Dry Acid Dissolution UnitRecalls & reported problems across all models

We found 2 models of Dry Acid Dissolution Unit by Fresenius Usa, Inc. in the FDA's device registry (GUDID). Together they are named in 150 adverse event reports in the FDA's MAUDE database, received between Jun 22, 2017 and Sep 4, 2026 — classified as 150 malfunctions.

The most frequently reported specific device problem is “Thermal Decomposition of Device” (102 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. Widely used products collect more reports, so totals can't be used to compare products or estimate failure rates. Only reports that name a model's exact device identifier are counted. What reports can and can't tell you · How this data works

Most reported Dry Acid Dissolution Unit problems

Dry Acid Dissolution Unit models

2 models, most reported first. Each model has its own page with its reports, recalls and device details.

• Dry Acid Dissolution Unit 160147

  DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)
  129 reports
• Dry Acid Dissolution Unit 160148

  DIALYSATE CONCENTRATE FOR HEMODIALYSIS (LIQUID OR POWDER)
  21 reports

Recent Dry Acid Dissolution Unit adverse event reports

The 15 most recent reports across all models, 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗
• 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 ↗

Other Fresenius Usa, Inc. products

• 2008 Series Hemodialysis Machines10 models · 1,768 reports · 15 recalls
• Crit-Line2 models · 77 reports