CELL-DYN 08H00-01Recalls & reported problems

Summary

The FDA's MAUDE database contains 90 adverse event reports that list this exact device (DI 00380740016616), received between Aug 31, 2016 and Mar 31, 2026 — classified as 5 injuries, 85 malfunctions.

The most frequently reported specific device problem is “Low Test Results” (44 reports).

1 FDA recall record name this device's identifier, 1 still open.

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.

Recalls naming this device

1. Oct 19, 2023Open, Classified

   The devices contain a dry natural rubber (latex) subcomponent, which are not labeled as containing dry natural rubber(latex).

   Z-0604-2024 · Root cause: Under Investigation by firm · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 90 reports, in the reporter's own words as published by the FDA.

• MalfunctionMar 31, 2026Low Test Results

  THE CUSTOMER OBSERVED FALSELY DEPRESSED WHITE BLOOD CELL (WBC) VALUES GENERATED ON A CELL-DYN SAPPHIRE. AFTER AN INTERVAL WITHOUT MEASUREMENTS, WBC WOULD BE ZERO AND PLATELETS WOULD ALSO BE SLIGHTLY LOW, RUNNING A SECOND TIME WOULD PRODUCE RESULTS WITH NO ISSUES. NO ACTUAL DATA HAD BEEN PROVIDED AT THAT TIME. THE CUSTOMER REPLACED THE PERISTALTIC PUMP, BUT CONTINUED TO SEE FALSELY DEPRESSED WBC AND ABSOLUTE NEUTROPHILS FOR ONE PATIENT SAMPLE. ON 13MAR2026, SID 52600016939 INITIAL WBC RESULT = 0.130 10E3/UL, REPEAT RESULT = 9.08 10E3/UL; INITIAL SEG = 0.013 10E3/UL, REPEAT RESULT = 7.19 10E3/UL. THERE WAS NO IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24746353 ↗
• MalfunctionNov 20, 2025Computer Software Problem; Computer Software Problem

  THE CUSTOMER STATED THAT PATIENT SAMPLE RESULTS ARE INTERMITTENTLY BEING RECOGNIZED AS CONTROL H WHEN GENERATED ON THE CELL DYN SAPPHIRE. THE CUSTOMER WOULD SCAN THE BARCODE OF THE PATIENT SAMPLE, AND THE BARCODE NUMBER DISPLAYED ON THE SCREEN OF THE INSTRUMENT IS CORRECT, HOWEVER THE SAMPLE IS RECOGNIZED AS CONTROL H. THE CUSTOMER WOULD REPEAT TESTING ON THE SAME SAMPLE, AND THE SAMPLE IS RECOGNIZED AS A PATIENT SAMPLE AND NOT A CONTROL. THERE WERE NO DISCREPANT RESULTS REPORTED. THERE WAS NO ISSUE WITH QC AND NO FLAGS OR ERROR MESSAGES GENERATED. THE FIELD SERVICE ENGINEER (FSE) ARRIVED ONSITE TO INSPECT THE CELL DYN SAPPHIRE AND FOUND THAT THE DEFAULT SETTING FOR THE HOST MEASUREMENT REQUEST WAS ¿QC¿. THEREFORE, WHEN THERE IS A COMMUNICATION ISSUE SUCH AS A QUERY TIMEOUT, THE INSTRUMENT AUTOMATICALLY RECOGNIZES THE SAMPLE AS A QC SAMPLE. THE DEFAULT SETTING WAS CHANGED FOR THE MEASUREMENT REQUEST TO ¿PATIENT SAMPLE¿. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23611690 ↗
• MalfunctionJun 16, 2025Leak/Splash; Leak/Splash

  THE CUSTOMER OBSERVED AN ASTERISK (*) AND A SHORT SAMPLE MESSAGE FOR ALL SAMPLES GENERATED ON THE CELL-DYN SAPPHIRE ANALYZER. THE HBG CUP AND RBC CUP DID NOT DRAIN AND REPORTED THE WASH CUP (WC) #4 AND WC #3 WAS FULL. THE CUSTOMER REPORTED TWO USERS WERE SPRAYED IN THE FACE WITH LIQUID FROM THE LEFT FLOW PANEL WHILE OBSERVING. THE CUSTOMER MENTIONED THE USERS DID NOT TAKE ANY ACTIONS AFTER BEING SPRAYED IN THE FACE WITH THE LIQUID. NO IMPACT TO PATIENT MANAGEMENT OR IMPACT TO USER SAFETY WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22211362 ↗
• MalfunctionNov 18, 2024Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER OBSERVED DISCREPANT WHITE BLOOD COUNT (WBC) AND NEUTROPHIL ABSOLUTE COUNT GENERATED FROM CELL DYN SAPPHIRE ANALYZER FOR ONE PATIENT. THE RESULTS PROVIDED WERE: NEUTROPHIL ABSOLUTE INITIAL=1.00 10E3/L /REPEATED=0.1 10E3/L ADDITIONAL INFORMATION PROVIDED: WBC=5.82 10E3/L /REPEATED=5.21 10E3/L THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20706176 ↗
• MalfunctionJul 29, 2024Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY DECREASED HEMOGLOBIN RESULTS FOR TWO PATIENTS ON A CELL-DYN SAPPHIRE ANALYZER. THE FOLLOWING DATA WAS PROVIDED: SAMPLE ID (B)(6) INITIAL RESULT WAS 4.7 MMOL/L, WHICH WAS RELEASED TO THE PHYSICIAN. THE SAMPLE WAS REPEATED, ON ANOTHER CELL-DYN SAPPHIRE ANALYZER, AND THE RESULT WAS 5.6 MMOL/L, WHICH THE CUSTOMER BELIEVES IS THE CORRECT RESULT FOR THIS PATIENT. SAMPLE ID (B)(6) INITIAL RESULT WAS 4.7, REPEAT RESULT WAS 5.1 MMOL/L THE CUSTOMER STATED THAT BECAUSE OF THE LOW HEMOGLOBIN RESULT FOR SAMPLE ID (B)(6), THE PATIENT WAS GIVEN A BLOOD TRANSFUSION; HOWEVER, THE REPEAT RESULT FOR THIS PATIENT, WHICH WAS DEEMED CORRECT BY THE CUSTOMER, WAS ALSO A LOW HEMOGLOBIN RESULT. THERE WAS NO REPORTED IMPACT TO THE PATIENT DUE TO THE TRANSFUSION. THERE WAS NO OTHER IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19856134 ↗
• MalfunctionOct 5, 2023Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY DECREASED WBC RESULTS FOR MULTIPLE PATIENT SAMPLES WHEN RUNNING ON THE CELL DYN SAPPHIRE. THE CUSTOMER PROVIDED DATA FOR ONE PATIENT: ON (B)(6) 2023: SID (B)(6) WAS A FIRST DRAW THAT GENERATED WBC RESULT OF 0.142 X 10E3/UL WHICH WAS REPORTED TO THE MEDICAL PROVIDER. SID (B)(6) WAS A REDRAW FROM SAME PATIENT THAT GENERATED NORMAL WBC RESULT OF 11.1 X 10E3/UL CUSTOMER RERAN THE FIRST SAMPLE SID (B)(6) WHICH GENERATED A NORMAL WBC RESULT OF 10.6 X10E3/UL THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17882891 ↗
• MalfunctionOct 5, 2023Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY DECREASED WBC RESULTS GENERATED ON THE CELL-DYN SAPPHIRE ANALYZER FOR MULTIPLE PATIENTS. THE ONE RESULT EXAMPLE PROVIDED WERE: THE ONE RESULT EXAMPLE PROVIDED WERE: ON (B)(6)2023 SID (B)(6)INITIAL WBC RESULTS = 0.048 X 10E3/UL /REPEATED ON 43110AZ=18.2 10E3/UL /ON (B)(6)2023 REPEATED ON 60088AZ=16.8 10E3/UL NEUTROPHIL ABSOLUTE=0.002 10E3/UL /REPEATED ON 43110AZ=11.8 10E3/UL / ON 26SEP2023 REPEATED ON 60088AZ=473/ 10E3/UL THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17880027 ↗
• MalfunctionSep 29, 2023Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY DECREASED WBC RESULTS GENERATED ON THE CELL-DYN SAPPHIRE ANALYZER FOR TWO PATIENTS. THE CUSTOMER STATED THERE WAS NO FLAGS ON THE WBC RESULTS. THE SAMPLES WERE REPEATED AND NORMAL RESULTS WERE OBTAINED. THE FOLLOWING DATA WAS PROVIDED: INITIAL WBC RESULTS = 1 X 10E3/UL. REPEAT WBC RESULT = NORMAL. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17843533 ↗
• MalfunctionAug 7, 2023Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY DECREASED WHITE BLOOD CELL (WBC) COUNT AND ABSOLUTE NEUTROPHIL COUNT FOR ONE PATIENT ON A CELL-DYN SAPPHIRE ANALYZER. THE FOLLOWING DATA WAS PROVIDED: INITIAL WBC RESULT WAS 0.393, REPEAT WAS 7.60 10E3/UL; INITIAL ABSOLUTE NEUTROPHIL RESULT WAS 0.054, REPEAT WAS 4.98 10E3/UL ALL OTHER CBC DATA PROVIDED WAS REVIEWED AND NO OTHER PARAMETERS MEET REPORTING CRITERIA. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17476619 ↗
• MalfunctionJul 6, 2023Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY DECREASED WBC RESULT GENERATED ON THE CELL-DYN SAPPHIRE ANALYZER FOR THREE PATIENTS. THE SAMPLES WERE REPEATED ON ANOTHER SAPPHIRE ANALYZER WHICH YIELDED NORMAL RESULTS. IT WAS NOTED THAT THE ANALYZER DID NOT GENERATE ANY FLAG ON THE INITIAL RESULTS. THE FOLLOWING DATA WAS PROVIDED: SID (B)(6) INITIAL WBC RESULT = 0.06 10E3/UL, REPEAT RESULT (ANOTHER SAPPHIRE) = 7.64 10E3/UL. SID (B)(6) INITIAL WBC RESULT = 0.009 10E3/UL; REPEAT RESULT (ANOTHER SAPPHIRE) = 5.47 10E3/UL. SID (B)(6) INITIAL WBC RESULT = 0.8 10E3/UL; REPEAT RESULT (ANOTHER SAPPHIRE) = 6.1 10E3/UL. CUSTOMER¿S REFERENCE RANGE: 4.8 TO 10.8 10E3/UL NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17266471 ↗
• MalfunctionJun 19, 2023Low Test Results; Low Test Results

  THE CUSTOMER REPORTED FALSELY DECREASED WBC RESULTS FOR ONE PATIENT WHEN RUNNING ON THE CELL-DYN SAPPHIRE ANALYZER. THE FOLLOWING DATA WAS PROVIDED (WBC NORMAL RANGE: 4.5 ¿ 11.2 X 10E9/L): SID (B)(6): ON (B)(6)2023 = INITIAL WBC RESULT = 0.008 X 10E9/L (8/UL) ON (B)(6)2023 =REPEAT WBC RESULT = 21.8 X 10E9/L (21800/UL) THE HEMOGLOBIN AND PLATELET RESULTS WERE PROVIDED FOR REFERENCE AS THEY CORRELATE WITH EACH OTHER AND THERE IS NO DISCREPANCY (HEMOGLOBIN: INITIAL RESULT = 8.76 / REPEAT RESULT = 9.3; PLATELET: INITIAL RESULT = 691 / REPEAT RESULT = 706). THE CUSTOMER FAILED TO MANUALLY REVIEW THE BLOOD SMEAR OF THE PATIENT SAMPLE TO CONFIRM THE WBC RESULTS. THE FALSELY DECREASED WBC RESULT WAS REPORTED TO THE MEDICAL PROVIDER, RESULTED IN A BONE MARROW ASPIRATE/BIOPSY TO BE PERFORMED ON THE PATIENT. THERE WAS NO HARM TO THE PATIENT. THERE WAS NO ADDITIONAL IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17150983 ↗
• MalfunctionJun 15, 2023Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED THAT THE CELL-DYN SAPPHIRE SYSTEM WAS GENERATING ERROR CODE 1061-UNEXPECTED TUBE STATUS AT MIXHEAD AND FURTHER REPORTED FALSELY LOW WBC RESULTS FROM SAMPLES IN THE FIRST POSITION ON THE ANALYZER RACK. THE CUSTOMER REPORTED THAT REPEAT TESTING ON THE SAME ANALYZER WAS PERFORMED AND PROVIDED THE FOLLOWING DATA: (CUSTOMER NORMAL RANGE - NORMAL RANGE: 5-10 ^X3 /UL) SAMPLE ID (B)(6) INITIAL RESULT WAS 0.331, REPEAT RESULT WAS 9.8. SAMPLE ID (B)(6) INITIAL RESULT WAS 0.212, REPEAT RESULT WAS 12.1. SAMPLE ID (B)(6) INITIAL RESULT WAS 0.048, REPEAT RESULT WAS 15.1. SAMPLE ID (B)(6) INITIAL RESULT WAS 0.239, REPEAT RESULT WAS 9.9 . THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17136152 ↗
• MalfunctionMay 24, 2023Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY DECREASED WHITE BLOOD CELL (WBC) AND NEUTROPHIL COUNTS FOR ONE PATIENT ON A CELL-DYN SAPPHIRE ANALYZER. THE FOLLOWING DATA WAS PROVIDED: SAMPLE ID (B)(6) INITIAL WBC RESULT WAS 0.568, REPEATS WERE 7.912 AND 7.428 10E9/L; INITIAL NEUTROPHIL RESULT WAS 0.068, REPEATS WERE 5.609 AND 5.209 10E9/L THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16997907 ↗
• MalfunctionMay 15, 2023Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY DECREASED WBC AND NEUTROPHIL RESULTS GENERATED ON THE CELL-DYN SAPPHIRE ANALYZER FOR 2 SAMPLES THAT WERE NOT REPORTED OUT. THE SAMPLES WERE REPEATED WITH LOWER RESULTS. THE FOLLOWING DATA WAS PROVIDED: BOTH SAMPLES PROCESSED ON (B)(6) 2023. SID (B)(6) INITIAL WBC RESULT = 0.436 10E3/UL REPEAT WBC = 11.7 10E3/UL INITIAL NEUTROPHIL RESULT = 0.024 10E3/UL REPEAT RESULT = 7.86 10E3/UL. SID (B)(6) INITIAL WBC RESULT = 0.365 10E3/UL REPEAT WBC = 7.77 10E3/UL INITIAL NEUTROPHIL RESULT = 0.049 10E3/UL REPEAT RESULT = 5.64 10E3/UL NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16931318 ↗
• MalfunctionApr 17, 2023Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY DECREASED WHITE BLOOD CELL (WBC) RESULTS ON CELL-DYN SAPPHIRE ANALYZER FOR ONE PATIENT. THE RESULTS PROVIDED WERE: ON (B)(6) 2023 SID (B)(6) INITIAL WBC=0.572 10E3/UL /REPEATED=4.40 10E3/UL; NEUTROPHIL ABS=0.254 10E3/UL /REPEATED=2.07 10E3/UL THERE WAS NO REPORTED IMPACT TO PATIENT MANAGEMENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16753443 ↗
• MalfunctionApr 11, 2023Overheating of Device; Sparking; Overheating of Device; Sparking

  THE CUSTOMER OBSERVED ERROR CODE 1050, ASPIRATION PROBE FAILED TO RETURN TO UPPER POSITION, ON THE CELL-DYN SAPPHIRE ANALYZER. WHILE TROUBLESHOOTING THE ISSUE, UPON PLUGGING IN THE ASPIRATION ASSEMBLY, A SPARK WAS OBSERVED AND A BURNING ODOR WAS PRESENT. FURTHER INVESTIGATION INDICATED THE PRINTED CIRCUIT BOARD (PCB) HAD VISIBLE BURN MARKS. A REPLACEMENT PCB WAS ORDERED. THE CHARRING WAS ISOLATED TO THE PCB. NO FIRE WAS OBSERVED AND NO INJURY OCCURRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16717659 ↗
• MalfunctionFeb 2, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER OBSERVED DISCREPANT HEMOGLOBIN RESULTS GENERATED ON THE CELL-DYN SAPPHIRE ANALYZERS FOR ONE PATIENT. THE CUSTOMER STATED THE SAME SAMPLE WAS USED FOR BOTH ANALYZERS. THE CUSTOMER DOES NOT KNOW WHICH RESULT IS CORRECT. THE FOLLOWING DATA WAS PROVIDED: (B)(6) 2022 SID (B)(6) INITIAL RESULT (42840AZ) = 6.37 G/DL, (B)(6) 2022 SID (B)(6) REPEAT RESULT (60016AZ) = 11.1 G/DL. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16286023 ↗
• MalfunctionFeb 1, 2023Incorrect, Inadequate or Imprecise Result or Readings; Incorrect, Inadequate or Imprecise Result or Readings

  THE CUSTOMER OBSERVED DISCREPANT HEMOGLOBIN RESULTS GENERATED ON THE CELL-DYN SAPPHIRE ANALYZER FOR ONE PATIENT. THE FOLLOWING RESULTS WERE PROVIDED: (B)(6) SID (B)(4) INITIAL RESULT = 6.37 G/DL (B)(6) 2022 SID (B)(4) REPEAT RESULT = 11.1 G/DL NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16276806 ↗
• MalfunctionNov 16, 2022Leak/Splash; Leak/Splash

  THE CUSTOMER WAS SPLASHED WITH A SMALL AMOUNT OF LIQUID IN HER LEFT EYE WHEN PULLING A TUBE OFF THE CELL DYN SAPPHIRE ANALYZER. THE CUSTOMER HAD ALREADY REPLACED THE AERATION PROBE AND EMPTIED THE CONTAINER. THE CUSTOMER WAS NOT WEARING PROTECTIVE EYE WEAR. THE CUSTOMER FLUSHED THE CONTAINER IN WHICH AERATION PROBE IS SEATED AND BACK-FLUSHED THE HGB POT TO RULE OUT THAT IT IS NOT DRAINING. THEN THE CUSTOMER GOT A SMALL AMOUNT OF LIQUID INTO HER LEFT EYE WHILE PULLING OFF TUBING. THE CUSTOMER DID NOT EXPERIENCE ANY BURNING BUT IMMEDIATELY USED THE EYE WASH. THE CUSTOMER VISITED AN OPHTHALMOLOGIST WHO INDICATED THAT THERE WAS MINIMAL CONJUNCTIVAL IRRITATION, NO CHEMICAL BURNS OR MUCOSAL INJURY. THE CUSTOMER RECEIVED EYE DROPS (OPTHAL) TO USE AS NEEDED AND NO FURTHER TREATMENT WAS REQUIRED. NO ADVERSE IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15806889 ↗
• MalfunctionOct 27, 2022Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED DISCREPANCY IN THE CD4T T CELLS RESULTS GENERATED ON THE CELL-DYN SAPPHIRE DURING A CORRELATION STUDY WITH THE REFERENCE LAB. THE FOLLOWING DATA WAS PROVIDED (NORMAL RANGE FOR CD4% IS 30 TO 61%): CORRELATION PERFORMED ON (B)(6) 2022. SID (B)(6). SAPPHIRE CD4% RESULT = 41.9%, LABCORP RESULT = 55.2%. SID (B)(6). SAPPHIRE CD4% RESULT = 22.8%, LABCORP RESULT = 30.7%. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15680121 ↗
• MalfunctionAug 30, 2022Low Test Results; Low Test Results

  THE CUSTOMER OBSERVED FALSELY DEPRESSED WBC RESULTS GENERATED ON THE CELL DYN SAPPHIRE FOR 5 PATIENTS. THE SAMPLES WERE REPEATED ON ANOTHER ANALYZER AND WERE CORRECT. THE CUSTOMER STATED THAT THERE WERE OTHER CELLS PRESENT IN WBC SAMPLE (OBSERVED AFTER MICROSCOPIC INSPECTION). THE FOLLOWING DATA WAS PROVIDED: SID (B)(6) BC 0 E9/L, REPEATED ON THE SAME ANALYZER WBC 2.92 E9/L SID (B)(6) BC 0.005 E9/L, REPEATED ON THE SAME ANALYZER 5.93 E9/L SID (B)(6) BC 0 E9/L, REPEATED ON THE SAME ANALYZER 30 E9/L OTHER SAMPLE IDS WITH WBC VALUE 0 OR NEARLY 0 (NO SPECIFIC VALUES PROVIDED): (B)(6). IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15324447 ↗
• MalfunctionAug 23, 2022Smoking; Smoking

  THE VACUUM ACCUMULATOR OF THE CELL-DYN SAPPHIRE ANALYZER HAD OVERFLOWED AND LEAKED OUT TO THE TABLE AND FLOOR CAUSING THE ABBOTTLINK POWER CORD TO GET WET. VISIBLE SMOKE WAS OBSERVED FROM THE ABBOTTLINK POWER CORD. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT. THE FIELD SERVICE ENGINEER (FSE) INSPECTED THE ANALYZER AND FOUND DRIED VACUUM PUMP WHICH CAUSED THE VACUUM ACCUMULATOR TO OVERFLOW. THE FSE ALSO REPLACED THE POWER CORD FOR THE ABBOTTLINK FIREWALL. NO IMPACT TO PATIENT MANAGEMENT WAS REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15276533 ↗
• InjuryAug 23, 2022Unintended Electrical Shock; Unintended Electrical Shock

  THE VACUUM ACCUMULATOR OF THE CELL-DYN SAPPHIRE ANALYZER HAD OVERFLOWED AND LEAKED OUT TO THE TABLE AND FLOOR. WHILE CLEANING UP THE FLUID, THE LAB ASSISTANT CUSTOMER FELT A SMALL SHOCK. THE CUSTOMER STATED NO MEDICAL TREATMENT WAS NEEDED AND SHE COMPLETED HER SHIFT. THE CUSTOMER WAS WEARING PERSONAL PROTECTIVE EQUIPMENT. THE FIELD SERVICE ENGINEER (FSE) INSPECTED THE ANALYZER AND FOUND DRIED VACUUM PUMP WHICH CAUSED THE VACUUM ACCUMULATOR TO OVERFLOW. NO MEDICAL TREATMENT NEEDED FROM THE ELECTRIC SHOCK.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15276522 ↗
• MalfunctionJul 18, 2022Leak/Splash; Leak/Splash

  THE CUSTOMER REPORTED AN EXPOSURE TO THE FACE WHILE TROUBLE-SHOOTING A CELL-DYN SAPPHIRE ANALYZER. WHILE DISCONNECTING THE TUBING AT V225, THE CUSTOMER WAS SPRAYED IN THE FACE. THE CUSTOMER WAS WEARING APPROPRIATE PERSONAL PROTECTIVE EQUIPMENT (PPE): SAFETY GLASSES, LAB COAT, AND GLOVES. THE CUSTOMER STATED THAT THE LIQUID SPRAYED ON THE SAFETY GLASSES ONLY AND NO MEDICAL ATTENTION WAS SOUGHT. THERE WAS NO INJURY REPORTED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15047592 ↗
• MalfunctionJun 28, 2022Thermal Decomposition of Device; Thermal Decomposition of Device

  THE CUSTOMER STATED THE CELL-DYN SAPPHIRE INSTRUMENT WILL NOT TURN ON. THE CUSTOMER OBSERVED THE POWER CORD CONNECTION POINT ON THE MAIN UNIT APPEARS TO BE BLACKENED AND CHARRED FROM THE PICTURE. THERE WAS NO IMPACT TO PATIENT MANAGEMENT REPORTED. NO INJURIES TO REPORT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 14844477 ↗