FACS 647205Recalls & reported problems

Summary

The FDA's MAUDE database contains 123 adverse event reports that list this exact device (DI 00382906472052), received between May 19, 2020 and Feb 6, 2026 — classified as 3 injuries, 120 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (92 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 123 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 6, 2026Contamination

  IT WAS REPORTED THAT DURING USE OF BD FACS¿ SAMPLE PREP ASSISTANT III, FOREIGN MATTER/CONTAMINATION IN INSTRUMENT THAT IMPACTED PATIENT RESULTS WAS OBSERVED. CONTAMINANT IS IN A POSITION WHERE IT IMPACTED A READOUT TO BE USED CLINICALLY. THERE WAS NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THAT SAMPLES NOT BEING PROCESSED CORRECT. CUSTOMER REPLACED SYRINGE BUT ISSUE PERSISTS. PATIENT SAMPLES CHECKLIST: 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. NO. 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. PATIENT SAMPLES CONTAMINATED. 2. PLEASE DESCRIBE ANY ADDITIONAL DETAILS: GO TO PATIENT SAMPLES CHECKLIST. SAMPLES WERE NOT PROPERLY PROCESSED AND THERE WAS A R

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24277294 ↗
• InjuryDec 12, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT WHILE WASHING THE FILTER OF THE BD FACS¿ SAMPLE PREP ASSISTANT III, LIQUID SPLASHED INTO THE USER¿S EYES. THE USER WAS NOT WEARING THE APPROPRIATE PPE AS SPECIFIED IN THE IFU, AND THERE WAS NO PRODUCT FAILURE ASSOCIATED WITH THE INSTRUMENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE USER REPORTED THAT THE PREVIOUS WEEK, DURING USER MAINTENANCE, WHEN THE FILTER OF THIS EQUIPMENT WAS OPENED, SHE WAS SPLASHED WITH LIQUID FROM THE EQUIPMENT'S WASTE PRODUCTS INTO HER EYES. THE USER REPORTED THIS AND FOLLOWED THE INSTITUTION'S PROCEDURES FOR THIS TYPE OF SITUATION, BUT IT WAS ONLY AFTER THE ENGINEER'S VISIT THAT THE INCIDENT WAS REPORTED TO BD. ADDITIONAL INFORMATION PROVIDED BY THE TECHNICAL SERVICES TEAM: THE INCIDENT OCCURRED WHEN THE USER WAS WASHING THE INSTRUMENT¿S FILTER, AFTER IT HAD BEEN REMOVED FROM THE EQUIPMENT. IT IS REPORTED THAT THE USER REMOVED THE FILTER WITHOUT ANY ISSUES, AND WHILE WASHING IT UNDER RUNNING WATER, LIQUID SPLASHED INTO THEIR EYES. THE USER WAS NOT WEARING SAFETY GLASSES. THERE ARE NO COMPLAINTS OF PROBLEMS RELATED TO THE INSTRUMENT OR BD DISPOSABLES. THERE WERE NO IMMEDIATE CONSEQUENCES FOR THE USER AT THE TI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23794926 ↗
• MalfunctionMay 19, 2025Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE USING BD FACS¿ SAMPLE PREP ASSISTANT III THE CUSTOMER REPORTED ERRONEOUS RESULTS THAT WERE REPORTED TO A CLINICIAN. NO PATIENT INJURY OR DELAY IN TREATMENT WAS REPORTED. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: "CUSTOMER REPORTED 2 OF THEIR INSTRUMENTS ARE GIVING AN ABNORMAL RESULT"

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22045122 ↗
• MalfunctionMar 22, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE USING BD FACS¿ SAMPLE PREP ASSISTANT III ERRONEOUS RESULTS WERE OBTAINED. NO PATIENT IMPACT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTED THE SPA IS NOT ADDING REAGENT TO THE SAMPLE TUBE. A FULL RACK OF SAMPLES WAS PREPPED, THE FIRST 12 LOOKED AND RAN FINE, BUT THE REMAINING 28 DID NOT HAVE ANY REAGENTS IN THEM (ERRONEOUS RESULTS). THEY DISCARDED THE AFFECTED SAMPLES AND PREPPED THE PRIMARY SAMPLES AGAIN ON ANOTHER SPA WHERE THEY PROCESSED SUCCESSFULLY. SAMPLES WERE IMPROPERLY PREPARED BY THE SPA AND WHEN THEY WERE RUN ON THE CYTOMETER THEY PRODUCED ERRONEOUS PATIENT RESULTS, WHICH WERE NOTICED BY THE LAB TECHNICIANS WHO DISCARDED THE SAMPLES AND RE-PREPPED NEW ONES ON ANOTHER SPA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18961262 ↗
• MalfunctionJan 18, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT CARRYOVER WAS OBSERVED ON PATIENT SAMPLES DURING USE WITH THE BD FACS¿ SAMPLE PREP ASSISTANT III. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IN "WO-03192403" IT HAS BEEN STATED AS "SAMPLE CARRYOVER IN PIPETTING" AS PART OF COMPLIANCE REVIEW COULD YOU PLEASE ANSWER THE FOLLOWING SAFETY QUESTIONS 1. WAS THE CARRYOVER OBSERVED IN PATIENT SAMPLES? A: YES, IT WAS OBSERVED IN PATIENT SAMPLES. SYSTEM PIPETTING FAILURE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18539507 ↗
• MalfunctionNov 14, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT BD FACS¿ SAMPLE PREP ASSISTANT III HAS ACCURACY ISSUES OCCURRING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: ACCURACY ISSUES. THEY HAVE REBOOTED THE INSTRUMENT AND COMPUTER. NO CHANGE 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? NO 3. IF PATIENT SAMPLES WERE REDRAWN, WAS THERE ANY CHANGE OR DELAY OF TREATMENT? NO 4. WAS THERE ANY PHYSICAL HARM/INJURY TO THE PATIENT DUE TO THE ISSUE? NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18130721 ↗
• InjuryAug 29, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT ERRONEOUS RESULTS WERE OBSERVED DURING USE WITH THE BD FACS¿ SAMPLE PREP ASSISTANT III. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WERE PATIENT SAMPLES INVOLVED? YES. WERE ERRONEOUS RESULTS REPORTED TO THE CLINICIAN? YES. WERE PATIENTS TREATED BASED ON ERRONEOUS RESULTS? YES. (B)(6): (B)(6) 2023 07:57:29 (GMT) . ERRONEOUS RESULTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17646541 ↗
• MalfunctionJul 18, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT DURING USE WITH THE BD FACS¿ SAMPLE PREP ASSISTANT III THERE WERE ERRONEOUS RESULTS ON PATIENT SAMPLES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CORRECTION FROM THE WFI- CHECKLIST: ARE THERE ERRONEOUS RESULTS ON PATIENT SAMPLES FOR DIAGNOSTIC TEST? NO. THE SAMPLES THAT ARE PREPARED BY THE SPA II EQUIPMENT DO NOT PROVIDE READINGS AND ARE INVALIDATED BY THE CYTOMETER. ¿ ARE THERE ERRONEOUS RESULTS ON PATIENT SAMPLES FOR 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? NO. WHAT IS THE CURRENT MEDICAL STATUS?NO. WAS CARRYOVER OBSERVED ON PATIENT SAMPLES? NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17343458 ↗
• MalfunctionMay 24, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  IT WAS REPORTED THAT WHILE USING THE BD FACS¿ SAMPLE PREP ASSISTANT III THAT THERE WAS ERRONEOUS RESULTS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: 16.08- (B)(6), FSE WHO VISITED CUSTOMER CORRECTED (B)(6): 1. ARE THERE ERRONEOUS RESULTS ON PATIENT SAMPLES FROM DIAGNOSTIC TEST? NO. 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? NO. 3. IF PATIENT SAMPLES WERE REDRAWN, WAS THERE ANY CHANGE OR DELAY OF TREATMENT? NO. 4. WAS THERE ANY PHYSICAL HARM/INJURY TO THE PATIENT DUE TO THE ISSUE? (IF YES OR UNKNOWN, GO TO QUESTION #5. IF NO, NO FURTHER QUESTIONS REQUIRED.) NO. 5. PROVIDE DETAILS - HOW AND TO WHAT EXTENT? 6. WHAT IS THE CURRENT MEDICAL STATUS? IT DOESN'T ADD THE BLOOD. WE'VE REPLACED THE PROBE BUT IT DOESN'T HELP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16997945 ↗
• MalfunctionMar 1, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT BD FACS¿ SAMPLE PREP ASSISTANT III HAD A LEAKAGE OF BIOHAZARD THAT WAS NOT CONTAINED WITHIN THE INSTRUMENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTED. THERE IS LIQUID FROM THE TOWER. WAS THE LEAK LIQUID OR AIR? LIQUID. WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? NOT CONTAINED. (IF NOT CONTAINED) WAS THERE SPRAY OF FLUID UNDER PRESSURE? NO. WHAT WAS THE FLUID THAT LEAKED? BIOHAZARD. WHAT IS THE SOURCE OF LEAK ¿ BEFORE WASTE LINE OR AFTER WASTE LINE? AFTER WASTE LINE -5B (IF WASTE LINE) ¿ WAS WASTE MIXED WITH BLEACH OR DECONTAMINATE? NO. WAS THE CUSTOMER/BD PERSONNEL PHYSICALLY IN CONTACT WITH THE FLUID? NO.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16461520 ↗
• MalfunctionFeb 28, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT WHILE USING THE BD FACS¿ SAMPLE PREP ASSISTANT III THAT THERE WAS A WASTE LEAK. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LEAKAGE AT WASH STATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16455700 ↗
• MalfunctionFeb 16, 2023Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT WHILE USING THE BD FACS¿ SAMPLE PREP ASSISTANT III THAT THERE WAS A LEAK. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WASH TOWER IS OVERFLOWING. CUSTOMER HAS ALREADY TRIED CLEANING THE INLINE FILTER.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16388868 ↗
• MalfunctionFeb 8, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT WHILE USING THE BD FACS¿ SAMPLE PREP ASSISTANT III THAT THERE WAS A LEAKAGE OF BIOHAZARD NOT CONTAINED WITHIN INSTRUMENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER (B)(6): (B)(6) 2023 ( IST ) COPIED FROM SMAX CHECKLIST. - (B)(4) 1. WAS THE LEAK FLUID OR AIR? (IF FLUID, GO TO QUESTION #2. IF AIR, NO FURTHER QUESTIONS REQUIRED.) LIQUID 2. WAS THE LEAK CONTAINED WITHIN THE INSTRUMENT? ( IF NOT CONTAINED, GO TO QUESTION #3. IF CONTAINED, NO FURTHER QUESTIONS REQUIRED.) NOT CONTAINED USER TOLD IT WAS PROBABLY FLUSHING LIQUID AND NOT PROBES BUT SHE HAD GLOVES ON AND DISINFECTED ALL THE SURFACES (B)(6) : (B)(6) 2022 15:45:25 (GMT) WE HAVE AN OVERFLOW OF THE WASHING STATION AT SPA III. SINCE THERE IS NO PLUG MATERIAL IN THE FILTER, I ASSUME THAT ANOTHER CONNECTOR IS BLOCKED. (THE NEEDLE HAS 1280 PUNCTURES, BUT IT DOESN'T LOOK BAD, BUT I THINK IT WOULD BE GOOD IF IT COULD BE EXCHANGED AS PART OF THE SERVICE, BECAUSE THERE ARE MANY PUNCHED-OUT RUBBER PARTICLES IN THE DEVICE).

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16318662 ↗
• MalfunctionJan 23, 2023Leak/Splash; Leak/Splash

  IT WAS REPORTED THAT DURING USE WITH THE BD FACS¿ SAMPLE PREP ASSISTANT III THAT LEAKAGE UNDER PRESSURE OCCURRED OUTSIDE OF THE INSTRUMENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THAT INSTRUMENT IS NOT PIPETTING PROPERLY. (B)(4) : 2023-01-17 20:09:49 (GMT). CALLER REPORTS THAT THE BLOOD IS SPLATTERED INSIDE THE TUBES AND SOME INSIDE THE MACHINE - NO ASPIRATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16229114 ↗
• MalfunctionDec 23, 2022Fluid/Blood Leak

  IT WAS REPORTED THAT BD FACS¿ SAMPLE PREP ASSISTANT III LEAKAGE CONTAINED WITHIN THE INSTRUMENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER LEAKAGE CONTAINED WITHIN THE INSTRUMENT IN A CUSTOMER ACCESSIBLE LOCATION. LEAKED FLUID: SHEATH FLUID. THE SOURCE WAS NON-WASTE LINE. CUSTOMER WAS NOT EXPOSED TO BLOOD OR BODILY FLUIDS. THE CUSTOMER SUFFERED NO PHYSICAL HARM AS RESULT OF THE LEAK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16043434 ↗
• MalfunctionDec 22, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT WHILE USING THE BD FACS¿ SAMPLE PREP ASSISTANT III THAT THERE WAS LEAKING FROM BOTTOM OF INSTRUMENT AFTER RUN OF 40 TUBES. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LEAKING FROM BOTTOM OF INSTRUMENT AFTER RUN OF 40 TUBES.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16037820 ↗
• MalfunctionDec 22, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT BD FACS¿ SAMPLE PREP ASSISTANT III THERE WAS A BIOHAZARD LEAK. NO INQUIRES OCCURRED. THE FOLLOWING INFORMATION WAS PROVIDE BY THE INITIAL REPORTER: THE CUSTOMER REPORTED A LEAK INSIDE THE INSTRUMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16034818 ↗
• MalfunctionDec 16, 2022Fluid/Blood Leak; Free or Unrestricted Flow

  IT WAS REPORTED THAT BD FACS¿ SAMPLE PREP ASSISTANT III CONTINUOUS FLOODING OF INSTRUMENT HAS OCCURRED AFTER SEVERAL CLEANING'S. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CONTINUOUS FLOODING OF INSTRUMENT, EVEN AFTER MULTIPLE FILTER CLEANING'S OCCURRED. THE LEAK APPEARS TO BE A BIOHAZARD LIQUID. THE LEAKAGE DID NOT COME IN CONTACT TO PERSONNEL AND NO INJURIES WERE REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16000045 ↗
• MalfunctionNov 18, 2022Infusion or Flow Problem

  IT WAS REPORTED THAT WHILE USING THE BD FACS¿ SAMPLE PREP ASSISTANT III THAT THE WASHING STATION OVERFLOWS. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CUSTOMER REPORTS THAT THE WASHING STATION OVERFLOWS. CUSTOMER CLEANED THE FILTER BUT THE ISSUE PERSISTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15827648 ↗
• MalfunctionNov 18, 2022Non Reproducible Results; Non Reproducible Results

  IT WAS REPORTED THAT WHILE USING THE BD FACS¿ SAMPLE PREP ASSISTANT III THAT CD45 COUNTS ARE HIGHER THAN THE TOTAL CBC. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: CD45 COUNTS ARE HIGHER THAN THE TOTAL CBC.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15822700 ↗
• MalfunctionNov 16, 2022Excess Flow or Over-Infusion; Mechanical Problem

  IT WAS REPORTED THAT WHILE USING THE BD FACS¿ SAMPLE PREP ASSISTANT III THAT THE WASH TOWER IS OVERFLOWING AND THE LOCK IS NOT FUNCTIONING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WASH TOWER OVERFLOWING AND LOCK NOT FUNCTIONING.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15811182 ↗
• MalfunctionNov 15, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT WHILE USING THE BD FACS¿ SAMPLE PREP ASSISTANT III THAT THE WASH STATION IS OVERFLOWING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: WASH STATION IS OVERFLOWING. THEY CLEANED THE IN-LINE FILTER BUT IT DID NOT HELP.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15798140 ↗
• MalfunctionOct 20, 2022Leak/Splash

  IT WAS REPORTED THAT WHILE USING THE BD FACS¿ SAMPLE PREP ASSISTANT III THAT THERE WAS LEAKING FROM THE BACK OF THE INSTRUMENT. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: LEAKING FROM BACK OF INSTRUMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15642978 ↗
• MalfunctionOct 20, 2022Overfill

  IT WAS REPORTED THAT WHILE USING THE BD FACS¿ SAMPLE PREP ASSISTANT III THAT THE WASHING COLUMN OF THE PROBE IS OVERFLOWING. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: THE CUSTOMER REPORTS THAT THE WASHING COLUMN OF THE PROBE IS OVERFLOWING. THE CUSTOMER CLEANED THE FILTER (WHICH WAS CLEAN) BUT THE PROBLEM PERSISTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15642814 ↗
• MalfunctionOct 17, 2022Fluid/Blood Leak; Fluid/Blood Leak

  IT WAS REPORTED THAT WHILE USING THE BD FACS¿ SAMPLE PREP ASSISTANT III THAT THE CUSTOMER RAN SAMPLE HOWEVER WHEN THE INSTRUMENT WAS DONE THERE WAS LIQUID AND BLOOD INSIDE. LEAK. THE FOLLOWING INFORMATION WAS PROVIDED BY THE INITIAL REPORTER: IT WAS REPORTED BY THE CUSTOMER THAT THE SENSOR HAS BEEN REPLACED. ERROR MESSAGE WENT AWAY CUSTOMER RAN SAMPLE HOWEVER WHEN THE INSTRUMENT WAS DONE THERE WAS LIQUID AND BLOOD INSIDE. CUSTOMER PROBLEM: INTERNALLY LEAKING. STEPS TAKEN WITH CUSTOMER/ TROUBLESHOOTING: INITIALLY THE ERROR "WASTE TANK FULL" APPEARED. THE SENSOR HAS BEEN REPLACED. ERROR MESSAGE WENT AWAY. CUSTOMER RAN SAMPLE HOWEVER WHEN THE INSTRUMENT WAS DONE THERE WAS LIQUID AND BLOOD INSIDE. LEAK. CUSTOMER REACHED OUT TO FSE (B)(6). I ASKED THE CUSTOMER TO CHECK TO SEE IF THE WASH STATION IS OVERFLOWING, UPON CHECKING THE WASTE STATION IS FULL OF FLUID. I HAD HER TRY TO CLEAN THE IN-LINE FILTER BUT SHE SAID SHE COULD NOT UNSCREW IT TO CLEAN IT. SHE WOULD LIKE THE FSE. INITIALLY THE ERROR "WASTE TANK FULL" APPEARED. THE SENSOR HAS BEEN REPLACED. ERROR MESSAGE WENT AWAY. CUSTOMER RAN SAMPLE HOWEVER WHEN THE INSTRUMENT WAS DONE THERE WAS LIQUID AND BLOOD INSIDE. LEAK. CUSTOMER REACH

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15614664 ↗