Dialog+® 710200LRecalls & reported problems

Summary

The FDA's MAUDE database contains 42 adverse event reports that list this exact device (DI 04046963686345), received between Mar 24, 2017 and Sep 2, 2026 — classified as 24 deaths, 13 injuries, 5 malfunctions.

The most frequently reported specific device problem is “Retraction Problem” (2 reports).

8 other recalls cover devices cleared under the same FDA submission (K083460, K963440); they may or may not involve this specific model.

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 25 most recent of 42 reports, 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 ↗
• 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 ↗
• 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 ↗
• 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 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE USER FACILITY: CUSTOMER REPORTED THAT THEY HAD A PATIENT ISSUE WITH HEMOLYSIS LOOKING AT THE MACHINE DATA FOR THE TREATMENT IT INDICATED LOW PRESSURE DURING THERAPY HOWEVER THE STAFF INDICATED HIGH PRESSURE. THE CUSTOMER HAS COMPLETELY VERIFIED FUNCTIONALITY OF THE MACHINE. BLOOD HANDLING PRESSURE SENSORS ALONG WITH CONDUCTIVITY AND BLOOD PUMP ROLLER. UNFORTUNATELY THE STAFF FAILED TO SAVE THE DIALYZER AND BLOOD TUBING. PATIENT OUTCOME WAS GOOD BUT HOSPITALIZATION WAS NECESSARY FOR SEVERAL DAYS DUE TO THE HIGH VOLUME OF DAMAGED RED BLOOD CELLS.

  Patient problems: Hemolysis

  MAUDE report 16340195 ↗
• InjuryFeb 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE USER FACILITY: CUSTOMER REPORTED THAT THEY HAD A PATIENT ISSUE WITH HEMOLYSIS LOOKING AT THE MACHINE DATA FOR THE TREATMENT IT INDICATED LOW PRESSURE DURING THERAPY HOWEVER THE STAFF INDICATED HIGH PRESSURE. THE CUSTOMER HAS COMPLETELY VERIFIED FUNCTIONALITY OF THE MACHINE. BLOOD HANDLING PRESSURE SENSORS ALONG WITH CONDUCTIVITY AND BLOOD PUMP ROLLER. UNFORTUNATELY THE STAFF FAILED TO SAVE THE DIALYZER AND BLOOD TUBING. PATIENT OUTCOME WAS GOOD BUT HOSPITALIZATION WAS NECESSARY FOR SEVERAL DAYS DUE TO THE HIGH VOLUME OF DAMAGED RED BLOOD CELLS.

  Patient problems: Hemolysis

  MAUDE report 16340062 ↗
• DeathJan 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE USER FACILITY: PATIENT CODED AND PASSED WHILE BEING TREATED.

  Patient problems: Cardiac Arrest

  MAUDE report 16188307 ↗
• DeathJan 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE USER FACILITY: PATIENT CODED AND PASSED WHILE BEING TREATED.

  Patient problems: Cardiac Arrest

  MAUDE report 16188287 ↗
• DeathJan 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE USER FACILITY: PATIENT HAD CHILLS BEFORE DIALYSIS WAS PERFORMED. PATIENT WAS DIALYZED WITHOUT ALARMS AND CODED. PATIENT WAS REVISED ON TAKEN OFF THE MACHINE. PATIENT WAS SENT TO ICU AND PASSED AWAY.

  Patient problems: Cardiac Arrest

  MAUDE report 16160700 ↗
• DeathJan 13, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE USER FACILITY: PATIENT HAD CHILLS BEFORE DIALYSIS WAS PERFORMED. PATIENT WAS DIALYZED WITHOUT ALARMS AND CODED. PATIENT WAS REVISED ON TAKEN OFF THE MACHINE. PATIENT WAS SENT TO ICU AND PASSED AWAY.

  Patient problems: Cardiac Arrest

  MAUDE report 16156934 ↗
• DeathJan 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE USER FACILITY: PATIENT PASSED AWAY 2 HRS AFTER TREATMENT. PATIENT WAS REMOVED FROM THERAPY WITH 20 MINUTES LEFT.

  Patient problems: Cardiac Arrest

  MAUDE report 16089578 ↗
• DeathJan 3, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE USER FACILITY: PATIENT PASSED AWAY 2 HRS AFTER TREATMENT. PATIENT WAS REMOVED FROM THERAPY WITH 20 MINUTES LEFT.

  Patient problems: Cardiac Arrest

  MAUDE report 16089516 ↗
• InjuryOct 25, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT A VENOUS NEEDLE DISLODGED WITHOUT ALARM DURING TREATMENT. STAFF REPORTED THE MACHINE NEVER ALARMED AND BLOOD PUMP DID NOT STOP. THE TREND FILE WAS CAPTURED AND WAS PROVIDED FOR EVALUATION. UPON REVIEW OF THE TREND DATA, IT WAS CONFIRMED THAT THE DEVICE DID ALARM FOR VENOUS PRESSURE. A SAFETY INSPECTION PERFORMED ON THE DEVICE SHOWED NO ISSUES. THE PATIENT INVOLVED IN THE INCIDENT REQUIRED A BLOOD INFUSION AND WAS SENT TO THE EMERGENCY ROOM FOR TREATMENT AFTER THE EVENT. THE CUSTOMER ALSO CONFIRMED VIA ADDITIONAL INQUIRY THERE WAS NO SERIOUS INJURY AND NO PATIENT HARM WAS REPORTED AFTER THE INCIDENT. ESTIMATED TIME OF THE OCCURRENCE IS BETWEEN ONE HOUR AND THIRTEEN MINUTES AND ONE HOUR AND FOURTEEN MINUTES INTO THE INFUSION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 15665556 ↗
• MalfunctionOct 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE USER FACILITY: CUSTOMER REPORTED THAT THE PATIENT CODED ON THE MACHINE WHILE IN THERAPY.

  Patient problems: Arrhythmia; Bradycardia

  MAUDE report 15639634 ↗
• InjuryOct 20, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE USER FACILITY: CUSTOMER REPORTED THAT THE PATIENT CODED ON THE MACHINE WHILE IN THERAPY.

  Patient problems: Bradycardia

  MAUDE report 15639629 ↗
• DeathAug 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT A PATIENT CODED DURING A TREATMENT WITH A DIALOG+ DIALYSIS MACHINE AND PASSED AWAY. AS PER FACILITY POLICY THE CUSTOMER REQUESTED AN EVALUATION OF THE DIALYSIS MACHINE BY THE MANUFACTURER. THE FEMALE PATIENT WAS A 74 YEAR OLD WITH A HISTORY OF HYPERTENSION, DIABETES, AND END-STAGE RENAL DISEASE PRESENTED DUE TO GENERALIZED WEAKNESS AND ELEVATED BLOOD PRESSURE. DURING LIVER FUNCTION TESTS (LFTS) INCREASED PARAMETERS WERE NOTED. SHE WAS EVENTUALLY FOUND TO HAVE ACUTE CHOLECYSTITIS AND UNDERWENT SURGERY ON (B)(6). THE PATIENT WAS ON DIALYSIS FOR 2.5 HOURS. SHE WAS LETHARGIC BUT AROUSABLE AND CONVERSANT WITH A BLOOD PRESSURE OF 118/60 AT 20:25. AT 20:55 THE STAFF WAS UNABLE TO OBTAIN A BLOOD PRESSURE AND THE PATIENT WAS UNRESPONSIVE WITH SHALLOW AND SLOW RESPIRATORY RATE. THE STAFF AUSCULTATED A FAINT HEARTBEAT. THE PATIENT WAS PLACE IN TRENDELENBURG POSITION, TREATMENT WAS STOPPED, AND HER BLOOD WAS RETURNED TO HER ALONG WITH AN ADDITION OF 200 ML NORMAL SALINE. RRT WAS CALLED. RRT WAS ALSO ABLE TO AUSCULTATE A FAINT HEARTBEAT. PATIENT WAS AN ALLOW NATURAL DEATH, SO CPR WAS NOT INITIATED. CAUSE OF DEATH: CARDIOPULMONARY ARREST. TH

  Patient problems: Cardiac Arrest

  MAUDE report 15209399 ↗
• DeathAug 11, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT A PATIENT CODED DURING A TREATMENT WITH A DIALOG+ DIALYSIS MACHINE AND PASSED AWAY. AS PER FACILITY POLICY THE CUSTOMER REQUESTED AN EVALUATION OF THE DIALYSIS MACHINE BY THE MANUFACTURER. THE FEMALE PATIENT WAS A 74 YEAR OLD WITH A HISTORY OF HYPERTENSION, DIABETES, AND END-STAGE RENAL DISEASE PRESENTED DUE TO GENERALIZED WEAKNESS AND ELEVATED BLOOD PRESSURE. DURING LIVER FUNCTION TESTS (LFTS) INCREASED PARAMETERS WERE NOTED. SHE WAS EVENTUALLY FOUND TO HAVE ACUTE CHOLECYSTITIS AND UNDERWENT SURGERY ON JULY 12TH. THE PATIENT WAS ON DIALYSIS FOR 2.5 HOURS. SHE WAS LETHARGIC BUT AROUSABLE AND CONVERSANT WITH A BLOOD PRESSURE OF 118/60 AT 20:25. AT 20:55 THE STAFF WAS UNABLE TO OBTAIN A BLOOD PRESSURE AND THE PATIENT WAS UNRESPONSIVE WITH SHALLOW AND SLOW RESPIRATORY RATE. THE STAFF AUSCULTATED A FAINT HEARTBEAT. THE PATIENT WAS PLACE IN TRENDELENBURG POSITION, TREATMENT WAS STOPPED, AND HER BLOOD WAS RETURNED TO HER ALONG WITH AN ADDITION OF 200 ML NORMAL SALINE. RRT WAS CALLED. RRT WAS ALSO ABLE TO AUSCULTATE A FAINT HEARTBEAT. PATIENT WAS AN ALLOW NATURAL DEATH, SO CPR WAS NOT INITIATED. CAUSE OF DEATH: CARDIOPULMONARY ARREST.

  Patient problems: Cardiac Arrest

  MAUDE report 15209398 ↗
• DeathJul 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT A PATIENT CODED DURING A TREATMENT WITH A DIALOG+ DIALYSIS MACHINE AND PASSED AWAY. AS PER FACILITY POLICY THE CUSTOMER REQUESTED AN EVALUATION OF THE DIALYSIS MACHINE BY THE MANUFACTURER. THE CUSTOMER DESCRIBED THE INCIDENT IN MORE DETAIL AS FOLLOWS. ABOUT 46 MINUTES INTO THERAPY, THE PATIENT DEVELOPED SHORTNESS OF BREATH. OXYGEN (2L/NC) AND SALINE WAS ADMINISTERED AND THE DIALYSIS TREATMENT WAS DISCONTINUED. SINCE THE SYMPTOMS DID NOT RESOLVE, OXYGEN WAS INCREASED FROM 2 TO 10L VIA MASK AND THE RAPID RESPONSE TEAM WAS CALLED. THE PATIENT BECAME UNRESPONSIVE AND CONTINUED TO DETERIORATE. THE MD WHO WAS CALLED PRONOUNCED THE PATIENT HEAD. THE PATIENT HAD A DNR ORDER. THE CUSTOMER STATED THAT THERE WAS NO INDICATION OF A MALFUNCTION OF THE DIALOG+ MACHINE. THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL, INC. INTERNAL REPORT NUMBER (B)(4).

  Patient problems: Cardiac Arrest; Dyspnea

  MAUDE report 15078165 ↗
• DeathJul 21, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT A PATIENT CODED DURING A TREATMENT WITH A DIALOG+ DIALYSIS MACHINE AND PASSED AWAY. AS PER FACILITY POLICY THE CUSTOMER REQUESTED AN EVALUATION OF THE DIALYSIS MACHINE BY THE MANUFACTURER. THE CUSTOMER DESCRIBED THE INCIDENT IN MORE DETAIL AS FOLLOWS. ABOUT 46 MINUTES INTO THERAPY, THE PATIENT DEVELOPED SHORTNESS OF BREATH. OXYGEN (2L/NC) AND SALINE WAS ADMINISTERED AND THE DIALYSIS TREATMENT WAS DISCONTINUED. SINCE THE SYMPTOMS DID NOT RESOLVE, OXYGEN WAS INCREASED FROM 2 TO 10L VIA MASK AND THE RAPID RESPONSE TEAM WAS CALLED. THE PATIENT BECAME UNRESPONSIVE AND CONTINUED TO DETERIORATE. THE MD WHO WAS CALLED PRONOUNCED THE PATIENT HEAD. THE PATIENT HAD A DNR ORDER. THE CUSTOMER STATED THAT THERE WAS NO INDICATION OF A MALFUNCTION OF THE DIALOG+ MACHINE.

  Patient problems: Cardiac Arrest; Dyspnea

  MAUDE report 15078106 ↗
• MalfunctionJun 1, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AS REPORTED BY THE USER FACILITY: IT WAS REPORTED THAT A VENOUS NEEDLE DISLODGED WITHOUT ALARM DURING TREATMENT. STAFF REPORTED THE MACHINE NEVER ALARMED AND BLOOD PUMP DID NOT STOP. THE TREND FILE WAS CAPTURED AND WAS PROVIDED FOR EVALUATION. UPON REVIEW OF THE TREND DATA, IT WAS CONFIRMED THAT THE DEVICE DID ALARM FOR VENOUS PRESSURE. A SAFETY INSPECTION PERFORMED ON THE DEVICE SHOWED NO ISSUES. THE PATIENT INVOLVED IN THE INCIDENT REQUIRED A BLOOD INFUSION AND WAS SENT TO THE EMERGENCY ROOM FOR TREATMENT AFTER THE EVENT. THE CUSTOMER ALSO CONFIRMED VIA ADDITIONAL INQUIRY THERE WAS NO SERIOUS INJURY AND NO PATIENT HARM WAS REPORTED AFTER THE INCIDENT. ESTIMATED TIME OF THE OCCURRENCE IS BETWEEN ONE HOUR AND THIRTEEN MINUTES AND ONE HOUR AND FOURTEEN MINUTES INTO THE INFUSION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 14565054 ↗

Recalls under the same FDA submission

These recalls involve devices cleared under K083460, K963440. One submission often covers many models, so check the product and lot details in each record.

• Z-0872-2022 · Jan 28, 2022 · Terminated
  Conductivity Sensors utilized on Dialog and Dialog+ Hemodialysis Systems. Conductivity Sensor (BIC) - VERSION 2, Article Code Number 3456102A. These conductivity sensors may be us
• Z-0873-2022 · Jan 28, 2022 · Terminated
  Conductivity Sensors utilized on Dialog and Dialog+ Hemodialysis Systems. Conductivity Sensor (END) - VERSION 2, Article Code Number 3456103A. These conductivity sensors may be us
• Z-1531-2016 · Apr 1, 2016 · Terminated
  Dialog+ Hemodialysis machines: Dialog A + HE/BIC Product Code 710200L Serial # >200318 and < 2039222 The Dialog+ can be used for implementing and monitoring hemodialysis treatments
• Z-1532-2016 · Apr 1, 2016 · Terminated
  Dialog+ Hemodialysis machines: Dialog A + 1 Blood Pump 120V Product Code 710200K Serial # >202169 and < 203249 The Dialog+ can be used for implementing and monitoring hemodialysis
• Z-1534-2016 · Apr 1, 2016 · Terminated
  Dialog+ Hemodialysis machines: Dialog + 120 V DF+Adimea+WAN-BSL-BIC Product Code # 710200U Serial # 202136 and < 203837 The Dialog+ can be used for implementing and monitoring hemo
• Z-1533-2016 · Apr 1, 2016 · Terminated
  Dialog+ Hemodialysis machines: Dialog + 120 V DF+Adimea+WAN-BSL Product Code # 710200S Serial # >200805 and <204001 The Dialog+ can be used for implementing and monitoring hemodial
• Z-1535-2016 · Apr 1, 2016 · Terminated
  Dialog+ Hemodialysis machines: Conductivity Sensor (BIC) Item # 3456102A The Dialog+ can be used for implementing and monitoring hemodialysis treatments for patients with acute or
• Z-1536-2016 · Apr 1, 2016 · Terminated
  Dialog+ Hemodialysis machines: Conductivity Sensor (BIC) Item 3456103A The Dialog+ can be used for implementing and monitoring hemodialysis treatments for patients with acute or ch