Dry Acid Dissolution Unit 160148Recalls & reported problems

Summary

The FDA's MAUDE database contains 21 adverse event reports that list this exact device (DI 00840861101009), received between Jun 22, 2017 and Sep 4, 2026 — classified as 21 malfunctions.

The most frequently reported specific device problem is “Thermal Decomposition of Device” (14 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 21 most recent of 21 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 4, 2026Thermal Decomposition of Device

  A user facility Biomedical Technician (BMT) reported the mixer would not fill. The BMT was advised to remove panel from the front. The BMT found two burnt wires and was advised to replace the entire assembly. Additional information was requested but was not received to date.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50615529 ↗
• MalfunctionDec 24, 2025Thermal Decomposition of Device; Thermal Decomposition of Device

  A BIOMEDICAL TECHNICIAN (BMT) REPORTED THERE WAS NO WATER COMING THROUGH THE JET VALVES OR THE RECIRCULATION VALVE IN DISSOLUTION/RINSE MODES. THE PUMP ASSEMBLY WAS WORKING IN TRANSFER AND DRAIN MODES (NO ISSUES WITH THE PUMP/FLUID MOVEMENT). THE BMT WAS ADVISED TO CHECK FOR ANY CORROSION ISSUES WITH THE WIRING HARNESSES GOING TO THE JET OR RECIRCULATION VALVES UNDER THE TANK (CHECK FOR FLUID LEAKS) OR SWAP THE CONTROL BOARD ASSEMBLY. THERE WAS NO PATIENT INVOLVEMENT OR INJURY NOTED AT INTAKE. UPON FOLLOW-UP, THE BMT STATED THEY REPLACED THE SOLENOID VALVE TO RESOLVE THE REPORTED ISSUE. THE VALVE LOOKED BURNT BUT DID NOT SMELL BURNT. THERE WAS WATER ON THE ELECTRONIC PART OF THE VALVE, WHICH WAS SHORTED. THE MIXER WAS BACK IN SERVICE. NO PHOTOS WERE AVAILABLE. NO PARTS WERE RETURNED FOR EVALUATION. THE BMT WAS UNABLE TO PROVIDE THE SERIAL NUMBER OR LOT NUMBER OF THE PRODUCT(S) REPLACED. IT WAS CONFIRMED THERE WAS NO PATIENT INVOLVEMENT, HARM, OR ADVERSE EVENTS ASSOCIATED WITH THE REPORTED ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23889220 ↗
• MalfunctionSep 11, 2025Unintended Electrical Shock; Unintended Electrical Shock

  THE BIOMEDICAL TECHNICIAN FOR A USER FACILITY REPORTED TO FRESENIUS TECHNICAL SERVICES THAT THE DRY ACID MIXER WAS SKIPPING TO HOMOGENIZE MODE WITHOUT FILING. THE BIOMED MANUALLY FILLED THE MIXER WITH REVERSE OSMOSIS (RO) WATER THROUGH THE TOP PORT TO PREVENT DELAYS IN TREATMENT. THE BIOMED ALSO STATED THAT ANOTHER BIOMED WAS TROUBLESHOOTING THE ISSUE AND ATTEMPTED TO WIPE THE FINAL FILL SENSOR AND RECEIVED AN ELECTRICAL SHOCK. THE BIOMED DID NOT REQUIRE MEDICAL INTERVENTION AS A RESULT OF THIS ISSUE. THE ISSUE HAS NOT REOCCURRED. NO VISUAL INDICATIONS OF THERMAL DECOMPOSITION WERE NOTED WITHIN THE SYSTEM .THE BIOMED STATED THAT THE MIXER WAS LATER TESTED WITH WATER AND FILL WAS NOT SKIPPED. THE BIOMED BELIEVES TURNING THE MIXER OFF AND ON MAY HAVE RESET IT AND RESOLVED THE REPORTED ISSUE. THE BIOMED BELIEVES THE MIXER TO BE WORKING AS INTENDED. NO PART REPLACEMENTS WERE REQUIRED IN ORDER TO RETURN THE MIXER TO FULL SERVICE. NO PARTS WILL BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23030522 ↗
• MalfunctionJul 2, 2025Thermal Decomposition of Device; Thermal Decomposition of Device

  A USER FACILITY'S BIOMEDICAL TECHNICIAN (BMT) REPORTED THAT A FRESENIUS DRY ACID MIXER EMITTED A BURNING SMELL AND STOPPED DURING ¿HOMOGENIZE¿. A FRESENIUS FIELD SERVICE TECHNICIAN (FST) WAS CALLED ONSITE AND FOUND THAT THE JET VALVE CONNECTOR AND WIRE HARNESS WERE CORRODED. THEY REPLACED THE JET VALVE CONNECTOR AND WIRE HARNESS TO RESOLVE THE ISSUE. A PATIENT WAS NOT CONNECTED TO THE MACHINE AT THE TIME OF THE INCIDENT AND THERE WAS NO HARM TO ANY PATIENTS OR INDIVIDUALS BECAUSE OF THIS MALFUNCTION. MULTIPLE ATTEMPTS HAVE BEEN MADE TO CONTACT THE CUSTOMER TO OBTAIN ADDITIONAL INFORMATION RELATED TO THE REPORTED EVENT. AT THIS TIME, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22383223 ↗
• MalfunctionSep 26, 2023Thermal Decomposition of Device; Arcing; Thermal Decomposition of Device; Arcing

  A USER FACILITY AREA TECHNICAL OPERATIONS MANAGER (ATOM) REPORTED TO FRESENIUS TECHNICAL SERVICES THAT THE POWER CORD OF THE DRY ACID MIXER APPEARED SCORCHED. THE INSIDE OF THE POWER PLUG APPEARED BROWN/BLACK. THE MIXER ALSO WILL NOT OPERATE IN DISSOLUTION MODE. THERE IS AN ACTIVE LEAK AROUND THE PUMP ASSEMBLY AND THE PUMP INITIATES BUT HAS VERY NOISY OPERATION. THERE IS ALSO RUST PRESENT ON THE FRAME. A REPLACEMENT DRY ACID MIXER WAS REQUESTED. ADDITIONAL INFORMATION WAS OBTAINED DURING FOLLOW-UP. THE ATOM CONFIRMED THAT THE POWER PLUG ON THE FRESENIUS DRY ACID MIXER WAS BURNED. THE CLEAR PLASTIC AT THE END OF THE PLUG APPEARED BROWN AND THE PRONGS HAD BUBBLED AND ONE PRONG WAS CORRODED. THERE WAS NO BURNING SMELL, MELTING, SMOKE, SPARK, OR FLAME OBSERVED. THE MACHINE IS PLUGGED INTO A HOSPITAL GRADE GROUND-FAULT CIRCUIT INTERRUPTER (GFCI) OUTLET. THE ATOM CONFIRMED THAT THE POWER OUTLET WAS ALSO BROWN. THE OUTLET WAS CHECKED WITH NO OPERATIONAL IRREGULARITIES FOUND AND MEASURED AT 119 VOLTS. THE ATOM NOTED THAT CONDENSATION WAS OBSERVED AROUND THE WATERPROOF CAGE. ADDITIONALLY, THE ATOM CONFIRMED AN ISSUE WITH THE PUMP WHERE IT STARTS BUT DOES NOT OPERATE. THE ATOM NOTED THAT THE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17818616 ↗
• MalfunctionAug 16, 2023Smoking; Smoking

  A USER FACILITY BIOMEDICAL TECHNICIAN (BMT) REPORTED DURING DISSOLUTION MODE AND AFTER MIXING THERE WERE BLACK SPECKS IN THE GRANFLO CONCENTRATE AND ONLY TWO JETS WERE WORKING. THE BMT REPORTED SMOKE WAS SEEN IN THE TANK. THE BMT WAS ADVISED TO CHECK THE PUMP HEAD TO SEE IF IT FAILED AND TO CHECK UNDER THE MACHINE TO SEE IF ANY OF THE VALVES HAD BEEN LEAKED ON AND CHECK THE ELECTRONICS FOR FAILED COMPONENTS. UPON FOLLOW-UP, THE BMT STATED THE SMOKE WAS OBSERVED IN THE TANK AND CONFIRMED THERE WAS NO BURNT COMPONENTS, SPARK OR FLAME NOTED AS A RESULT OF THE REPORTED EVENT. THE BMT STATED THE POWER SUPPLY AND ALL COMPONENTS WERE EXAMINED AND NO THERMAL DAMAGE WAS NOTED. THERE WAS NO PATIENT INVOLVEMENT, PATIENT HARM, OR ADVERSE EVENT REPORTED. THE MIXER REMAINS OUT OF SERVICE PENDING RECEIPT AND REPLACEMENT OF PUMP ASSEMBLY AND JET VALVE. IT WAS REPORTED THE REPLACED COMPONENTS WERE NO LONGER AVAILABLE FOR INVESTIGATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 17558386 ↗
• MalfunctionAug 10, 2022Smoking; Smoking

  A BIOMEDICAL TECHNICIAN (BIOMED) AT A USER FACILITY REPORTED THAT SMOKE WAS COMING FROM A FRESENIUS DRY ACID MIXER. THE MACHINE WAS REMOVED FROM SERVICE. THE CUSTOMER REQUESTED AN ONSITE EVALUATION BY A FRESENIUS FIELD SERVICE TECHNICIAN (FST) HOWEVER THIS REQUEST WAS CANCELLED THE FOLLOWING DAY. THERE WAS NO REPORTED HARM TO ANY PATIENTS OR INDIVIDUALS BECAUSE OF THIS MALFUNCTION. ADDITIONAL INFORMATION WAS REQUESTED, HOWEVER A RESPONSE HAS NOT BEEN RECEIVED. NO PARTS WERE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15200827 ↗
• MalfunctionDec 17, 2021Thermal Decomposition of Device; Thermal Decomposition of Device

  A BIOMEDICAL TECHNICIAN (BMT) REPORTED A DRY ACID MIXER WAS NOT FILLING WITH NO POWER TO THE PUMP. IT WAS NOTED THERE WERE BURNED FUSES (F1/F2) AND A FLUID LEAK FROM THE HYDRAULICS. THE MACHINE WAS UNABLE TO BE REPAIRED AND THE BMT WAS ADVISED TO PURCHASE A NEW MIXER. THERE WAS NO PATIENT INVOLVEMENT AND NO PATIENT INJURY. ADDITIONAL INFORMATION RECEIVED VIA EMAIL. THE BMT STATED THE ISSUE WAS ATTRIBUTED TO WEAR AND TEAR. THE PUMP WAS NOT REPLACED AND THERE WAS NO ISSUE WITH THE PUMP. THE ISSUE WAS ATTRIBUTED TO BLOWN FUSES AND THERE WERE NO OTHER NOTED BURNED COMPONENTS. THE BMT STATED THERE WAS NO ISSUE WITH THE PUMP AND NO HYDRAULIC LEAK. THE UNIT WAS REPAIRED. THE HOURS ON THE UNIT MIXER WAS NOT ABLE TO BE PROVIDED. PER BMT THE POWER SUPPLY BOARD WAS PURCHASED AND INSTALLED ON THE MIXER BY THE BMT TEAM IN THE AREA. THE MACHINE WAS PLACED BACK IN SERVICE WITHOUT ISSUE. NO ADDITIONAL INFORMATION WAS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 13029055 ↗
• MalfunctionNov 24, 2021Thermal Decomposition of Device; Thermal Decomposition of Device

  A FRESENIUS FIELD SERVICE TECHNICIAN (FST) REPORTED THAT A FRESENIUS DRY ACID MIXER AT A USER FACILITY HAD A BURNED DISPLAY BOARD AND A BURNED PUMP. THE FST WAS CALLED ONSITE BY THE USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) AFTER THE DRY ACID MIXER WOULD NOT TRANSFER. THE FST FOUND THAT THE PUMP WAS WIRED BY THE CUSTOMER INCORRECTLY WHICH BURNED THE PUMP. THE DISPLAY BOARD, PUMP, AND CPU CHIP WERE REPLACED TO RESOLVE THE REPORTED ISSUE. THERE WAS NO HARM TO ANY PATIENTS OR INDIVIDUALS BECAUSE OF THIS MALFUNCTION. ADDITIONAL INFORMATION WAS REQUESTED, HOWEVER A RESPONSE WAS NOT RECEIVED. THE COMPLAINT SAMPLES WERE NOT RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12869883 ↗
• MalfunctionNov 16, 2021Melted; Melted

  A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED A SEIZED MIXING PUMP. A FRESENIUS FST (FIELD SERVICE TECHNICIAN) WAS CALLED ON-SITE TO REPAIR A DRY ACID MIXER THAT WAS RECIRCULATING WHICH CAUSED THE MIXING PUMP TO SEIZE DUE TO EXCESSIVE HEAT. THE PUMP HAD SEVERE HEAT DAMAGE AND HAD MELTED AS A RESULT OF THE SEIZING. THE PUMP WAS THE ORIGINAL FRESENIUS PART ON THE MACHINE. THE FST REPORTED THAT THERE WAS NO DAMAGE OBSERVED ON ANY OTHER COMPONENTS, OR ANY OTHER ADDITIONAL ISSUES, ASSOCIATED WITH THE MELTED PUMP. THE FST STATED THAT THERE WAS NO OBSERVED BURNING SMELL, SMOKE, SPARK, FLAME, ARCING, OR ANY OTHER VISIBLE HEAT OR ELECTRICAL DAMAGE RELATED TO THE MELTING FOUND ON THE PUMP. THE FST WAS ABLE TO REMOVE THE SHAVINGS THAT WERE HOLDING THE PUMP SHAFT SO THEY COULD USE THE MIXER SAFELY. THE PUMP MOTOR WAS REPLACED TO RESOLVE THE REPORTED ISSUE. THE MIXER IS WORKING PROPERLY AT THIS TIME. FUNCTIONAL TESTS WERE COMPLETED SUCCESSFULLY. THERE WAS NO PATIENT INVOLVEMENT OR HARM TO ANY INDIVIDUALS BECAUSE OF THIS MALFUNCTION. THE FST CONFIRMED THAT THE ORIGINAL PUMP MOTOR IS AT THE USER FACILITY AND IS AVAILABLE TO BE RETURNED FOR PHYSICAL EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12822219 ↗
• MalfunctionNov 8, 2021Thermal Decomposition of Device; Thermal Decomposition of Device

  A BIOMEDICAL TECHNICIAN (BIOMED) AT A USER FACILITY REPORTED THAT A FRESENIUS HEMODIALYSIS (HD) DRY ACID MIXER HAD A MOTOR THAT WAS NOT MIXING. THE FIELD SERVICE TECHNICIAN (FST) FOUND A PUMP HEAD THAT WAS BURNED OUT. THE BURNED PUMP HEAD WAS INITIALLY NOTICED DURING MACHINE REPAIR FOR THE MIXER IMPROPERLY DETECTING WATER INSIDE. THE BIOMED DID NOT OBSERVE ANY BURNING SMELL, SMOKE, SPARK, FLAME, ARCING, OR ANY OTHER VISIBLE HEAT OR ELECTRICAL DAMAGE RELATED TO THE BURNING FOUND ON THE PUMP HEAD. THERE WAS NO HARM TO ANY PATIENTS OR INDIVIDUALS BECAUSE OF THIS MALFUNCTION. THE BIOMED REPORTED THAT THE PUMP IS THE ORIGINAL FRESENIUS PART ON THE MACHINE AND THAT THERE WAS NO DAMAGE OBSERVED ON ANY OTHER COMPONENTS ASSOCIATED WITH THE BURNED PUMP HEAD. THE BIOMED REPLACED THE DRY LEVEL SENSOR AND PUMP, WHICH RESOLVED THE ISSUE. THE UNIT WAS RETURNED TO SERVICE AT THE USER FACILITY WITHOUT ISSUE AND WITHOUT REOCCURRENCE OF THE EVENT. THE PUMP IS AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12770114 ↗
• MalfunctionAug 31, 2021Thermal Decomposition of Device; Thermal Decomposition of Device

  A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) CONTACTED FRESENIUS TECHNICAL SUPPORT (TS) FOR ASSISTANCE WITH A DRY ACID 99 GALLON MIXER THAT WAS EXPERIENCING ISSUES. THE BIOMED REPORTED THAT THE MOTOR WAS NOT TURNING ON DURING RINSE MODE. AFTER SOME TROUBLESHOOTING, IT WAS BELIEVED THAT THE MIXER WOULD NOT FILL WITH WATER. THE BIOMED REPLACED THE CENTRAL PROCESSING UNIT (CPU), CONTROL BOARD, AND POWER SUPPLY, BUT THIS DID NOT RESOLVE THE ISSUE. THE BIOMED ORDERED A NEW FILL VALVE AND ANTICIPATES THAT REPLACING THIS PART WILL RESOLVE THE ISSUE. AT THE TIME OF FOLLOW-UP, THE BIOMED WAS STILL WAITING ON THE FILL VALVE TO ARRIVE. WHEN THE BIOMED REPLACED THE POWER SUPPLY, THEY NOTICED THAT IT SEEMED TO BE OVERHEATING ONCE THEY STARTED RUNNING THE MIXER TO GET THE MOTOR TO TURN ON. THE BIOMED GOT A CLOSER LOOK AT THE POWER SUPPLY AND NOTICED THAT ONE OF THE FUSES LOOKED TO HAVE BEEN CHARRED. THE CHARRING WAS BELIEVED TO BE CAUSED BY HEAT DAMAGE. THE BIOMED CONFIRMED THERE WAS NO PATIENT INVOLVEMENT ASSOCIATED WITH THE REPORTED EVENT. MULTIPLE ATTEMPTS HAVE BEEN MADE OBTAIN ADDITIONAL EVENT DETAILS, AND THUS FAR, NO FURTHER INFORMATION HAS BEEN PROVIDED. THE SAMPLE IS NOT EXPECTED TO BE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12393005 ↗
• MalfunctionOct 3, 2020Thermal Decomposition of Device; Fluid/Blood Leak; Smoking; Thermal Decomposition of Device; Fluid/Blood Leak; Smoking

  A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) CONTACTED FRESENIUS TECHNICAL SUPPORT (TS) TO REPORT A BURNING SMELL COMING FROM A 99 GALLON DRY ACID MIXER. THE BIOMED STATED THE SMELL WAS COMING FROM THE RECIRCULATION PUMP ASSEMBLY DURING DISSOLUTION MODE. THE BURNING SMELL WAS REPORTEDLY ACCOMPANIED BY SMOKE. MORE DETAILS WERE OBTAINED THROUGH FOLLOW-UP WITH THE BIOMED. THE BIOMED CONFIRMED THERE WAS A BURNING SMELL AND SMOKE COMING FROM THE MIXER. ALTHOUGH INITIALLY THOUGHT TO BE COMING FROM THE RECIRCULATION PUMP ASSEMBLY, UPON FURTHER INVESTIGATION IT WAS FOUND TO BE COMING FROM ELSEWHERE. THE BIOMED HAD ALREADY ORDERED A REPLACEMENT RECIRCULATION PUMP ASSEMBLY FROM TS. AT A LATER (UNSPECIFIED) DATE, THE BURNING SMELL WAS NOTED AGAIN. THE BIOMED IMMEDIATELY UNPLUGGED THE POWER CORD, WHICH PREVENTED THE MIXER FROM SMOKING AGAIN. AFTER FURTHER EVALUATION, THE BIOMED REALIZED SOMETHING WAS DRIPPING FROM ABOVE THE PUMP ASSEMBLY. ONE OF THE FOUR JET (SOLENOID) VALVES WAS LEAKING, AND IT LEAKED ONTO A WIRING HARNESS BELOW THE VALVE. THE BIOMED REPORTED THAT THE BURNING SMELL WAS COMING FROM THIS WIRING HARNESS. THE COMPONENT DISPLAYED EVIDENCE OF CORROSION AND BURN DAMAGE. PHOTOGRAPH

  Patient problems: No Patient Involvement

  MAUDE report 10624159 ↗
• MalfunctionJul 29, 2020Thermal Decomposition of Device; Thermal Decomposition of Device

  A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED THAT A (B)(6) DRY ACID UNIT MIXER WOULD NOT FILL IN DISSOLUTION/RINSE MODES. IT WAS REPORTED THAT THERE WAS A SMOKE SMELL AND NOTHING BESIDES THE PUMP ASSEMBLY WAS WORKING. IT WAS REPORTED THAT THE POWER CORD LOOKED LIKE IT WAS BURNED ON THE INSIDE. THE PLUG WAS REPLACED AND THE ISSUE STILL OCCURRED. UPON FOLLOW-UP, THE BIOMED CONFIRMED THAT THE POWER PLUG WAS BURNED. THERE WAS A BURNING SMELL, HOWEVER, NO INDICATION OF MELTING, SMOKE, SPARK, OR FLAME, ONLY THAT WHEN REMOVED FROM THE OUTLET, THE PLUG APPEARED TO BE DISCOLORED AND BURNED. THE BURN DAMAGE WAS NOTICED DURING REGULAR MACHINE SETUP. THE MACHINE HOURS WERE UNKNOWN. THE MACHINE HAD NO PREVIOUS PROBLEMS WITH FAILING THE ELECTRICAL LEAKAGE TEST OR ANY OTHER DAMAGED COMPONENT ASSOCIATED WITH THE DAMAGED PLUG. THE BIOMED STATED THAT THE MACHINE IS PLUGGED INTO A HOSPITAL GRADE GROUND-FAULT CIRCUIT INTERRUPTER (GFCI) OUTLET. THE BIOMED STATED THAT THE PLUG HAS BEEN REPLACED AND THE MACHINE IS BACK IN SERVICE WITHOUT REOCCURRENCE OF THE REPORTED EVENT. THE BIOMED CONFIRMED A PATIENT WAS NOT CONNECTED TO THE MACHINE AT THE TIME OF THE INCIDENT AND THERE WAS NO HARM TO ANY P

  Patient problems: No Patient Involvement

  MAUDE report 10339168 ↗
• MalfunctionNov 11, 2019Thermal Decomposition of Device; Thermal Decomposition of Device

  A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED THAT THE PUMP ON THE FRESENIUS DRY ACID MIX WAS BURNED. THE BIOMED REPLACED THE DRY SENSOR, MID-LEVEL SENSOR, CONTROL BOARD ASSEMBLY, PROGRAMMED CPU AND PUMP ASSEMBLY. THERE WAS NO MELTING, BURNING SMELL, SMOKE, SPARK, FLAME, OR ARCING OBSERVED. THERE WAS NO PATIENT INVOLVEMENT. THE MACHINE HAS APPROXIMATELY 600 HOURS. THE MACHINE HAS NOT HAD ANY PAST PROBLEMS WITH FAILING THE ELECTRICAL LEAKAGE TEST OR ANY OTHER DAMAGED COMPONENTS. THE MACHINE IS PLUGGED INTO A HOSPITAL GRADE GROUND-FAULT CIRCUIT INTERRUPTER (GFCI) OUTLET. THE MACHINE IS BACK IN SERVICE WITHOUT REOCCURRENCE OF THE REPORTED EVENT. THE COMPLAINT DEVICE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION

  Patient problems: No Patient Involvement

  MAUDE report 9304473 ↗
• MalfunctionNov 4, 2019Melted; Melted

  A USER FACILITY BIOMED TECHNICIAN REPORTED THAT A DRY ACID 99 GALLON UNIT WAS NOT DISSOLVING POWDER. THE TECHNICIAN STATED THE PUMP THEY INSTALLED HAD GOTTEN SO HOT THAT IT MELTED WHEN TRYING TO DISSOLVE THE POWDER. THE TECHNICIAN HAD REQUESTED A NEW PUMP AND MOTOR TO REPLACE THE UNIT. AFTER INSTALLING THE NEW SET, THEY RECEIVED, THE MACHINE DISSOLVED THE POWDER ACCORDINGLY. THE MACHINE IS BACK IN SERVICE. THERE WAS NO PATIENT INVOLVEMENT. THE COMPLAINT DEVICE WAS DISCARDED AND NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. ADDITIONAL INFORMATION WAS REQUESTED, HOWEVER, TO DATE NOT PROVIDED.

  Patient problems: No Patient Involvement

  MAUDE report 9272364 ↗
• MalfunctionMay 29, 2019Melted; Melted

  A BIOMEDICAL TECHNICIAN (BIOMED) AT A USER FACILITY REPORTED THAT A FRESENIUS 2008K DRY ACID 99 GALLON UNIT MACHINE HAD A VISIBLY MELTED PUMP ASSEMBLY HOUSING. THE PLASTIC HOUSING ON THE PUMP ASSEMBLY WAS MELTED AND REPORTEDLY GAVE OFF A BURNED PLASTIC SMELL. THE MELTED HOUSING WAS FOUND WHEN THE BIOMED WAS SERVICING THE MACHINE FOR STAYING IN DRAIN MODE, WHICH RAN THE PUMP DRY AND OVERHEATED THE PUMP HOUSING. A PATIENT WAS NOT CONNECTED TO THE MACHINE AT THE TIME OF THE INCIDENT AND THERE WAS NO HARM TO ANY PATIENTS OR INDIVIDUALS BECAUSE OF THIS MALFUNCTION. THE PUMP HOUSING WAS THE ORIGINAL FRESENIUS PART ON THE MACHINE. THE BIOMED REPORTED THAT THERE WAS NO DAMAGE OBSERVED ON ANY OTHER COMPONENTS, OR ANY OTHER ADDITIONAL ISSUES, ASSOCIATED WITH THE BURNED AND MELTED DISTRIBUTION BOARD. THE BIOMED CONFIRMED THERE WAS NO OBSERVED SMOKE, SPARK, FLAME, OR ARCING DUE TO THE ISSUE. THE BIOMED REPLACED THE PUMP ASSEMBLY AND PUMP DRY SENSOR, WHICH RESOLVED THE ISSUE. THE UNIT WAS RETURNED TO SERVICE AT THE USER FACILITY WITHOUT ISSUE AND WITHOUT REOCCURRENCE OF THE EVENT. THE WAS REPORTEDLY AVAILABLE AND WOULD BE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.

  Patient problems: No Patient Involvement

  MAUDE report 8649731 ↗
• MalfunctionSep 26, 2017Thermal Decomposition of Device; Fire; Thermal Decomposition of Device; Fire

  A FIELD SERVICE MANAGER REPORTED THE CLINIC WAS MIXING A BATCH OF ACID AND THE RECIRCULATION MOTOR CAUGHT FIRE. THE FIRE WAS PUT OUT WITH A FIRE EXTINGUISHER AND STRUCTURAL DAMAGE TO THE TANK WAS NOTED. ADDITIONAL FOLLOW-UP WAS MADE WITH THE CLINIC MANAGER, WHO CONFIRMED THERE WAS NO PATIENT INVOLVEMENT AND NO HARM OR ADVERSE EVENT OCCURRED AS A RESULT OF THE REPORTED ISSUE. NO ADDITIONAL COMPONENTS WERE DAMAGED, AND EMERGENCY SERVICES WERE NOT NEEDED. PER CLINIC MANAGER IT WAS UNKNOWN WHAT MAY HAVE ATTRIBUTED TO THE REPORTED ISSUE WITH THE RECIRCULATION MOTOR. THE CLINIC MANAGER CONFIRMED THAT HOSPITAL GRADE GROUND-FAULT CIRCUIT INTERRUPTER (GFCI) OUTLETS WERE USED. THE PREVIOUS MIXER REMAINED OUT OF SERVICE SINCE AND NO SAMPLE WAS AVAILABLE TO BE RETURNED FOR EVALUATION.

  Patient problems: No Patient Involvement

  MAUDE report 6895493 ↗
• MalfunctionSep 21, 2017Overheating of Device; Overheating of Device

  A FACILITY TECHNICIAN REPORTED A SOLENOID VALVE AND HARNESS WERE DAMAGE DUE TO BURNT VALVE AND HARNESS CONNECTOR. THE TECHNICIAN REPORTED HE DID NOT SEE FIRE OR SMOKE. THE MIXER WAS NOT OPERATIONAL. DURING FOLLOW UP ANOTHER FACILITY CONTACT REPORTED THERE WAS NO INJURY ASSOCIATED WITH THE EVENT AND NO PATIENT INVOLVEMENT. THE MIXER WAS REPAIRED ON SITE.

  Patient problems: No Patient Involvement

  MAUDE report 6885015 ↗
• MalfunctionSep 20, 2017Thermal Decomposition of Device; Melted; Thermal Decomposition of Device; Melted

  A BIOMEDICAL TECHNICIAN (BIOMED) AT THE USER FACILITY REPORTED THAT A DRY ACID II MIXER MACHINE HAD JETS THAT WERE NOT WORKING. NO PATIENT WAS CONNECTED TO THE MACHINE AT THE TIME OF THE INCIDENT. THEREFORE, NO PATIENT WAS INVOLVED. THE BIOMED PERFORMED A VISUAL INSPECTION AND NOTED A BLACK SPOT ON ONE OF THE JET VALVES THAT WAS BURNED. ADDITIONALLY, THE PRONG ON THE JET VALVE WAS MELTED. THE CURRENT REPAIR STATUS OF THE MACHINE IS UNKNOWN AND IT IS NOT KNOWN IF THE UNIT HAS BEEN RETURNED TO SERVICE AT THE USER FACILITY. NO PARTS WERE AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Patient Involvement

  MAUDE report 6878374 ↗
• MalfunctionJun 22, 2017Thermal Decomposition of Device; Thermal Decomposition of Device

  A BIOMEDICAL TECHNICIAN AT THE USER FACILITY REPORTED THAT A DRY ACID 99 MACHINE HAS A BURNT WIRING HARNESS CONNECTED TO ONE OF THE VALVES. NO PATIENT WAS CONNECTED TO THE MACHINE AT THE TIME OF THE INCIDENT. THEREFORE, NO PATIENT WAS INVOLVED. THE CURRENT REPAIR STATUS OF THE UNIT IS NOT KNOWN. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT HAS NOT BEEN MADE AVAILABLE. NO PARTS WERE AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Patient Involvement

  MAUDE report 6661385 ↗