DUE TO THE ISSUE? NO PROVIDE DETAILS- HOW AND TO WHAT EXTENT? THERE WAS UNNECESSARY BONE MARROW DRAW FROM THE PATIENT DUE TO FALSE POSITIVE READING FROM LWA.
IT WAS REPORTED THAT WHILE USING BD FACS¿ LWA CARRYOVER BETWEEN PATIENT SAMPLES HAD OCCURRED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THAT THEY ARE HAVING CARRYOVER ISSUES. CUSTOMER REPORTS PREVIOUS TUBES OF POSITIVE LEUKEMIA PATIENT CARRIED OVER TO ANOTHER PATIENT TUBE. THIS CAUSED A FALSE POSITIVE READING AND AN UNNECESSARY BONE MARROW DRAW FROM 2 OR MORE PATIENTS. CUSTOMER COULD PROVIDE NO PATIENT DETAILS DUE TO HIPA RESTRICTIONS. IF THEY RUN AN LEUKEMIA SAMPLE THAT IS HIGH IN BLASTS THE FOLLOWING SAMPLE WILL BE CONTAMINATED WITH THE LEUKEMIC SAMPLE. THIS HAS HAPPENED TWICE AND AFFECTED PATIENT RESULTS. IF THEY RUN A WATER TUBE BETWEEN SAMPLES THERE WILL BE NO CONTAMINATION. ANY SAMPLE THAT HAS A KNOWN WHITE BLOOD CELL COUNT ABOUT 50,000 (UNITS UNKNOWN), CUSTOMER IS USING THE WORK AROUND DESCRIBED TO PREVENT CARRYOVER. WORKAROUND FOR ISSUE IS TO RUN ONE OR MORE TUBES OF DI WATER AS A PATIENT SAMPLE BETWEEN ACTUAL PATIENT SAMPLES TO PREVENT CARRYOVER. 1ST PATIENT AFFECTED ¿ WAS DIAGNOSED WITH ACUTE LEUKEMIA, ADMITTED TO HOSPITAL OVERNIGHT, HAD BM TESTED. BM TEST WAS NEGATIVE. 2ND PATIENT AFFECTED ¿ RESULTS WENT TO PHYSICIAN BUT WERE NOT RELAYED TO PATIENT, SHE THINKS IT WAS RE-TESTED AS NEG. 3RD PATIENT AFFECTED ¿ LAB PATHOLOGIST CAUGHT IT BEFORE BEING RELEASED. HAZARD, INJURY OR ERRONEOUS RESULTS? YES. HAZARD, INJURY OR ERRONEOUS RESULTS DETAILS FALSE POSITIVE FROM INSTRUMENT RESULTED IN UNNECESSARY BONE MARROW DRAW ON PATIENTS. WERE SAMPLES CONTAMINATED? YES. ARE THERE ERRONEOUS RESULTS ON PATIENT SAMPLES FROM DIAGNOSTIC TEST? YES. WAS THERE ANY DELAY OF TREATMENT DUE TO THE ISSUE? NO. IF PATIENT SAMPLES WERE REDRAWN, WAS THERE ANY CHANGE OR DELAY OF TREATMENT? NO. WAS THERE ANY PHYSICAL HARM/INJURY TO THE PATIENT DUE TO THE ISSUE? NO. PROVIDE DETAILS- HOW AND TO WHAT EXTENT? THERE WAS UNNECESSARY BONE MARROW DRAW FROM THE PATIENT DUE TO FALSE POSITIVE READING FROM LWA.
IT WAS REPORTED THAT WHILE USING BD FACS¿ LWA CARRYOVER BETWEEN PATIENT SAMPLES HAD OCCURRED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: RECEIVED THE FOLLOWING ADDITIONAL INFORMATION FROM THE INITIAL REPORTER. THE INITIAL MDR STATED THAT THE ISSUE CAUSED A FALSE POSITIVE READING AND AN UNNECESSARY BONE MARROW DRAW FROM 2 OR MORE PATIENTS. THE CUSTOMER HAS NOW CONFIRMED THAT ONLY 1 UNNECESSARY BONE MARROW DRAW FROM 1 PATIENT WAS RELATED TO THE REPORTED EVENT. RECEIVED CONFIRMATION EMAIL 22MAY2023 . HOW MANY PATIENTS REALLY HAD UNNECESSARY BONE MARROW EXTRACTS DUE TO INCORRECT RESULTS FROM LWAS? STEVE K'S NOTE INDICATE 2 OR MORE. NEED TO CONFIRM FOR CERTAIN. THE CARRYOVER EVENTS OCCURRED THREE TIMES. ONLY ONE RESULTED IN A BM ASPIRATE BEING ORDERED. THE SECOND AND THIRD TIME WERE CAUGHT BEFORE A PATIENT WAS AFFECTED. CUSTOMER REPORTS PREVIOUS TUBES OF POSITIVE LEUKEMIA PATIENT CARRIED OVER TO ANOTHER PATIENT TUBE. THIS CAUSED A FALSE POSITIVE READING AND AN UNNECESSARY BONE MARROW DRAW FROM 2 OR MORE PATIENTS. CUSTOMER COULD PROVIDE NO PATIENT DETAILS DUE TO HIPA RESTRICTIONS. IF THEY RUN AN LEUKEMIA SAMPLE THAT IS HIGH IN BLASTS THE FOLLOWING SAMPLE WILL BE CONTAMINATED WITH THE LEUKEMIC SAMPLE. THIS HAS HAPPENED TWICE AND AFFECTED PATIENT RESULTS. IF THEY RUN A WATER TUBE BETWEEN SAMPLES THERE WILL BE NO CONTAMINATION. ANY SAMPLE THAT HAS A KNOWN WHITE BLOOD CELL COUNT ABOUT 50,000 (UNITS UNKNOWN), CUSTOMER IS USING THE WORK AROUND DESCRIBED TO PREVENT CARRYOVER. WORKAROUND FOR ISSUE IS TO RUN ONE OR MORE TUBES OF DI WATER AS A PATIENT SAMPLE BETWEEN ACTUAL PATIENT SAMPLES TO PREVENT CARRYOVER. HAZARD, INJURY OR ERRONEOUS RESULTS? YES. HAZARD, INJURY OR ERRONEOUS RESULTS DETAILS FALSE POSITIVE FROM INSTRUMENT RESULTED IN UNNECESSARY BONE MARROW DRAW ON PATIENTS WERE SAMPLES CONTAMINATED? YES. ARE THERE ERRONEOUS RESULTS ON PATIENT SAMPLES FROM DIAGNOSTIC TEST? YES. WAS THERE ANY DELAY OF TREATMENT DUE TO THE ISSUE? NO. IF PATIENT SAMPLES WERE REDRAWN, WAS THERE ANY CHANGE OR DELAY OF TREATMENT? NO. WAS THERE ANY PHYSICAL HARM/INJURY TO THE PATIENT DUE TO THE ISSUE? NO. PROVIDE DETAILS- HOW AND TO WHAT EXTENT? THERE WAS UNNECESSARY BONE MARROW DRAW FROM THE PATIENT DUE TO FALSE POSITIVE READING FROM LWA.
IT WAS REPORTED THAT WHILE USING BD FACS¿ LWA CARRYOVER BETWEEN PATIENT SAMPLES HAD OCCURRED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THAT THEY ARE HAVING CARRYOVER ISSUES. CUSTOMER REPORTS PREVIOUS TUBES OF POSITIVE LEUKEMIA PATIENT CARRIED OVER TO ANOTHER PATIENT TUBE. THIS CAUSED A FALSE POSITIVE READING AND AN UNNECESSARY BONE MARROW DRAW FROM 2 OR MORE PATIENTS. CUSTOMER COULD PROVIDE NO PATIENT DETAILS DUE TO HIPA RESTRICTIONS. IF THEY RUN AN LEUKEMIA SAMPLE THAT IS HIGH IN BLASTS THE FOLLOWING SAMPLE WILL BE CONTAMINATED WITH THE LEUKEMIC SAMPLE. THIS HAS HAPPENED TWICE AND AFFECTED PATIENT RESULTS. IF THEY RUN A WATER TUBE BETWEEN SAMPLES THERE WILL BE NO CONTAMINATION. ANY SAMPLE THAT HAS A KNOWN WHITE BLOOD CELL COUNT ABOUT 50,000 (UNITS UNKNOWN), CUSTOMER IS USING THE WORK AROUND DESCRIBED TO PREVENT CARRYOVER. WORKAROUND FOR ISSUE IS TO RUN ONE OR MORE TUBES OF DI WATER AS A PATIENT SAMPLE BETWEEN ACTUAL PATIENT SAMPLES TO PREVENT CARRYOVER. 1ST PATIENT AFFECTED ¿ WAS DIAGNOSED WITH ACUTE LEUKEMIA, ADMITTED TO HOSPITAL OVERNIGHT, HAD BM TESTED. BM TEST WAS NEGATIVE. 2ND PATIENT AFFECTED ¿ RESULTS WENT TO PHYSICIAN BUT WERE NOT RELAYED TO PATIENT, SHE THINKS IT WAS RE-TESTED AS NEG. 3RD PATIENT AFFECTED ¿ LAB PATHOLOGIST CAUGHT IT BEFORE BEING RELEASED. HAZARD, INJURY OR ERRONEOUS RESULTS? YES. HAZARD, INJURY OR ERRONEOUS RESULTS DETAILS FALSE POSITIVE FROM INSTRUMENT RESULTED IN UNNECESSARY BONE MARROW DRAW ON PATIENTS. WERE SAMPLES CONTAMINATED? YES. ARE THERE ERRONEOUS RESULTS ON PATIENT SAMPLES FROM DIAGNOSTIC TEST? YES. WAS THERE ANY DELAY OF TREATMENT DUE TO THE ISSUE? NO. IF PATIENT SAMPLES WERE REDRAWN, WAS THERE ANY CHANGE OR DELAY OF TREATMENT? NO. WAS THERE ANY PHYSICAL HARM/INJURY TO THE PATIENT DUE TO THE ISSUE? NO. PROVIDE DETAILS- HOW AND TO WHAT EXTENT? THERE WAS UNNECESSARY BONE MARROW DRAW FROM THE PATIENT DUE TO FALSE POSITIVE READING FROM LWA.
Devices
| Seq | Brand | Generic | Product Code | Manufacturer | Model | Lot | UDI-DI |
|---|---|---|---|---|---|---|---|
| 659158 | BD FACS¿ LWA | STATION, PIPETTING DILUTING CLINICAL USE | JQW | BECTON, DICKINSON AND COMPANY, BD BIOSCIENCES |
Patients
| Seq | Age | Sex | Outcome | Treatment |
|---|---|---|---|---|
| 1 | Unknown | Required Intervention| H |