FACSCanto 657338Recalls & reported problems

Summary

The FDA's MAUDE database contains 46 adverse event reports that list this exact device (DI 00382906573384), received between Feb 28, 2019 and Jul 3, 2025 — classified as 4 injuries, 42 malfunctions.

The most frequently reported specific device problem is “Incorrect, Inadequate or Imprecise Result or Readings” (21 reports).

Reports come from manufacturers, hospitals and patients and are not verified by the FDA. A report does not prove the device caused the event, and counts can't be used to compare devices or estimate failure rates. How this data works · Data updated Oct 13, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 46 reports, in the reporter's own words as published by the FDA.

• MalfunctionJul 3, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE USING BD FACSCANTO¿ FLOW CYTOMETER PRODUCED ERRONEOUS FINAL LABORATORY RESULT FROM THE BD PRODUCT THAT WAS REPORTED TO A CLINICIAN. THERE WAS NO REPORT OF USER IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "FACSCANTO PLUS-UNSATISFACTORY SAMPLE RESULTS USING PATIENT SAMPLES, NOT SURE IF IT CAUSES HARM." MDR SAFETY CHECKLIST FOR PATIENT SAMPLES. 1. DID THIS CAUSE ERRONEOUS RESULTS ON PATIENT SAMPLES FOR DIAGNOSTIC TESTING? IF YES, GO TO QUESTION #2. IF NO, NO FURTHER QUESTIONS REQUIRED. - YES. 2. WAS AN ERRONEOUS LABORATORY RESULT FROM THE BDB PRODUCT REPORTED TO A CLINICIAN? IF YES, GO TO QUESTION #3. IF NO, NO FURTHER QUESTIONS REQUIRED. - YES. MDR SAFETY CHECKLIST FOR CONTAMINATION. 1. WERE PATIENT SAMPLES CONTAMINATED OR WAS THERE CARRYOVER (CROSS-CONTAMINATION/MIXING) BETWEEN PATIENT SAMPLES? IF NO, NO FURTHER QUESTIONS REQUIRED. PATIENT SAMPLES CONTAMINATED, CARRYOVER BETWEEN PATIENT SAMPLES, UNKNOWN - GO TO QUESTION #2.: NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22399354 ↗
• MalfunctionMar 19, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING USE WITH FACSCANTO¿ 10-COLOR CONFIGURATION CARRY OVER OCCURRED. THE ISSUE WAS DISCOVERED IN THE LAB AND ERRONEOUS RESULTS WERE NOT REPORTED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CX (FLOW CYTOMETRY MANAGER) REPORTED A SPINAL FLUID SAMPLE THEY RAN BECAME CONTAMINATED. THE SYSTEM OPERATOR DID NOT USE THE "REMOVE TUBE" COMMAND AND POSSIBLE DID NOT FULLY SWING THE ASPIRATOR TO THE LEFT TO INITIATE A SIP CLEANING CYCLE AFTER REMOVING THE PRECEDING SAMPLE. THE SYSTEM DID NOT SUFFICIENTLY CLEAN THE SYSTEM SAMPLE PROBE BEFORE RUNNING THE SPINAL FLUID. THE LAB HAS IMPLEMENTED ADDITIONAL STAFF TRAINING TO PREVENT A RE-OCCURRENCE. THE SPINAL FLUID SAMPLE APPEARED TO INDICATE A POSITIVE LEUKEMIA. INTERNAL LAB PROCEDURES AND CROSS CHECKING CAUGHT THE ISSUE BEFORE RESULTS WERE REPORTED. MDR SAFETY CHECKLIST -- CONTAMINATION: 1. WERE SAMPLES CONTAMINATED? YES. 1. ARE THERE ERRONEOUS RESULTS ON PATIENT SAMPLES FROM DIAGNOSTIC TEST? (IF YES OR UNKNOWN, GO TO QUESTION #2. IF NO, NO FURTHER QUESTIONS REQUIRED.): YES. 2. WAS THERE ANY DELAY OF TREATMENT DUE TO THE ISSUE? UNKNOWN. 3. IF PATIENT SAMPLES WERE RED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18933620 ↗
• MalfunctionJan 10, 2024Improper or Incorrect Procedure or Method; Improper or Incorrect Procedure or Method

  IT WAS REPORTED THAT WHILE USING BD FACSCANTO¿, ERRONEOUS RESULTS WERE ACQUIRED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY CUSTOMER THAT POPULATIONS ARE NOT CORRECT. PATIENT SAMPLES CHECKLIST SUMMARY: 1. ARE THERE ERRONEOUS RESULTS ON PATIENT SAMPLES FROM DIAGNOSTIC TEST? (IF YES OR UNKNOWN, GO TO QUESTION #2. IF NO, NO FURTHER QUESTIONS REQUIRED.): YES. 2. WAS THERE ANY DELAY OF TREATMENT DUE TO THE ISSUE? (GO TO QUESTION #3): NO. 3. IF PATIENT SAMPLES WERE REDRAWN, WAS THERE ANY CHANGE OR DELAY OF TREATMENT? (GO TO QUESTION #4): NOT APPLICABLE. 4. WAS THERE ANY PHYSICAL HARM/INJURY TO THE PATIENT DUE TO THE ISSUE? (IF YES OR UNKNOWN, GO TO QUESTION # NO. 5. IF NO, NO FURTHER QUESTIONS REQUIRED): 5. PROVIDE DETAILS - HOW AND TO WHAT EXTENT? (GO TO QUESTION #6): CONTAMINATION: 1.WERE SAMPLES CONTAMINATED?(IF NO, NO FURTHER QUESTIONS REQUIRED. IF YES, OR UNKNOWN GO TO PATIENT SAMPLE CHECKLIST): NO. YES. LEAK CHECKLIST SUMMARY: 1. DID ANY LIQUID LEAKAGE OR SPLASH OR SPRAY COME INTO CONTACT WITH EYES OR MOUTH OR ANY MUCOUS MEMBRANE OR NON-INTACT(BROKEN) SKIN? IF NO, STOP- NO FURTHER QUESTIONS REQUIRED: NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18486914 ↗
• MalfunctionOct 11, 2023Use of Device Problem; Use of Device Problem

  IT WAS REPORTED THAT ERROR MESSAGES WERE BYPASSED AND TESTING WAS STILL ABLE TO CONTINUE DURING USE WITH THE BD FACSCANTO¿. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WE HAVE AN ERROR WINDOW POPPING UP ON OUR DIVA SOFTWARE AFTER THE END OF CERTAIN PANELS BUT NOT ALL RUNS (LEUKEMIA PANELS, RITUXIMAB PANELS, ETC.) ALSO, OUR SOFTWARE SEEMS TO BE RUNNING SLOW AND HAS TROUBLE ACCESSING EXPORT FOLDER FILES WHEN DOING THE CAROUSEL SETUP. STEPS TAKEN WITH CUSTOMER/TROUBLESHOOTING: SPOKE WITH CUSTOMER AND THEY ARE HAVING ISSUES RUNNING SOME OF THEIR PANELS. SOME PANELS WORK SOME DO NOT. SUSPECT THE PANELS ARE CORRUPT. CUSTOMER WOULD LIKE THE FSE TO LOOK AT IT ADDITIONAL INFORMATION: 1. ARE YOU RUNNING PATIENT SAMPLES FOR DIAGNOSTIC TEST? (IF YES OR UNKNOWN, GO TO QUESTION #2. IF NO, NO FURTHER QUESTIONS REQUIRED.): YES. 2. WAS THERE AN ERROR MESSAGE? (IF YES, GO TO QUESTION #3. IF NO, NO FURTHER QUESTIONS REQUIRED.): YES. 3. DID THE CUSTOMER BYPASS THE ERROR MESSAGE? (IF YES, GO TO QUESTION #4. IF NO, NO FURTHER QUESTIONS REQUIRED.): YES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17916628 ↗
• MalfunctionAug 1, 2023Break; Break

  IT WAS REPORTED THAT THE LOADER COVER WAS BROKEN AND ACCESSED BY THE USER ON THE BD FACSCANTO¿. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE ISSUE WAS RESOLVED VIA MAILED COVER (338709) TO CUSTOMER AND REPLACED BY CUSTOMER THEMSELVES. THE INSTRUMENT RUNS NORMALLY. FACSCANTO PLUS- THE COVER OF LOADER IS BROKEN.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17435392 ↗
• MalfunctionJun 1, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE USING THE BD FACSCANTO¿ THAT THERE WAS CARRYOVER INVOLVING PATIENT SAMPLES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: A USER REPORTED A CARRY OVER ISSUE BETWEEN SAMPLES TO THE SERVICE ENGINEER. THE PROBLEM OCCURS SPORADICALLY. THE CUSTOMER CLAIMS THAT THE RESULTS HAVE NOT BEEN SENT TO TREAT THE PATIENT. THE PROBLEM WAS DETECTED DURING THE ANALYSIS OF THE RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17038967 ↗
• MalfunctionMar 31, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE USING THE BD FACSCANTO¿ THAT THERE WAS ERRONEOUS RESULTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: SERVICEMAX ESB: (B)(6) 2023 11:02:09 (GMT). ABNORMAL SCATTER PLOT OF FACSCANTO PLUS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16660007 ↗
• MalfunctionMar 24, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE USING THE BD FACSCANTO¿ THAT THERE WAS ERRONEOUS RESULTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PATIENT SAMPLE 1. ARE THERE ERRONEOUS RESULTS ON PATIENT SAMPLES FROM DIAGNOSTIC TEST? (IF YES OR UNKNOWN, GO TO QUESTION #2. IF NO, NO FURTHER QUESTIONS REQUIRED.): YES. FACSCANTO PLUS - GRAPH EXCEPTION CLINICAL, USE OF PATIENT SAMPLES, NO POTENTIAL HARM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16607691 ↗
• MalfunctionFeb 8, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE USING THE BD FACSCANTO¿ THAT THERE WAS ERRONEOUS RESULTS.THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER:ABNORMAL GRAPHICS OF FACSCANTO PLUS-B27, CLINICAL USE, THIS RESULT WAS NOT USED, DID NOT AFFECT PATIENT DIAGNOSIS, (B)(6).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16318659 ↗
• MalfunctionNov 17, 2022Break

  IT WAS REPORTED THAT WHILE USING THE BD FACSCANTO¿ THAT THE COUPLING SNAPPED OFF THE WET CART. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: COUPLING SNAPPED OFF WET CART.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15816263 ↗
• MalfunctionNov 16, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT WHILE USING THE BD FACSCANTO¿, THERE WAS LEAKAGE COMING FROM THE SIP. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: INTERMITTENT ISSUE. ONLY WHEN LOADING A TUBE SO THE TUBE ENDS UP WITH MORE FLUID THAN IT BEGINS WITH. FLUID HAS BEEN CONTAINED TO THE TUBE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15811439 ↗
• MalfunctionOct 20, 2022Leak/Splash

  IT WAS REPORTED THAT WHILE USING THE BD FACSCANTO¿ THAT THE CART IS LEAKING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LEAKING FROM THE CART.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15643031 ↗
• MalfunctionOct 17, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE USING THE BD FACSCANTO¿ THAT EXPERIMENTS ARE SHOWING BIMODAL POPULATIONS INCLUDING NEGATIVE POPULATIONS. CST IS PASSING. SYSTEM WAS WORKING JUST FINE AFTER SEPT 19TH SERVICE VISIT. CUSTOMER DOES NOT BELIEVE PATIENTS HAVE BEEN AFFECTED BUT IS REVIEWING PAST EXPERIMENTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER. IT SEEMS THAT THEIR PE VOLTAGE WENT UP SIGNIFICANTLY SINCE A PM IN SEPTEMBER AND THEY ARE SEEING A BIMODAL SIGNAL IN BOTH POSITIVE AND NEGATIVE CLUSTERS. CORRECT COMPENSATION WAS VERIFIED BY THE CUSTOMER. THE PE MFI IS SIMILAR TO PREVIOUS TESTING AT THE LOWER VOLTAGE AND NO OTHER BLUE LASER DETECTORS ARE SHOWING A SIMILAR CHANGE IN VOLTAGE FROM PREVIOUS SETTINGS. CST IS PASSING BECAUSE THE NEW BASELINE HAS BEEN ASSIGNED THE NEW, HIGHER VOLTAGE. PERHAPS THE PE DETECTOR IS GOING OUT? THE CUSTOMER AGAIN REQUESTED A FSE VISIT.... EXPERIMENTS ARE SHOWING BIMODAL POPULATIONS INCLUDING NEGATIVE POPULATIONS. CST IS PASSING. SYSTEM WAS WORKING JUST FINE AFTER SEPT 19TH SERVICE VISIT. CUSTOMER DOES NOT BELIEVE PATIENTS HAVE BEEN AFFECTED BUT IS REVIEWING PAST EXPERIMENTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15614903 ↗
• MalfunctionOct 17, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT WHILE USING FACSCANTO¿ 10-COLOR CONFIGURATION THE WET CART SHOT OUT FLUID. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "WHEN THEY SHUT IT DOWN OVER THE WEEKEND THE WET CART SHOT OUT FLUID. THEY SAID THE FLUID WENT ACROSS THE ROOM AND HIT THE PERSON ACROSS THE ROOM IN THE FEET."

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15614670 ↗
• MalfunctionOct 4, 2022Fluid/Blood Leak; Pressure Problem

  IT WAS REPORTED THAT WHILE USING BD FACSCANTO¿ THAT THERE WAS A WET CAR LEAK. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WET CART LEAK AND TUBE PRESSURIZATION ISSUE WET CART LEAK. FRONT RIGHT CORNER. THE LEAK IS NOT COMING FROM THE FILTERS. LEAK WAS NOT APPARENT FROM BACK DOOR. NO ODOR FROM LEAK. NO ISSUES WHEN RUNNING MANUALLY WET CART LEAK. FRONT RIGHT CORNER. THE LEAK IS NOT COMING FROM THE FILTERS. LEAK WAS NOT APPARENT FROM BACK DOOR.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15536803 ↗
• MalfunctionAug 30, 2022Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING TESTING OF PATIENT SAMPLES WITH BD FACSCANTO¿ ERRONEOUS RESULTS WERE OBTAINED. THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM CHINESE TO ENGLISH: THE TEST RESULT OF THE INSTRUMENT WAS NOT ACCURATE. THE ENGINEER IN THE HOSPITAL ADJUSTED THE INSTRUMENT, THE INSTRUMENT RUNS NORMALLY. USING PATIENT SAMPLES, INACCURATE RESULTS WERE OBTAINED BUT NOT USED, DID NOT AFFECT PATIENT TREATMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15321196 ↗
• MalfunctionJul 20, 2022Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT WHILE USING BD FACSCANTO¿ SPRAY OF SHEATH FLUID COMING FROM THE INSTRUMENT WAS DETECTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "1. WAS THE LEAK LIQUID OR AIR? LIQUID. 2. WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? NOT CONTAINED. 3. (IF NOT CONTAINED) WAS THERE SPRAY OF FLUID UNDER PRESSURE? YES. CUSTOMER STATED THAT THE SHEATH FLUID SPRAYED OUT ONTO THE FLOOR BUT THERE WERE NO INJURIES AS A RESULT OF IT AND IT DID NOT SPRAY ONTO ANYONE. 4. WHAT WAS THE FLUID THAT LEAKED? 5. WHAT IS THE SOURCE OF LEAK ¿ BEFORE WASTE LINE OR AFTER WASTE LINE? -5B (IF WASTE LINE) ¿ WAS WASTE MIXED WITH BLEACH OR DECONTAMINATE? 6. WAS THE CUSTOMER/BD PERSONNEL PHYSICALLY IN CONTACT WITH THE FLUID? 7. WHERE DID THE PHYSICAL CONTACT OF FLUID OCCUR? NO. IT WAS REPORTED BY THE CUSTOMER THAT WETCART LEAKING FROM THE REAR. CUSTOMER STATED THAT THE LEAK WAS COMING FROM THE REAR OF THE WETCART AND HE OPENED THE REAR WHERE HE SAW IT LEAKING FROM AN ORANGE CONNECTOR. AS HE DESCRIPTED THE LEAK IT SOUNDED LIKE IT WAS A BROKEN CONNECTOR FROM THE CHECK VALVE (PN 334044). CUSTOMER STATED THAT NO ONE WAS INJURED AS A RESULT OF THE LEAK AND IT APPEARED TO BE SHEATH FLUID

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15070797 ↗
• MalfunctionJul 6, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT FACSCANTO¿ 10-COLOR CONFIGURATION WAS LEAKING BIOHAZARD THAT WAS NO CONTAINED IN THE INSTRUMENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT?NO, WAS THERE SPRAY OF FLUID UNDER PRESSURE?NO, WHAT WAS THE FLUID THAT LEAKED?BIOHAZARD, WHAT IS THE SOURCE OF LEAK -- WASTE LINE OR NON-WASTE LINE? WASTE LINE, WAS THE LEAK MIXED WITH BLEACH OR DECONTAMINATE?NO, WAS THE CUSTOMER EXPOSED TO BLOOD OR BODILY FLUIDS?NO, WAS THERE ANY PHYSICAL HARM TO THE CUSTOMER AS A RESULT OF THE LEAK?NO. KIYOKAZU MIURA : (B)(6)06:32:26 (GMT). LEAKAGE FROM WETCART INTERNAL VALVE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14940271 ↗
• MalfunctionJun 9, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT WHILE USING BD FACSCANTO¿ LEAKAGE OF BIOHAZARD COMING FROM THE INSTRUMENT WAS DETECTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "DURING THE CLEANING AN ERROR MESSAGE POPS UP. IT LOOKS LIKE THE ASPIRATOR ARM IS NOT ACQUIRING THE LIQUID. THE TUBE IS GETTING WET ON THE TOP. ERROR MESSAGE: VACUUM ERROR HAS BEEN DETECTED. DISCONNECTING AND CONNECTING THE WASTE TANK. STARTUP HAS BEEN PERFORMED AND IT WAS OK. REMOVING THE O-RING AND THE RETAINER, CLEANING AROUND AND MAKING SURE THAT THEY ARE WELL SET DIDN'T HELP NEITHER. THEY DIDN'T USE THE INSTRUMENT FOR MORE THAN TWO WEEKS. MAYBE THE WASTE LINE IS CLOGGED. THERE IS NO LEAK IN THIS WORK ORDER. IF THIS IS ABOUT ¿THE TUBE IS GETTING WET ON THE TOP". IS THE LEAK FLUID OR AIR? FLUID. WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? NO. WAS THE FLUID ACTIVELY SPRAYING ABOUT OUTSIDE THE MACHINE? NO. IS LEAKED LIQUID TYPE KNOWN? BIOHAZARDOUS OR NON-BIOHAZARDOUS? BIOHAZARDOUS. DID THE LEAKED LIQUID HAVE BLEACH MIXED IN? NO. WAS ANYONE INJURED DUE TO THE LEAKED LIQUID? NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14644329 ↗
• MalfunctionMar 23, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT THE FACSCANTO¿ 10-COLOR CONFIGURATION LEAKED WASTE FLUID OUTSIDE THE INSTRUMENT. THERE WAS NO ADVERSE USER OR PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "FLUID UNDER WET CART" WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? NO. WAS THE LEAK IN A CUSTOMER ACCESSIBLE LOCATION? YES. WHAT WAS THE FLUID THAT LEAKED? WASTE. WHAT IS THE SOURCE OF LEAK -- WASTE LINE OR NON-WASTE LINE? WASTE LINE. WAS THE CUSTOMER EXPOSED TO BLOOD OR BODILY FLUIDS? NO. WAS THERE ANY PHYSICAL HARM TO THE CUSTOMER AS A RESULT OF THE LEAK ? NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13870323 ↗
• MalfunctionDec 10, 2021Contamination; Contamination

  IT WAS REPORTED THAT THE FACSCANTO¿ 10-COLOR CONFIGURATION HAD ISSUES WITH CARRYOVER WHILE RUNNING IT MANUALLY. A TUBE OF FRESH WATER WAS RUN THROUGH WITH EVENTS AND POPULATIONS SHOWING UP FROM PREVIOUS TUBES. ERRONEOUS RESULTS WERE NOT REPORTED TO CLINICIANS, AND THERE WAS NO REPORT OF ADVERSE PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 'THEY ARE HAVING A CARRY OVER ISSUE WHEN RUNNING IT IN MANUAL MODE. EVERY TUBE THEY ARE SEEING UNEXPLAINED POPULATIONS. WHEN THEY RUN A TUBE THEY RUN A TUBE OF FRESH WATER AND THEY ARE SEEING A TON OF EVENTS FROM THE PREVIOUS TUBE. THEY DID A LONG CLEAN ALREADY AND IT DID NOT HELP." "ARE YOU USING THIS PRODUCT FOR CLINICAL DIAGNOSTIC TEST? Y. WERE ERRONEOUS RESULTS REPORTED AND USED TO TREAT A PATIENT? N. WAS THERE ANY INJURY OR POTENTIAL INJURY? N".

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12977829 ↗
• MalfunctionDec 6, 2021Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE TESTING PATIENT SAMPLES ON A BD FACSCANTO¿ ERRONEOUS RESULTS WERE OBTAINED. THE % OF CD19 ARE LOWER THAN EXPECTED, IN THE INTERNAL MULTICHECK THE % WERE CORRECT. THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER, TRANSLATED FROM ITALIAN TO ENGLISH: THE% OF CD19 IN THE ANALYZED SAMPLES ARE LOWER THAN EXPECTED. HOWEVER, IN THE INTERNAL MULTICHECK CONTROL THE PERCENTAGES ARE CORRECT. 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.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12936545 ↗
• MalfunctionNov 16, 2021Contamination; Contamination

  IT WAS REPORTED THAT WHILE RUNNING BD FACSCANTO¿ CARRYOVER OCCURRED. THERE WAS NO REPORT OF PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CST FAIL, CARRY OVER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12823560 ↗
• MalfunctionNov 3, 2021Signal Artifact/Noise; Signal Artifact/Noise

  IT WAS REPORTED THAT WHILE USING FACSCANTO IVD 10 COLOR CONFIGURATION HAD A CARRYOVER ISSUE. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: PATIENT SAMPLES CHECKLIST FROM WO. 1) ARE THERE ERRONEOUS RESULTS ON PATIENT SAMPLES FROM DIAGNOSTIC TEST? NO. IT WAS REPORTED THAT THERE WAS A CARRY OVER ISSUE. IS INSTRUMENT ASSURITY LINC ENABLED? N. CUSTOMER PROBLEM: CARRY OVER ISSUE, MEASURED AT .22%. FSE IS AWARE OF THE ISSUE. STEPS TAKEN WITH CUSTOMER/TROUBLESHOOTING: NONE. NEXT STEPS (IF NECESSARY): DISPATCHING CASE AT CUSTOMERS REQUEST. ARE YOU USING THIS PRODUCT FOR CLINICAL DIAGNOSTIC TEST? Y. WERE ERRONEOUS RESULTS REPORTED AND USED TO TREAT A PATIENT? N. WAS THERE ANY INJURY OR POTENTIAL INJURY? N. LEAK (IF YES EXPLAIN)? N. 1. WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? N/A. 2. WAS THE LEAK IN A CUSTOMER ACCESSIBLE LOCATION? N/A. 3. WHAT WAS THE FLUID THAT LEAKED? N/A. 4. WHAT IS THE SOURCE OF LEAK -- WASTE LINE OR NON-WASTE LINE? N/A. 5. WAS THE CUSTOMER EXPOSED TO BLOOD OR BODILY FLUIDS? N/A. 6. WAS THERE ANY PHYSICAL HARM TO THE CUSTOMER AS A RESULT OF THE LEAK N/A. SOFTWARE VERSION? UNKNOWN. RESOLUTION ACHIEVED (Y/N)? N. FOLLOW UP REQUIRED (Y/N)? Y. LIST OF PA

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12748785 ↗
• MalfunctionOct 26, 2021Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT WHILE USING FACSCANTO IVD 10 COLOR CONFIGURATION LEAKED. THERE WAS NO USER IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LEAK BELOW THE FLUIDICS CARRIAGE. WE DON'T KNOW WHERE IT CAME FROM BUT THIS MORNING THERE WAS A STRANGE NOISE. WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? NO. WAS THE LEAK IN A CUSTOMER ACCESSIBLE LOCATION? NO. WHAT WAS THE FLUID THAT LEAKED? SHEATH. IF SO WAS THERE LEAKED FLUID IN UNDER PRESSURE? YES. WHAT IS THE SOURCE OF LEAK -- WASTE LINE OR NON-WASTE LINE? NON WASTE LINE. IF WASTE LINE, WHETHER IT IS MIXED WITH BLEACH OR CONTAMINATION? NO. WAS THE CUSTOMER EXPOSED TO BLOOD OR BODILY FLUIDS? NO. WAS THERE ANY PHYSICAL HARM TO THE CUSTOMER AS A RESULT OF THE LEAK? NO. SOLUTION COMMENTS: THE REPLACEMENT OF THE FITTING + TUBING SOLVED THE PROBLEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12698943 ↗