Dialog+Recalls & reported problems across all models

We found 4 models of Dialog+ by B.Braun Avitum AG in the FDA's device registry (GUDID). Together they are named in 63 adverse event reports in the FDA's MAUDE database, received between Mar 24, 2017 and Sep 2, 2026 — classified as 35 deaths, 20 injuries, 8 malfunctions.

The most frequently reported specific device problem is “Calibration Problem” (2 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 Dialog+ problems

Dialog+ models

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

• Dialog+® 710200L

  Dialyzer, high permeability with or without sealed dialysate system
  24 deaths42 reports
• Dialog+® 710200S

  Dialyzer, high permeability with or without sealed dialysate system
  11 deaths17 reports
• Dialog+® 710200K

  Dialyzer, high permeability with or without sealed dialysate system
  3 reports
• Dialog+® 710200U

  Dialyzer, high permeability with or without sealed dialysate system
  1 report

Recent Dialog+ adverse event reports

The 15 most recent reports across all models, in the reporter's own words as published by the FDA.

• DeathSep 2, 2026Adverse Event Without Identified Device or Use Problem

  Per customer description: Customer called requesting a B. Braun technical safety inspection of a machine involved in a patient incident. The caller reported that the incident occurred on (b)(6) 2026, and involved a patient fatality.A patient death was reported, the patient died after therapy. No sample device or machine data records were made available for investigation; therefore, the assessment was based on the available information and a service report.A technical safety inspection (TSI) was performed by a B. Braun technician on the reported machine, and no malfunction or product deviation was identified. The device was found to be functioning as intended. As a general risk mitigating principle all safety-relevant functions are checked before treatment and continuously monitored during therapy. Any detected malfunction would trigger the appropriate alarm. The technical safety inspection confirmed that the machine functioned as intended.It was reported by the customer that the patient presented to the Emergency Department after having missed multiple dialysis treatments. Furthermore, the patient had a documented history of repeated non-attendance and missed treatment sessions. Th

  Patient problems: Cardiac Arrest

  MAUDE report 50568067 ↗
• DeathJun 25, 2026Adverse Event Without Identified Device or Use Problem

  PER CUSTOMER DESCRIPTION: ON (B)(6) 2026, REPORTED ON 5/26/2026. PATIENT CODED APPROXIMATELY 3 HOURS INTO THERAPY. PATIENT WAS TRANSFERRED TO ICU AND PASSED THE FOLLOWING DAY. THE PATIENT CODED APPROXIMATELY THREE HOURS INTO TREATMENT. CPR WAS INITIATED, SALINE WAS ADMINISTERED, AND ALL BLOOD WAS SUCCESSFULLY RETURNED. IT WAS REPORTED THAT A PATIENT CODED DURING THERAPY, REQUIRING CARDIOPULMONARY RESUSCITATION (CPR) AND EMERGENCY INTERVENTION. CPR WAS INITIATED IMMEDIATELY, AND THE PATIENT WAS SUBSEQUENTLY TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU), WHERE THE PATIENT LATER PASSED AWAY. FOLLOWING THE EVENT, THE DEVICE WAS DISINFECTED AND SUBSEQUENTLY RETURNED TO OPERATION UNDER MONITORING. THE PROVIDED MACHINE DATA RECORDS COVER THE PERIOD FROM 20260524 TO 20260609, DURING WHICH THE DEVICE WAS IN USE AND NO ABNORMALITIES WERE REPORTED. NO MACHINE DATA FROM THE DATE OF THE EVENT (20260522) WAS AVAILABLE, AS THE SYSTEM STORES A MAXIMUM OF 20 RECORDS AND OLDER DATA IS AUTOMATICALLY OVERWRITTEN. THEREFORE, THE NEXT AVAILABLE TREATMENT RECORD FOLLOWING THE REPORTED EVENT WAS ANALYSED IN DETAIL. THE RECORD FROM 20260524 SHOWS A COMPLETE AND UNREMARKABLE CYCLE OF PREPARATION, THERAPY, EN

  Patient problems: Cardiac Arrest

  MAUDE report 25619549 ↗
• DeathMar 2, 2026Adverse Event Without Identified Device or Use Problem

  ACCORDING TO THE COMPLAINANT, ON (B)(6) 2026, AT APPROXIMATELY 11:30 AM, A PATIENT EXPERIENCED A CARDIAC ARREST WHILE UNDERGOING HEMODIALYSIS TREATMENT. THE CUSTOMER REPORTED THAT THE PATIENT "CODED" DURING DIALYSIS THERAPY. THE EVENT OCCURRED DURING ACTIVE TREATMENT ON THE DIALYSIS MACHINE. THE PATIENT WAS RESUSCITATED AND TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU). SUBSEQUENT FOLLOW-UP WITH THE ACCOUNT REVEALED THAT ON (B)(6) 2026, THE FAMILY WITHDREW CARE AND THE PATIENT DIED. IT WAS REPORTED THAT DURING THERAPY THE PATIENT HAD A CARDIAC ARREST. THE PATIENT WAS RESUSCITATED AND TRANSFERRED TO THE ICU. THE NEXT DAY THE PATIENT'S FAMILY WITHDREW CARE AND THE PATIENT DIED. ANALYSIS: THE SERVICE REPORT RECEIVED SHOWS THAT THE MACHINE WAS CHECKED BY A B. BRAUN TECHNICIAN, AND NO FAILURE WAS FOUND. THE MACHINE WORKED AS INTENDED. THE INVESTIGATION OF THE RECEIVED MACHINE DATA RECORD SHOWS THAT DURING PREPARATION ALL SELF-TESTS WERE PASSED, AND THERAPY WAS STARTED. WITHIN THE FIRST 2 HOURS THE THERAPY RAN SMOOTHLY WITHOUT ANY CONSPICUOUS ALARMS. AT APPROXIMATELY 2:08 HOURS AFTER PATIENT CONNECTION, THE MACHINE BEGAN TRIGGERING A SERIES OF BLOOD-SIDE PRESSURE ALARMS. OVER THE NEXT 10

  Patient problems: Cardiac Arrest

  MAUDE report 24485182 ↗
• DeathJan 27, 2026Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE USER FACILITY: PATIENT CODED, ALL OTHER INFORMATION IS UNKNOWN AT THIS TIME. A PATIENT DEATH WAS REPORTED WHILE USING THE MACHINE. DESPITE SEVERAL ATTEMPTS, NO SAMPLE, NO MACHINE DATA RECORD OF THE AFFECTED THERAPY, OR ADDITIONAL INFORMATION WAS MADE AVAILABLE. A TECHNICAL SAFETY INSPECTION (TSI) OF THE MACHINE WAS PERFORMED AND PASSED SUCCESSFULLY, CONFIRMING THAT THE MACHINE WORKED AS INTENDED, WITH NO FAILURES DETECTED AND NO PRODUCT DEVIATION IDENTIFIED. ALL SAFETY-RELEVANT FUNCTIONS ARE VERIFIED DURING MANDATORY SELF-TESTS OF THE MACHINE IN ITS PREPARATION PHASE. THERAPY CANNOT START UNLESS THESE SELF-TESTS ARE SUCCESSFULLY COMPLETED. DURING THERAPY, ALL SAFETY-RELEVANT COMPONENTS AND FUNCTIONS ARE CONTINUOUSLY MONITORED. IF A SAFETY-RELEVANT MALFUNCTION OCCURS, THE MACHINE TRIGGERS AN ALARM AND SWITCHES TO PATIENT-SAFE MODE. CONCLUSION: BASED ON THE ANALYSIS AND EVALUATION OF THE REPORTED INFORMATION AND THE OUTCOME OF THE TECHNICAL SAFETY INSPECTION, THERE WAS NO MALFUNCTION OF THE DEVICE, AND THE DEVICE DID NOT CONTRIBUTE TO THE PATIENT'S DEATH. THIS CASE IS CLASSIFIED AS NOT REPORTABLE TO THE COMPETENT AUTHORITY BY THE MANUFACTURER.

  Patient problems: Electric Shock

  MAUDE report 24187824 ↗
• DeathOct 22, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE USER FACILITY:ACCORDING TO THE COMPLAINANT, THE PATIENT CODED AND PASSED AWAY WHILE UNDERGOING DIALYSIS TREATMENT. THE TREATMENT DURATION WAS REPORTED TO BE LESS THAN TWO HOURS. ALTHOUGH REQUESTED, NO ADDITIONAL INFORMATION HAS BEEN MADE AVAILABLE. IT WAS REPORTED THAT A PATIENT CODED AND PASSED AWAY WHILE UNDERGOING DIALYSIS TREATMENT. THE TREATMENT DURATION WAS REPORTED TO BE LESS THAN TWO HOURS. UNFORTUNATELY, NO ADDITIONAL INFORMATION WAS PROVIDED. DESPITE MULTIPLE FOLLOW-UP ATTEMPTS, NO DETAILS REGARDING A TECHNICAL INSPECTION OR THE MACHINE'S CONDITION WERE SHARED. FURTHERMORE, NO MACHINE DATA RECORDS WERE MADE AVAILABLE TO SUPPORT THE INVESTIGATION. AS A RESULT, THE ASSESSMENT WAS CONDUCTED BASED SOLELY ON THE INFORMATION AND DATA AT HAND. ALL SAFETY RELEVANT FUNCTIONS ARE TESTED DURING THE MACHINE'S SELF-TESTS IN PREPARATION. IF THERE IS A SAFETY RELEVANT ERROR, NO THERAPY START IS POSSIBLE. IF A SAFETY RELEVANT MALFUNCTION OCCURS IN THERAPY, THE MACHINE TRIGGERS AN ALARM AND SWITCHES TO PATIENT-SAFE MODE. BASED ON THE AVAILABLE INFORMATION, THE CAUSE FOR THE PATIENT DEATH IS NOT COMPREHENSIBLE. NO MACHINE FAILURE WAS REPORTED. BASED ON THE PRECEDING INFO

  Patient problems: Cardiac Arrest

  MAUDE report 23359067 ↗
• DeathAug 20, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE USER FACILITY: AN 84-YEAR-OLD MALE PATIENT WITH A SIGNIFICANT MEDICAL HISTORY WAS UNDERGOING HEMODIALYSIS THERAPY USING AN OPTIFLUX F180NR DIALYZER. DURING THE SESSION, APPROXIMATELY 2.44 HOURS INTO THERAPY, THE PATIENT BECAME UNRESPONSIVE. THE DIALYSIS NURSE NOTED HYPOTENSION DURING TREATMENT AND SUBSEQUENTLY OBSERVED THE PATIENT TO BE UNRESPONSIVE, WITH BLOOD PRESSURE AND PULSE OXIMETRY READINGS UNOBTAINABLE. BLOOD WAS RETURNED TO THE PATIENT, AND THE ATTENDING PHYSICIAN ASSESSED THE PATIENT. GIVEN THE PATIENT'S DO NOT RESUSCITATE (DNR) STATUS, NO MEDICAL INTERVENTION WAS PERFORMED. THE PATIENT WAS PRONOUNCED DECEASED AT (B)(6) 2025. NOTE FROM THE MANUFACTURER: A TECHNICAL SAFETY INSPECTION OF THE MACHINE WAS PERFORMED. THE TSI WAS PASSED, CONFIRMING THAT THE MACHINE WORKS AS INTENDED. THE INVESTIGATION OF THE RECEIVED MACHINE DATA RECORD FROM (B)(6) 2025, 8:18 O´CLOCK SHOWS THAT DURING PREPARATION ALL SELF-TESTS WERE PASSED, AND THERAPY WAS STARTED. APPROX. 21 MINUTES AFTER THERAPY START THE MACHINE STARTED TO TRIGGER THE ALARM "TMP OUT OF ALARM LIMITS" BECAUSE THE TRANSMEMBRANE PRESSURE TMP EXCEEDED THE LIMIT. THIS ALARM HAS NO FURTHER MACHINE REACTION AND IS

  Patient problems: Cardiac Arrest

  MAUDE report 22850971 ↗
• MalfunctionMar 19, 2025Calibration Problem; Calibration Problem

  EVENT 4: ACCORDING TO THE EVENT DESCRIPTION: DURING THE INSTALLATION PROCESS OF 42 DIALOG+ HDF ONLINE (EVO) EQUIPMENT (CODE: 7102072) AND DIALOG+ C/ SUP. CARD. BIC (EVO) (CODE: 710200C) IN THE (B)(6), A SIGNIFICANT DEVIATION WAS IDENTIFIED IN THE CALIBRATION PROCESS OF THE MEASURING INSTRUMENTS. WHEN CARRYING OUT THE TESTS, IT WAS OBSERVED THAT FOR A NOMINAL VALUE OF 14.30 MS/CM CONFIGURED IN DIALOG, THE MEASURING INSTRUMENT (B)(6) (MANUFACTURER: IBP, MODEL: HDM97BQ) PRESENTED READINGS CLOSE TO 16.00 MS/CM, SIGNIFICANTLY ABOVE THE ESTABLISHED TOLERANCE OF ±0.1 MS/CM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21643810 ↗
• MalfunctionMar 19, 2025Calibration Problem; Calibration Problem

  EVENT 7: ACCORDING TO THE EVENT DESCRIPTION: DURING THE INSTALLATION PROCESS OF 42 DIALOG+ HDF ONLINE (EVO) EQUIPMENT (CODE: 7102072) AND DIALOG+ C/ SUP. CARD. BIC (EVO)(CODE:710200C) IN THE (B)(6) HOSPITAL, A SIGNIFICANT DEVIATION WAS IDENTIFIED IN THE CALIBRATION PROCESS OF THE MEASURING INSTRUMENTS. WHEN CARRYING OUT THE TESTS, IT WAS OBSERVED THAT FOR A NOMINAL VALUE OF 14.30 MS/CM CONFIGURED IN DIALOG, THE MEASURING INSTRUMENT EAN0473 (MANUFACTURER: IBP, MODEL: HDM97BQ) PRESENTED READINGS CLOSE TO 16.00 MS/CM, SIGNIFICANTLY ABOVE THE ESTABLISHED TOLERANCE OF ±0.1 MS/CM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 21643807 ↗
• DeathDec 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE USER FACILITY: ON 11/12/2024, B BRAUN US DEVICE MANUFACTURING, LLC, WAS NOTIFIED OF AN INCIDENT OCCURRING ON (B)(6) 2024 INVOLVING DIALOG MACHINE SERIAL NUMBER (B)(6). THE INCIDENT WAS A PATIENT PASSED AWAY WHILE RECEIVING TREATMENT ON THE MACHINE. THE CUSTOMER REPORTED THAT THE PATIENT'S BLOOD PRESSURE DROPPED; IV FLUIDS WERE GIVEN BUT NO ATTEMPTS WERE MADE TO RESUSCITATE BECAUSE THE PATIENT HAD A DNR DIRECTIVE. AT THIS TIME, THE CUSTOMER STATED THAT THEY DO NOT THINK THE MACHINE WAS RELATED TO THE INCIDENT. THE MACHINE IS SCHEDULED TO UNDERGO A TECHNICAL SAFETY INSPECTION, AT CUSTOMER'S REQUEST. THE MACHINE'S HOURS OF OPERATION ARE UNKNOWN AT THIS TIME BUT WILL BE PROVIDED IN THE TSI REPORT. THE WORK ORDER IS (B)(4). ADDITIONAL MANUFACTURER NARRATIVE: IT WAS REPORTED THAT DURING A THERAPY WITH THE DIALOG DIALYSIS MACHINE REPORTED IN THIS CASE, THE PATIENT PASSED AWAY. CAUSE OF DEATH WAS A CARDIAC ARREST. THE CUSTOMER STATED THAT NO RELATION TO THE DEVICE IS ESTABLISHED. THE SERVICE REPORT RECEIVED FROM THE TECHNICAL SAFETY INSPECTION (TSI) SHOWS NO FAILURE OF THE MACHINE. ALL TESTS WERE PASSED. THE INVESTIGATION OF THE RECEIVED MACHINE DATA RECORD OF THE CONCER

  Patient problems: Cardiac Arrest

  MAUDE report 20907070 ↗
• DeathAug 22, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  THE CUSTOMER REPORTED THAT ON (B)(6) 2024, A PATIENT WAS HOOKED UP TO THE DIALOG MACHINE FOR DIALYSIS TREATMENT AND 15 MINUTES INTO TREATMENT, THE PATIENT'S VENOUS BLOODLINE DETACHED FROM HIS CENTRAL VENOUS CATHETER (CVC). THE PATIENT EXSANGUINATED AND CODED. THE PATIENT WAS BRIEFLY RESUSCITATED AND TRANSPORTED TO THE HOSPITAL, WHICH WAS ABOUT ¼ MILE AWAY FROM THE DIALYSIS CENTER, WHERE HE CODED A SECOND TIME AND EXPIRED. THE PATIENT WAS A 70-YEAR-OLD MALE. HE WAS NOT NEW TO DIALYSIS, BUT HE WAS ALSO NOT A LONG-TERM PATIENT. HIS ACCESS WAS A CVC. THE FOLLOWING QUESTIONS WERE ANSWERED BY THE CUSTOMER VIA EMAIL AS FOLLOW-UP INFORMATION: HOW WAS THE INCIDENT DISCOVERED? DISCOVERED BY PCT WORKING WITH PATIENT. WHAT HOSPITAL WAS THE PATIENT TRANSPORTED TO? (B)(6). WHAT MEDICAL INTERVENTIONS WERE NEEDED AT THE DIALYSIS CENTER AND WHAT WAS NEEDED LATER AT THE HOSPITAL? CPR, CLAMPING BLOOD LINES / INTUBATION AND BLOOD ADMINISTRATION. DID THE MACHINE ALARM AT THE TIME OF THE EVENT? YES - LOGS SHOWED A VENOUS ALARM WAS SILENCED AND A MANUAL BLOOD PRESSURE WAS STARTED. CAN ADDITIONAL INFORMATION BE PROVIDED ON THE BLOODLINE DETACHMENT. SPECIFICALLY, WHERE ON THE BLOODLINE DID THE DETACHMENT O

  Patient problems: Cardiac Arrest; Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20044598 ↗
• MalfunctionMar 27, 2023Material Disintegration; Particulates

  MANUFACTURE: B BRAUN DIALOG PLUS DIALYSIS MACHINE. THE FPE FLOW PUMP GEAR HEAD HAD A MAGNET IN THE DRIVE ASSEMBLY THAT DISINTEGRATED LEAVING BLACK PARTICULATE MATTER IN THE INTERNAL HYDRAULIC TUBING AND FILTERS. THE DISINTEGRATED FERRITE CAN LEAD TO FUTURE PROBLEMS WITH REGULATORS, SOLENOID VALVES AND PUMPS. THE MACHINE SERIAL NUMBER IS (B)(4). THE MANUFACTURES GEAR PUMP PART NUMBER IS 34561927. A PRODUCT COMPLAINT WAS FILED WITH THE MANUFACTURE B BRAUN ON 3/23/23.

  Patient problems: Insufficient Information

  MAUDE report 16627701 ↗
• DeathFeb 20, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE USER FACILITY: CUSTOMER STATES THAT HE WAS TOLD BY HIS FACILITY'S SAFETY OFFICER THAT THE DIALYSIS NURSE LEFT THE PATIENT ROOM TO USE THE RESTROOM, AND THAT WHEN SHE RETURNED THE PATIENT'S VENTILATOR WAS ALARMING SO SHE CALLED FOR HELP FROM THE ICU STAFF. PATIENT HAD BEEN MADE A DNR EARLIER IN THE DAY SO NO ACLS WAS PERFORMED AT THIS TIME, AND PATIENT EXPIRED. PATIENT WAS THEN REMOVED FROM THE DIALYSIS MACHINE.

  Patient problems: Insufficient Information

  MAUDE report 16406010 ↗
• DeathFeb 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE USER FACILITY: CUSTOMER STATES THAT HE WAS TOLD BY HIS FACILITY'S SAFETY OFFICER THAT THE DIALYSIS NURSE LEFT THE PATIENT ROOM TO USE THE RESTROOM, AND THAT WHEN SHE RETURNED THE PATIENT'S VENTILATOR WAS ALARMING SO SHE CALLED FOR HELP FROM THE ICU STAFF. PATIENT HAD BEEN MADE A DNR EARLIER.

  Patient problems: Cardiac Arrest

  MAUDE report 16382623 ↗
• InjuryFeb 14, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE USER FACILITY: CUSTOMER REPORTED PATIENT CODED ON THE MACHINE AND WAS QUESTIONING THE RESULTS OF THE ELECTROLYTE COMPOSITION OF THE DIALYSATE THAT WAS TESTED.

  Patient problems: Cardiac Arrest

  MAUDE report 16372847 ↗
• InjuryFeb 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE USER FACILITY: CUSTOMER REPORTED PATIENT CODED ON THE MACHINE AND WAS QUESTIONING THE RESULTS OF THE ELECTROLYTE COMPOSITION OF THE DIALYSATE THAT WAS TESTED.

  Patient problems: Cardiac Arrest

  MAUDE report 16364616 ↗