Dry Acid Dissolution Unit 160147Recalls & reported problems

Summary

The FDA's MAUDE database contains 129 adverse event reports that list this exact device (DI 00840861100996), received between Dec 13, 2017 and Feb 5, 2026 — classified as 129 malfunctions.

The most frequently reported specific device problem is “Thermal Decomposition of Device” (88 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. What reports can and can't tell you · How this data works · Data updated Oct 16, 2026.

Most reported problems

Recent adverse event reports

The 25 most recent of 129 reports, in the reporter's own words as published by the FDA.

• MalfunctionFeb 5, 2026Thermal Decomposition of Device

  A USER FACILITY'S BIOMEDICAL TECHNICIAN (BMT) REPORTED THAT A DRY ACID 132 GALLON UNIT WAS NOT TRANSFERRING, AND THE PUMP WAS NOT RUNNING. UPON FOLLOW UP, THE BMT SAID THAT THE TRANSFER MOTOR SHOWED SIGNS OF THERMAL DECOMPOSITION AS THE WHITE PLASTIC PROPELLER COMPONENT WAS MELTED AND FUSED TO THE OUTER HOUSING. THE BMT REPORTED THAT THERE WAS NO BURNING SMELL, SMOKE, SPARK, FLAME, OR ARCING OBSERVED. THE BMT REPORTED THAT THERE WAS NO DAMAGE OBSERVED ON ANY OTHER COMPONENTS. THE BMT SAID THAT HE REPLACED THE PROPELLER ON THE TRANSFER MOTOR TO RESOLVE THE ISSUE. THE MIXER HAS BEEN RETURNED TO SERVICE. 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 COMPLAINT SAMPLE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24269123 ↗
• MalfunctionOct 1, 2025Thermal Decomposition of Device; Thermal Decomposition of Device

  A USER FACILITY'S BIOMEDICAL TECHNICIAN (BMT) REPORTED THAT A FRESENIUS DRY ACID MIXER WAS NOT FILLING AND HAD SMOKE COMING FROM THE HYDRAULIC ASSEMBLY IN DISSOLUTION MODE. DURING FOLLOW UP, THE BMT SAID THAT THE COMPONENT WAS CHARRED. THEY ALSO SAID THAT THERE WAS ARCING, SPARK AND SMOKE. THE BMT REPORTED THAT THERE WAS NO MELTING OR FLAME OBSERVED. THE SMOKE DETECTORS DID NOT GO OFF AS HE OPENED THE DOOR TO LET AIR CIRCULATE. 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 HYDRAULIC ASSEMBLY WAS THE ORIGINAL FRESENIUS PART ON THE MACHINE. THE BMT REPORTED THAT THERE WAS DAMAGE (CHARRING) OBSERVED ON THE FILL VALVE, SURGE PROTECTOR AND THE MAIN BOARD AS A RESULT OF THIS ISSUE. THE MIXER IS PLUGGED INTO A HOSPITAL GRADE GROUND-FAULT CIRCUIT INTERRUPTER (GFCI) OUTLET. THE BMT REPLACED THE FILL VALVE, MAIN BOARD AND SURGE PROTECTOR, WHICH RESOLVED THE ISSUE. THE BMT REPORTED THAT THE MACHINE HAS BEEN RETURNED TO SERVICE WITHOUT ISSUE. NO SAMPLES ARE AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. NO PHOTOS ARE AVAILABLE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23190403 ↗
• MalfunctionAug 21, 2025Thermal Decomposition of Device; Thermal Decomposition of Device

  A USER FACILITY'S BIOMEDICAL TECHNICIAN (BMT) REPORTED THAT A FRESENIUS DRY ACID MIXER EMITTED SMOKE AND SPARKS FROM A CRACK IN THE FILL VALVE WHEN POWERED ON. 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 FILL VALVE WAS THE ORIGINAL FRESENIUS PART ON THE MIXER. THE BMT REPORTED THAT THERE WAS NO FLAME, OR ARCING OBSERVED. THE BMT REPORTED THAT THERE WAS NO DAMAGE OBSERVED ON ANY OTHER COMPONENTS. THE MIXER IS PLUGGED INTO A HOSPITAL GRADE GROUND-FAULT CIRCUIT INTERRUPTER (GFCI) OUTLET. THE BMT REPLACED THE FILL VALVE AND CABLE, WHICH RESOLVED THE ISSUE. THE BMT REPORTED THAT THE MACHINE HAS BEEN RETURNED TO SERVICE WITHOUT ISSUE. THE COMPLAINT SAMPLE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22861530 ↗
• MalfunctionJul 22, 2025Thermal Decomposition of Device; Thermal Decomposition of Device

  A BIOMEDICAL TECHNICIAN (BMT) REPORTED TO TECHNICAL SUPPORT THAT A DRY ACID 132 GALLON UNIT, ASSY TO SHIP HAD A LEAKING FILL VALVE THAT WAS RECEIVED RECENTLY. THE BMT TOOK THE O-RING OUT OF THE OLD FILL VALVE AND PUT IT IN THE NEW FILL VALVE AND IT IS NOT LEAKING. THE O-RING HE TOOK OUT WAS SCORED. THE BMT REPORTED THAT HE DID NOT WANT THE PART REPLACED. UPON FOLLOW UP, THE BMT STATED THAT HE REPLACED THE INLET SOLENOID TO RESOLVE THE REPORTED ISSUE. THE BMT NOTED THAT THE O-RING INSIDE THE SOLENOID HAD BURNED OUT. THE MACHINE IS BACK IN SERVICE. NO PARTS WERE RETURNED FOR EVALUATION, AND NO PHOTOS ARE AVAILABLE. THE PART AND LOT NUMBERS OF THE REPLACED COMPONENT COULD NOT BE PROVIDED AT THE TIME OF THE CALL. IT WAS CONFIRMED THAT THERE WAS NO PATIENT INVOLVEMENT, HARM, OR ADVERSE EVENTS ASSOCIATED WITH THE REPORTED ISSUE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 22571815 ↗
• MalfunctionApr 23, 2025Thermal Decomposition of Device; Melted; Thermal Decomposition of Device; Melted

  AN AREA TECHNICAL OPERATIONS MANAGER (ATOM) REPORTED FINDING THERMAL DAMAGE ON THE FILL VALVE OF A DRY ACID 132 GALLON UNIT MIXER AT A HEMODIALYSIS (HD) CLINIC. THE ORIGINAL ISSUE WAS THAT THE MIXER WAS EXPERIENCING POWER ISSUES WHILE BEING USED. THERE WAS ALSO A MILD BURNING SMELL NOTED. AFTER SOME INVESTIGATION, THE ATOM IDENTIFIED THERMAL DAMAGE ON THE FILL VALVE AND THE CONNECTOR OF THE FILL VALVE CABLE. THE COMPONENTS DISPLAYED EVIDENCE OF MELTING AND THERMAL DECOMPOSITION. THE ATOM REPLACED THE FILL VALVE AND FILL VALVE CABLE WITH NEW PARTS. AFTERWARDS, THE MIXER BEGAN EXPERIENCING ANOTHER ISSUE WHERE THE FILL VALVE WOULD NOT CLOSE CAUSING THE MIXER TO OVERFLOW. THE ATOM WAS UNSURE IF THE NEW FILL VALVE WAS BAD, OR IF THERE WAS AN ISSUE WITH THE CONTROL BOARD. TO FURTHER TROUBLESHOOT, THE ATOM BORROWED THE CONTROL BOARD FROM A MIXER AT A DIFFERENT CLINIC. WITH THIS OTHER CONTROL BOARD, THE ATOM SAID THE FILL VALVE WAS CLOSING. AFTER DETERMINING THAT THE CONTROL BOARD HAD TO BE REPLACED AS WELL, THE ATOM ORDERED A NEW ONE. THE CONTROL BOARD WAS REPLACED AND THE MACHINE WAS CONFIRMED TO BE FULLY OPERATIONAL AGAIN. THE ATOM CONFIRMED THERE WERE NO SIGNS OF ANY SMOKE, SPARKS, OR

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21896365 ↗
• MalfunctionMar 18, 2025Thermal Decomposition of Device; Thermal Decomposition of Device

  A USER FACILITY'S BIOMEDICAL TECHNICIAN (BMT) REPORTED THAT A DRY ACID MIXER WOULD NOT RINSE DURING RISE MODE, WOULD NOT FILL AND SMOKE WAS COMING OUT FROM UNDER THE FRONT PANEL. A PATIENT WAS NOT INVOLVED AND THERE WAS NO HARM TO ANY INDIVIDUALS BECAUSE OF THIS MALFUNCTION. THE FRONT PANEL WAS THE ORIGINAL FRESENIUS PART ON THE MACHINE. THE BMT REPORTED THAT THERE WAS NO MELTING, BURNING SMELL, SPARK, FLAME, OR ARCING OBSERVED. THE BMT REPORTED THAT THERE WAS NO DAMAGE OBSERVED ON ANY OTHER COMPONENTS. THE MIXER IS PLUGGED INTO A HOSPITAL GRADE GROUND-FAULT CIRCUIT INTERRUPTER (GFCI) OUTLET. THE BMT REPORTED THAT THE MIXER HAS NOT YET BEEN RETURNED TO SERVICE AS HE IS WAITING FOR PARTS TO ARRIVE. NO SAMPLE IS AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21632041 ↗
• MalfunctionMar 17, 2025Thermal Decomposition of Device; Smoking; Thermal Decomposition of Device; Smoking

  A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO FRESENIUS TECHNICAL SERVICES THAT SMOKE WAS COMING FROM THE DRY ACID MIXER AND IT WOULD NO LONGER FILL DURING DISSOLUTION AND RINSE MODES. A BURN MARK WAS NOTED ON THE CABINET OF THE UNIT BY THE DRAIN VALVE. THE BIOMED WAS ADVISED TO SWAP THE CONTROL BOARD AND SOFTWARE ALONG WITH THE DRAIN VALVE IF BURN/SCORCH MARKS WERE NOTED ON IT. ADDITIONAL INFORMATION WAS OBTAINED DURING FOLLOW-UP WITH ANOTHER FACILITY BIOMED. THERE WAS NO HARM TO ANY PATIENTS OR INDIVIDUALS AS A RESULT OF THIS MALFUNCTION. THE MIXER WAS UNPLUGGED TO EXTINGUISH THE SMOKE. IT WAS CONFIRMED THAT THE SMOKE DID NOT TRIGGER ANY SMOKE DETECTORS WITHIN THE FACILITY. USE OF A FIRE EXTINGUISHER WAS NOT REQUIRED. A BURNING SMELL WAS NOTED UPON REMOVING THE COVER. IT WAS DISCOVERED THAT THE BLACK BOX (THE DRAIN VALVE) THAT CONTROLS THE FILL FUNCTION (NEXT TO THE BLUE BOX) AND A CONNECTED WIRE WERE BURNED. THE PARTS WERE REPLACED TO RESOLVE THE REPORTED ISSUE. NO OTHER PARTS SUSTAINED THERMAL DAMAGE AND NO OTHER ISSUES WERE IDENTIFIED WITHIN THE SYSTEM. THE DRY ACID MIXER WAS RETURNED TO SERVICE FOLLOWING REPAIR. NO PHOTOGRAPHS ARE AVAILABLE FOR REVIEW. NO PARTS A

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21621852 ↗
• MalfunctionJan 16, 2025Thermal Decomposition of Device; Thermal Decomposition of Device

  A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED FINDING THERMAL DAMAGE ON A DRY ACID (132 GALLON UNIT) MIXER. THE BIOMED INITIALLY CONTACTED TECHNICAL SUPPORT (TS) BECAUSE THE MIXER WAS NOT FILLING AND THEY NOTICED A BURNING SMELL COMING FROM THE UNIT. THE BIOMED TRACED THE BURNING SMELL TO THE SOLENOID FILL VALVE WHICH DISPLAYED EVIDENCE OF CHARRING. NO OTHER PARTS SHOWED SIGNS OF THERMAL DAMAGE. THERE WERE NO SIGNS OF ANY SMOKE, SPARKS, OR FLAMES. THE BIOMED SAID THE CONTROL/DISPLAY BOARD ADJACENT TO THE FILL VALVE WAS ALSO AFFECTED. TO RESOLVE THE REPORTED ISSUE, THE BIOMED REPLACED THE BURNT FILL VALVE AND THE CONTROL BOARD. FOLLOWING THE REPAIR, THE BIOMED SAID THE MIXER BEGAN EXPERIENCING ISSUES DURING POWER-UP. THE BIOMED CALLED TS BACK BECAUSE THE MIXER WASN¿T POWERING ON PROPERLY. THE BIOMED WAS INFORMED THAT THE SOFTWARE FROM THE OLD CONTROL BOARD HAD TO BE SWAPPED TO THE NEW BOARD. THE BIOMED DID THIS AND THE MACHINE BECAME FULLY OPERATIONAL AGAIN. THE REPORTED ISSUE DID NOT NEGATIVELY IMPACT ANY TREATMENTS. THE BIOMED SAID THEY HAD ENOUGH ACID MIXED TO CONTINUE OPERATIONS WITHOUT DISRUPTION. NO SAMPLE WAS AVAILABLE FOR EVALUATION; THE BIOMED SAID BOTH THE VALVE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21175233 ↗
• MalfunctionJan 16, 2025Thermal Decomposition of Device; Thermal Decomposition of Device

  A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED FINDING THERMAL DAMAGE ON A DRY ACID (132 GALLON UNIT) MIXER. THE BIOMED INITIALLY CONTACTED TECHNICAL SUPPORT (TS) DUE TO THE MIXER NOT FILLING. DURING FOLLOW-UP IT WAS REVEALED THAT A BURNING SMELL WAS ALSO NOTED. UPON FURTHER INVESTIGATION THE BIOMED NOTICED THE FILL VALVE WAS BURNT, AND SO WAS THE CONTROL BOARD. IN THE INITIAL REPORTING IT WAS DOCUMENTED THAT THE FILL VALVE "SMOKED". HOWEVER, DURING FOLLOW-UP THE BIOMED STATED THEY DID NOT SEE ANY SMOKE, SPARKS, OR FLAMES. THEY WERE ABLE TO FIX THE MACHINE BY REPLACING THE FILL VALVE AND THE CONTROL BOARD. THE REPORTED ISSUE DID NOT IMPACT ANY PATIENT TREATMENTS. THE BIOMED SAID THE MACHINE WAS REPAIRED THE SAME DAY THE FILLING ISSUES STARTED, AND THE REPAIR ONLY TOOK APPROXIMATELY ONE HOUR. THERE WERE NO PHOTOS OF THE THERMAL DAMAGE TO PROVIDE, AND THE BIOMED SAID THE DAMAGED PARTS WERE DISCARDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21174857 ↗
• MalfunctionOct 25, 2024Thermal Decomposition of Device; Thermal Decomposition of Device

  A USER FACILITY'S BIOMEDICAL TECHNICIAN (BMT) REPORTED THAT A DRY ACID MIXER WAS NOT FILLING. DURING REPAIR, THE BMT NOTICED THAT THE CONNECTION BETWEEN THE FILL VALVE AND THE FILL VALVE CABLE WAS BURNT. IT IS UNKNOWN IF THE MIXER HAS BEEN RETURNED TO SERVICE. IT IS UNKNOWN IF THE COMPLAINT DEVICE IS AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. NO PATIENT WAS INVOLVED. MULTIPLE ATTEMPTS HAVE BEEN MADE TO CONTACT THE BMT TO OBTAIN ADDITIONAL INFORMATION RELATED TO THE REPORTED EVENT. AT THIS TIME, NO ADDITIONAL INFORMATION HAS BEEN PROVIDED. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE FILE WILL BE UPDATED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20533491 ↗
• MalfunctionOct 18, 2024Thermal Decomposition of Device; Thermal Decomposition of Device

  A USER FACILITY'S BIOMEDICAL TECHNICIAN (BMT) REPORTED THAT A DRY ACID MIXER WAS NOT FILLING DURING DISSOLUTION OR RINSE MODES. DURING REPAIR, THE BMT NOTED THAT THE FILL VALVE WAS BURNED AND SCORCHED. NO PATIENT WAS INVOLVED. IT IS UNKNOWN IF THE COMPLAINT DEVICE IS AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. 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. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE FILE WILL BE UPDATED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20482277 ↗
• MalfunctionOct 14, 2024Thermal Decomposition of Device; Thermal Decomposition of Device

  A USER FACILITY'S BIOMEDICAL TECHNICIAN (BMT) REPORTED THAT A FRESENIUS DRY ACID MIXER WAS NOT FILLING. A FRESENIUS FIELD SERVICE TECHNICIAN (FST) WAS CALLED ONSITE AND FOUND THAT THE FILL VALVE WAS BURNED OUT AND THE UNION FITTING CONNECT TO THE VALVE WAS SPLIT IN HALF. THE FST PROVIDED PART NUMBERS TO THE CUSTOMER SO THEY COULD ORDER NEW ONES. 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. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE FILE WILL BE UPDATED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20440244 ↗
• MalfunctionOct 11, 2024Thermal Decomposition of Device; Thermal Decomposition of Device

  A USER FACILITY¿S BIOMEDICAL TECHNICIAN (BMT) REPORTED THAT A FRESENIUS DRY ACID MIXER WOULD NOT FILL TO THE FINAL FILL LEVEL. WHILE FILLING, THERE WAS SMOKE AND A BURNING SMELL. 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. IT IS UNKNOWN IF THE COMPLAINT DEVICE IS AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. 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. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE FILE WILL BE UPDATED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20427569 ↗
• MalfunctionSep 11, 2024Thermal Decomposition of Device; Fire; Smoking; Thermal Decomposition of Device; Fire; Smoking

  A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO FRESENIUS TECHNICAL SUPPORT (TS) THAT A 132 GALLON UNIT DRY ACID MIXER HAD AN INLET FILL VALVE THAT FAILED. THE BIOMED REPORTED THAT THE COMPONENT LIT ON FIRE. THE BIOMED WAS ASKING FOR THE PART NUMBER FOR A NEW VALVE. ADDITIONAL DETAILS WERE PROVIDED UPON FOLLOW-UP WITH THE BIOMED. THE BIOMED STATED THERE WERE NO OTHER KNOWN ISSUES WITH THE MIXER. THE BIOMED HAD PRESSED THE RINSE/FILL START BUTTON, AND THE INLET FILL VALVE MADE AN UNUSUAL NOISE. A BURNING SMELL WAS REPORTEDLY NOTICED. THE BIOMED THEN NOTICED A HUMMING NOISE, FOLLOWED BY SMOKE AND FIRE. THE BIOMED CONFIRMED THEY SAW A VISIBLE FLAME WITHIN THE CABINET, WHERE THE FILL VALVE IS LOCATED. THE VALVE DID NOT MELT; HOWEVER, THE VALVE CABLE AND CONTROL MODULE WERE AFFECTED. A SUSPECTED CAUSE OF THE FAILURE WAS UNKNOWN. THE REPORTED PROBLEM DID NOT RESULT IN ANY MISSED TREATMENTS. THE BIOMED WAS ABLE TO FIX THE MIXER BY REPLACING THE INLET FILL VALVE, THE VALVE CABLE, AND THE CONTROL MODULE. THE MACHINE WAS BACK IN SERVICE AND FULLY OPERATIONAL. A PHOTO OF THE FILL VALVE WAS PROVIDED, IN WHICH EVIDENCE OF SMOKE RESIDUE CAN BE SEEN ON THE WALL OF THE MIXER TANK. THE V

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20197152 ↗
• MalfunctionAug 23, 2024Thermal Decomposition of Device; Thermal Decomposition of Device

  A USER FACILITY¿S BIOMEDICAL TECHNICIAN (BMT) REPORTED THAT A FRESENIUS DRY ACID MIXER HAD A CRACKED, BURNT AND MELTED FILL VALVE THAT EMITTED A BURNING SMELL. THERE WAS NO REPORT OF SMOKE, SPARKS, FLAMES OR ARCING. THE ISSUE WAS NOTICED DURING MIXING. 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 FILL VALVE 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 REPORTED ISSUE. THE BIOMED IS STILL WAITING FOR A REPLACEMENT PART TO ARRIVE, SO THE MIXER IS OUT OF SERVICE. THE FILL VALVE IS AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 20049547 ↗
• MalfunctionAug 7, 2024Smoking; Smoking

  A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO FRESENIUS TECHNICAL SERVICES THAT THE FILL VALVE OF THE DRY ACID MIXER SMOKED UPON INITIATING FILL. THERE WERE 0 VOLTS OF POWER GOING TO THE VALVE. THE BIOMED WAS ADVISED TO REPLACE THE FILL VALVE AND CONTROL BOARD (AND RELATED SOFTWARE). ADDITIONAL INFORMATION WAS OBTAINED DURING FOLLOW-UP. THE BIOMED STATED THAT A LARGE AMOUNT OF WHITE SMOKE CAME FROM THE FILL VALVE OF THE MIXER DURING DISSOLUTION MODE. THE BIOMED NOTED THAT THE MIXER HAD ALSO BEEN FILLING SLOWLY THE PAST FEW TIMES IT HAD BEEN USED. THERE WAS NO OBSERVED SPARK, FLAME, OR ARCING. THE FACILITY SMOKE DETECTORS WERE NOT TRIGGERED BY THE SMOKE FROM THE MIXER. A FIRE EXTINGUISHER WAS NOT REQUIRED TO ADDRESS THE ISSUE. THE BIOMED STATED THE SMOKE DISSIPATED AFTER THE MACHINE WAS POWERED OFF AND UNPLUGGED. THERE WAS NO HARM TO ANY PATIENTS OR INDIVIDUALS AS A RESULT OF THE REPORTED EVENT. THE BIOMED STATED UPON EXAMINATION THAT THE FILL VALVE DID NOT APPEAR TO BE BURNED, HOWEVER THERE WAS A SLIGHT CRACK DOWN THE SIDE OF IT AND IT APPEARED WET AS IF FROM OIL BUT COULD NOT BE CLEANED. UPON TESTING IT WAS ALSO CONFIRMED THAT THE CONTROL BOARD WAS DAMAGED BY THE FILL

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19933548 ↗
• MalfunctionJun 11, 2024Thermal Decomposition of Device; Thermal Decomposition of Device

  A USER FACILITY¿S BIOMEDICAL TECHNICIAN (BMT) REPORTED THAT A FRESENIUS DRY ACID MIXER HAD THERMAL DAMAGE TO THE WATER INLET VALVE AND IT¿S CABLE HAD MOISTURE IN IT. A FRESENIUS FIELD SERVICE TECHNICIAN (FST) WAS CALLED ONSITE AND REPLACED THE WATER INLET VALVE AND CABLE. THE MIXER WAS STILL NOT FILLING, SO THEY REPLACED THE CONTROL VALVE AND THE 25 GALLON SENSOR TO RESOLVE THE ISSUE. THE DRY ACID MIXER HAS BEEN RETURNED TO SERVICE. 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. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE FILE WILL BE UPDATED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19509703 ↗
• MalfunctionMay 15, 2024Thermal Decomposition of Device; Thermal Decomposition of Device

  AN AREA TECHNICAL OPERATIONS MANAGER (ATOM) CONTACTED FRESENIUS TECHNICAL SUPPORT (TS) TO REPORT A DRY ACID MIXER (132-GALLON UNIT) THAT HAD A DEFECTIVE FILL VALVE AND CONTROL BOARD. UPON INSPECTION OF THE UNIT, THE ATOM REPORTED THAT THE FILL VALVE APPEARED BURNT. ADDITIONAL DETAILS WERE PROVIDED UPON FOLLOW-UP WITH THE ATOM AND THE BIOMEDICAL TECHNICIAN (BIOMED) FROM THE FACILITY WHERE THE EVENT OCCURRED. DURING THE FILL CYCLE, IT WAS REPORTED THAT A BURNING SMELL WAS COMING FROM THE MIXER, AND THE MIXER WASN¿T FILLING. IT WAS ALSO REPORTED THAT SMOKE WAS COMING FROM THE UNIT. THE BIOMED HAD TO OPEN THE DOORS TO AIR OUT THE SMELL INSIDE THE MIXER ROOM. THE SMOKE DID NOT TRIGGER THE SMOKE ALARM TO GO OFF. THERE WERE NO SIGNS OF ANY SPARKS, ARCING, OR FLAMES. THE FACILITY RECEIVED A NEW FILL VALVE, BUT THEY ARE STILL WAITING ON A CONTROL PANEL. THE DEFECTIVE FILL VALVE, WHICH WAS CONFIRMED TO HAVE EVIDENCE OF THERMAL DAMAGE ON IT, WAS SENT BACK FOR EVALUATION. THE ATOM WAS TOLD THAT FRESENIUS NOW USES A DIFFERENT SUPPLIER FOR THE FILL VALVES THAN THEY USED TO. THE NEW FILL VALVES PULL TOO MUCH CURRENT AND TEND TO RUN HOT, WHICH CAN BLOW OUT THE CONTROL PANEL. THIS WAS WHAT HAPPENED

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19326229 ↗
• MalfunctionApr 25, 2024Thermal Decomposition of Device; Thermal Decomposition of Device

  A BIOMEDICAL TECHNICIAN (BIOMED) AT A USER FACILITY REPORTED THAT A FRESENIUS DRY ACID MIXER WAS NOT FILLING AND HAD A BURNING SMELL COMING FROM THE FILL VALVE. THE FILL VALVE HAD CHARRING ON THE BODY OF THE VALVE AND A LITTLE SMOKE WAS OBSERVED. THE FACILITY¿S SMOKE DETECTORS DID NOT GO OFF AS A RESULT. THE CHARRED VALVE WAS NOTICED DURING MACHINE REPAIR. 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 MACHINE HOURS ARE UNKNOWN. THE FILL VALVE WAS THE ORIGINAL FRESENIUS PART ON THE MACHINE. THE MIXER IS PLUGGED IN TO A HOSPITAL GRADE GROUND-FAULT CIRCUIT INTERRUPTER (GFCI) OUTLET. THE BMT REPORTED THAT THERE WAS NO DAMAGE OBSERVED ON ANY OTHER COMPONENTS, OR ANY OTHER ADDITIONAL ISSUES, ASSOCIATED WITH THE CHARRED FILL VALVE. THE BMT REPLACED THE CONTROL BOARD AND THE FILL VALVE TO RESOLVE THE REPORTED ISSUE. THE UNIT WAS RETURNED TO SERVICE AT THE USER FACILITY WITHOUT ISSUE AND WITHOUT REOCCURRENCE OF THE EVENT. THE FILL VALVE WAS RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19184672 ↗
• MalfunctionApr 22, 2024Thermal Decomposition of Device; Thermal Decomposition of Device

  A HEMODIALYSIS (HD) USER FACILITY REQUESTED ONSITE SERVICE FROM FRESENIUS TO REPAIR A 132-GALLON DRY ACID MIXER THAT WAS EXPERIENCING FILLING ISSUES. A FRESENIUS FIELD SERVICE TECHNICIAN (FST) WAS DISPATCHED TO THE USER FACILITY TO EVALUATE THE MACHINE. THE FST VERIFIED THE REPORTED FAILURE, INDICATING THAT WATER WAS NOT ENTERING THE TANK DURING FILL MODE. THE FST FOUND THAT THE INLET WATER VALVE WAS NOT OPENING AND NEEDED TO BE REPLACED. THE FST REPLACED THE INLET WATER VALVE TO RESOLVE THE REPORTED ISSUE. AS A PRECAUTION, THE FST ALSO REPLACED THE CONTROL CONSOLE. UPON COMPLETION OF THE REPAIR, THE FST VERIFIED THE MIXER WAS WORKING CORRECTLY AND WAS FILLING DURING THE FILL STEP. A FILL VALVE WAS RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION. UPON EVALUATION OF THE RETURNED PART, THERMAL DAMAGE WAS IDENTIFIED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19160760 ↗
• MalfunctionApr 15, 2024Thermal Decomposition of Device; Thermal Decomposition of Device

  A USER FACILITY¿S BIOMEDICAL TECHNICIAN (BMT) REPORTED THAT DURING DISSOLUTION MODE, A DRY ACID MIXER WAS NOT FILLING, AND THEY FOUND A CHARRED FILL VALVE AND SMELLED A BURNING SMELL. UPON FOLLOW UP, THE BMT SAID THAT THERE WAS DAMAGE TO THE FILL VALVE, ELECTRIC WIRE HARNESS CONTROL PANEL TO THE FILL VALVE AND THE CONTROL PANEL. THE FILL VALVE WAS FRIED AND CHARRED. THERE WAS ALSO WATER INSIDE THE ELECTRICAL HARNESS OF THE FILL SOLENOID. THE CONTROL PANEL HAD A CHARRED SMELL. THERE WAS SMOKE AND A STRONG ELECTRICAL BURNING SMELL. ARCING WAS NOT WITNESSED, BUT THE CHARRING ON THE SOLENOID VALVE INDICATED THAT ARCING OCCURRED. THE FIRE ALARM DID NOT SOUND, BUT THE ROOM NEEDED TO BE VENTED BY OPENING THE DOORS. THE MACHINE HOURS ARE NOT APPLICABLE AS THIS IS A DRY ACID MIXER. THE COMPONENTS WERE ALL ORIGINAL TO THE FRESENIUS MACHINE. THE MACHINE IS PLUGGED INTO A HOSPITAL GRADE GROUND-FAULT CIRCUIT INTERRUPTER (GFCI) OUTLET. THE BMT REPLACED THE FILL VALVE AND ELECTRICAL HARNESS, BUT THE MIXER WOULD NOT FILL. THEY THEN REPLACED THE CONTROL PANEL BOARD TO RESOLVE THE ISSUE. THE MIXER HAS BEEN RETURNED TO SERVICE. NO PHOTOS ARE AVAILABLE. A SAMPLE WAS REPORTED TO BE AVAILABLE TO BE RETU

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 19105086 ↗
• MalfunctionMar 28, 2024Thermal Decomposition of Device; Thermal Decomposition of Device

  A USER FACILITY¿S BIOMEDICAL TECHNICIAN (BMT) REPORTED TO TECHNICAL SUPPORT THAT DRY ACID MIXER HAD A BURNED CONTROL BOARD. UPON POWER UP, THERE WAS A BURNING SMELL AND IT WAS FOUND THAT THE CONTROL BOARD WAS BURNT. THERE WAS NO HARM TO ANY PATIENTS OR INDIVIDUALS BECAUSE OF THIS MALFUNCTION. THE COMPLAINT DEVICE IS NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR EVALUATION. 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. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE FILE WILL BE UPDATED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18992341 ↗
• MalfunctionFeb 26, 2024Smoking; Smoking

  A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO FRESENIUS THAT SMOKE WAS SMELLED AND VISUALLY OBSERVED COMING FROM A DRY ACID MIXER. THE REPORTED ISSUE WAS CONFIRMED DURING FOLLOW-UP WITH THE BIOMED AND ADDITIONAL INFORMATION WAS OBTAINED. THE BIOMED WAS CONTACTED BY THE FACILITY WHEN THE DRY ACID MIXER WOULD NOT START. PLUGGING THE DRY ACID MIXER INTO A DIFFERENT OUTLET DID NOT RESOLVE THE REPORTED ISSUE. THE BIOMED CAME ONSITE TO EVALUATE THE MIXER. THE BIOMED STATED THE FILL VALVE WOULD NOT OPEN. SMOKE WAS SMELLED AND VISUALLY OBSERVED. THE MIXER WAS UNPLUGGED AND THE BACK DOOR WAS OPENED TO STOP THE SMOKE AND CLEAR IT. THE FACILITY SMOKE DETECTORS WERE NOT TRIGGERED. USE OF A FIRE EXTINGUISHER WAS NOT REQUIRED. THERE WAS NO HARM TO ANY PATIENTS OR INDIVIDUALS AS A RESULT OF THE REPORTED ISSUE. UPON REMOVING THE FILL VALVE FROM THE MACHINE THERE WERE NO VISUAL INDICATIONS OF THERMAL DAMAGE NOTED BUT IT WAS WARM TO THE TOUCH. THE FILL VALVE AND CONTROL PANEL WERE REPLACED TO RESOLVE THE REPORTED ISSUE. THE MIXER WAS RETURNED TO SERVICE. THE PARTS WERE DISCARDED AND ARE NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18778630 ↗
• MalfunctionFeb 23, 2024Thermal Decomposition of Device; Thermal Decomposition of Device

  A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) REPORTED TO FRESENIUS THAT A DRY ACID MIXER HAD THERMAL DECOMPOSITION ON THE FILL VALVE. 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. SHOULD ADDITIONAL INFORMATION BECOME AVAILABLE, THE FILE WILL BE UPDATED ACCORDINGLY.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18767997 ↗
• MalfunctionFeb 22, 2024Thermal Decomposition of Device; Melted; Thermal Decomposition of Device; Melted

  A FRESENIUS FIELD SERVICE TECHNICIAN (FST) WAS CALLED ONSITE BY A USER FACILITY BIOMEDICAL TECHNICIAN (BIOMED) TO EVALUATE A DRY ACID MIXER THAT EXPERIENCED A FLUID LEAK FROM THE POLYVINYL CHLORIDE (PVC) PIPES. THE FST FOUND WHEN THE WATER TANK FILLED DURING HEAT DISINFECTION THAT THE HIGH TEMPERATURE CAUSED THE PVC PIPING TO DISTORT AND MELT. REPLACEMENT PARTS WERE ORDERED. A SECOND FST CAME ONSITE UPON ARRIVAL OF THE PARTS TO COMPLETE THE REPAIR. THE MIXER PASSED FUNCTIONAL TESTING. ADDITIONAL INFORMATION WAS OBTAINED DURING FOLLOW-UP WITH THE USER FACILITY BIOMED AND FACILITY ADMINISTRATOR (FA). THE MIXER REMAINED OUT OF SERVICE UNTIL THE REPAIR WAS COMPLETED. JUGS WERE MANUALLY FILLED WHILE THE MACHINE REMAINED OUT OF USE. THERE WAS NO OBSERVED BURNING SMELL, SMOKE, SPARK, FLAME, OR ARCING. THERE WAS NO PERSONAL HARM TO ANY PATIENTS OR INDIVIDUALS AS A RESULT OF THE MALFUNCTION. IT WAS CONFIRMED THAT THE MACHINE IS PLUGGED INTO A HOSPITAL-GRADE GROUND-FAULT CIRCUIT INTERRUPTER (GFCI) OUTLET. THE PARTS WERE DISCARDED AND ARE NOT AVAILABLE TO BE RETURNED TO THE MANUFACTURER FOR PHYSICAL EVALUATION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18758774 ↗