Dialog+® 710200SRecalls & reported problems
B.Braun Avitum AG · Dialog + 120 V DF+Adimea+WAN-BSL+BIC · Class 2
- Adverse event reports
- 17
- Deaths reported
- 11
- Injuries reported
- 6
- Recalls naming it
- 0
Summary
The FDA's MAUDE database contains 17 adverse event reports that list this exact device (DI 04046964285608), received between Oct 27, 2017 and Oct 22, 2025 — classified as 11 deaths, 6 injuries.
The most frequently reported specific device problem is “Defective Alarm” (1 report).
8 other recalls cover devices cleared under the same FDA submission (K083460); 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.
Reports received per month
Most reported problems
Device problems
- Adverse Event Without Identified Device or Use Problem16
- Defective Alarm1
- Use of Device Problem1
Patient problems
- Cardiac Arrest7
- Death7
- Hemorrhage/Blood Loss/Bleeding3
- Loss of consciousness2
- Blood Loss1
- Insufficient Information1
- Low Blood Pressure/ Hypotension1
Recent adverse event reports
The 17 most recent of 17 reports, in the reporter's own words as published by the FDA.
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 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 ↗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 ↗DeathJun 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AS REPORTED BY USER FACILITY: THE VENOUS LINE DETACHED FROM THE CATHETER TWO (2) HOURS INTO TREATMENT CAUSING SIGNIFICANT BLOOD LOSS OF 500+ ML. THE VENOUS PRESSURE READING OF THE DIALYSIS MACHINE WAS AROUND 200 MMHG DURING TREATMENT AND THEN DROPPED RAPIDLY TO 40 MMHG WHEN THE VENOUS LINE DETACHED. SINCE THE LOWER ALARM LIMIT OF THE DIALOG+ MACHINE WAS SET TO 20 MMHG, IT DID NOT TRIGGER AN ALARM. THE NURSE RESPONDED WITHIN ONE (1) MINUTE OF THE PRESSURE DROP TO FIND THAT THE VENOUS LINE HAD BECOME DISCONNECTED. THE SITE WAS NOT COVERED. IT WAS IN PLAIN SIGHT. THE PATIENT RECEIVED CPR AND WAS TRANSPORTED TO THE HOSPITAL. THE PATIENT DID PASS AWAY SEVERAL DAYS LATER. PLEASE NOTE THAT THIS IS THE SAME PATIENT AND INCIDENT AS REPORTED IN MDR # 2521402-2021-00024.
Patient problems: Cardiac Arrest; Hemorrhage/Blood Loss/Bleeding
MAUDE report 11968052 ↗DeathJun 9, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AS REPORTED BY USER FACILITY: THE VENOUS LINE DETACHED FROM THE CATHETER TWO (2) HOURS INTO TREATMENT CAUSING SIGNIFICANT BLOOD LOSS OF 500+ ML. THE VENOUS PRESSURE READING OF THE DIALYSIS MACHINE WAS AROUND 200 MMHG DURING TREATMENT AND THEN DROPPED RAPIDLY TO 40 MMHG WHEN THE VENOUS LINE DETACHED. SINCE THE LOWER ALARM LIMIT OF THE DIALOG+ MACHINE WAS SET TO 20 MMHG, IT DID NOT TRIGGER AN ALARM. THE NURSE RESPONDED WITHIN ONE (1) MINUTE OF THE PRESSURE DROP TO FIND THAT THE VENOUS LINE HAD BECOME DISCONNECTED. THE SITE WAS NOT COVERED. IT WAS IN PLAIN SIGHT. THE PATIENT RECEIVED CPR AND WAS TRANSPORTED TO THE HOSPITAL. THE PATIENT DID PASS AWAY SEVERAL DAYS LATER. PLEASE NOTE THAT THIS IS THE SAME PATIENT AND INCIDENT AS REPORTED IN MDR # 2521402-2021-00024. ADDITIONAL IMPORTER NARRATIVE: THE DIALOG+ DIALYSIS MACHINE WAS TECHNICALLY INSPECTED BY THE CUSTOMER'S TECHNICIAN AFTER THE DESCRIBED EVENT. IT WAS CONFIRMED THAT IT OPERATED AS INTENDED AND HAS BEEN CLEARED FOR USE BY THE CUSTOMER. DEPENDENT ON THE PRESSURE DROP AND THE ALARM LIMITS SET, THE PRESSURE MONITORING SYSTEM OF A DIALYSIS MACHINE DOES NOT RELIABLY DETECT A DISCONNECTION OR DISLODGEMENT OF THE VENOUS PATIENT ACCESS
Patient problems: Cardiac Arrest; Hemorrhage/Blood Loss/Bleeding
MAUDE report 11968048 ↗InjuryOct 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AS REPORTED BY USER FACILITY: THERE WAS A PATIENT THAT WENT UNRESPONSIVE AT THE END OF A THERAPY WITH A DIALOG+ DIALYSIS MACHINE. THE PATIENT CAME BY WHEELCHAIR. THE STAFF REMARKED HOW HE NORMALLY WALKED IN THE CLINIC. THE PATIENT SAID THAT HE HAD NOT FELT VERY GOOD AFTER STARTING A NEW SHINGLES MEDICATION. TOWARD THE END OF THE TREATMENT THE PATIENT WENT UNRESPONSIVE, STAFF BEGAN CPR AND THE PATIENT WAS TRANSPORTED TO THE EMERGENCY ROOM BY AMBULANCE.
Patient problems: Loss of consciousness
MAUDE report 10684401 ↗InjuryOct 15, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AS REPORTED BY USER FACILITY: IT WAS REPORTED THAT A PATIENT WENT UNRESPONSIVE AT THE END OF A THERAPY WITH A DIALOG+ DIALYSIS MACHINE. THE PATIENT CAME BY WHEELCHAIR. THE STAFF REMARKED HOW HE NORMALLY WALKED IN THE CLINIC. THE PATIENT SAID THAT HE HAD NOT FELT VERY GOOD AFTER STARTING A NEW SHINGLES MEDICATION. TOWARD THE END OF THE TREATMENT THE PATIENT WENT UNRESPONSIVE, STAFF BEGAN CPR AND THE PATIENT WAS TRANSPORTED TO THE EMERGENCY ROOM BY AMBULANCE.
Patient problems: Loss of consciousness
MAUDE report 10684394 ↗DeathAug 26, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AS REPORTED BY USER FACILITY: BIO-MED REPORTED A PATIENT CODED AND PASSED AWAY DURING A TREATMENT. BIO-MED VERIFIED ALL THE MACHINE SAFETY CALIBRATIONS AND AT THE TIME OF THE INCIDENT THE DIALOG MACHINE WAS OPERATING WITHIN SPECIFIED LIMITS AND TOLERANCES.
Patient problems: Death
MAUDE report 10454479 ↗DeathAug 26, 2020Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
THIS REPORT HAS BEEN IDENTIFIED AS B. BRAUN MEDICAL INC. INTERNAL REPORT#: (B)(4). THIS FOLLOW-UP REPORT IS BEING FILED FOR CORRECTIONS. SECTION B2 HAS BEEN CHANGED. IF ADDITIONAL PERTINENT INFORMATION BECOMES AVAILABLE A FOLLOW-UP REPORT WILL BE FILED.
Patient problems: Death; Insufficient Information
MAUDE report 10454476 ↗DeathJan 30, 2019Adverse 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 EXPIRED WHILE ON THE MACHINE HAVING A TREATMENT. THE TECHNICIAN INDICATED THAT THE MACHINE WAS RUNNING FINE AND HAD NOTHING TO DO WITH THE PATIENT EXPIRING. UPDATED INFORMATION WAS RECEIVED THAT THE PATIENT DID NOT EXPIRE ON THE MACHINE. THE PATIENT CODED DURING DIALYSIS WHILE CONNECTED TO THE MACHINE. THE PATIENT WAS EXTREMELY SICK AND HAD MULTIPLE COMORBIDITIES. THE MACHINE FUNCTIONED PROPERLY. NO PATIENT INFORMATION WAS PROVIDED.
Patient problems: Death
MAUDE report 8288804 ↗DeathSep 13, 2018Adverse 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 WHILE BEING DIALYZED 15 MINUTES INTO THE TREATMENT. IT WAS REPORTED THERE WERE NO ALARMS THAT SOUNDED AND THE CUSTOMER DENIES ANY DISCONNECTIONS OR ANY OTHER COMPLICATIONS WITH THE DIALOG MACHINE AND COMPONENTS. PATIENT, MALE, (B)(6), BEGAN OUTPATIENT CLINIC WITH ON (B)(6) 2018. DIALYSIS ORDERED THREE (3) TIMES A WEEK - MONDAY, WEDNESDAY AND FRIDAY. PATIENT CAME IN (B)(6) 2018 FOR SCHEDULED DIALYSIS. PATIENT WALKED IN WITH WALKER, HAVING SHORTNESS OF BREATH WHEN AMBULATING, AND SITTING OFTEN WHEN WALKING IN. PATIENT DISCLOSED TO CLINICIAN THAT HE DRANK EXCESSIVE FLUIDS OVER THE WEEKEND, NOT COMPLYING WITH HIS FLUID RESTRICTION. (B)(6). PATIENT WAS BROUGHT INTO DIALYSIS ROOM AND VITALS WERE OBTAINED. ALL WERE WITHIN NORMAL LIMITS. BLOOD PRESSURE (BP) WAS 120/70 AVERAGE, AFEBRILE, APPEARANCE AND COLOR WELL. THE FACILITY DOES NOT ASSESS OXYGEN LEVELS OR HAVE CAPABILITIES TO DO SO. PATIENT PRESENTED EDEMA IN UPPER AND LOWER EXTREMITIES. PATIENT DENIED ANY PAIN. DIALYSIS SET UP AND STARTED AS ORDERED. WITHIN 10-15 MINUTES OF TREATMENT, THE CLINICIAN STATED THE PATIENT SAT STRAIGHT UP AND SAID "I CANNOT BREATHE!" CLIN
Patient problems: Death
MAUDE report 7872673 ↗DeathSep 13, 2018Adverse 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 A PATIENT WAS STARTED ON ONE DIALYSIS MACHINE AND A BLOOD LEAK WAS NOTED. THE PATIENT WAS MOVED TO A SECOND MACHINE WHEN SHE STARTED NOT TO FEEL WELL. PATIENT WENT TO THE BATHROOM BUT DID NOT COME OUT. THE NURSE OPENED THE BATHROOM DOOR AND FOUND THE PATIENT UNRESPONSIVE ON THE FLOOR. 911 WAS CALLED AND CPR/AED WAS STARTED. AED STATED SHOCK WAS NOT ADVISED. EMS ARRIVED IN LESS THAN TWO (2) MINUTES AND EMS WAS UNABLE TO GET THE PATIENT TO RESPOND. THE PATIENT WAS A (B)(6) YEAR OLD FEMALE WITH SIGNIFICANT MEDICAL HISTORY: SEVERE HYPERTENSION, TYPE 2 DIABETES, AND SIGNIFICANT CARDIAC HISTORY. NO AUTOPSY WAS PERFORMED. THE CAUSE OF DEATH WAS SUDDEN CARDIAC DEATH. THE PATIENT WAS NOT ATTACHED TO THE MACHINE AT THE TIME OF THE INCIDENT. THE FACILITY'S BIOMED AND RISK MANAGEMENT DID CLEAR MACHINE, HOWEVER THE FACILITY IS KEEPING THE MACHINE OUT OF SERVICE UNTIL THE FINAL REPORT IS RECEIVED FROM B. BRAUN. THE CUSTOMER DID MENTION THAT THEY FEEL THAT THE BP READINGS ARE HIGHER THAN NORMAL. A SYSTEM CHECK OUT HAS BEEN COMPLETED BY THE CLINIC'S BIOMED. CONDUCTIVITY, TEMPERATURE AND UF HAVE BEEN VERIFIED AND TESTED PER THE MANUFA
Patient problems: Death
MAUDE report 7872668 ↗DeathSep 13, 2018Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem
AS REPORTED BY THE USER FACILITY: CUSTOMER REPORTED THAT APPROXIMATELY 20 MINUTES AFTER THE START OF THERAPY, THE PATIENT'S BLOOD PRESSURE DROPPED AND THE PATIENT BECAME UNRESPONSIVE. THE LOW BLOOD PRESSURE ALARM WAS ACTIVATED. THE PATIENT'S BLOOD PRESSURE WAS 67/45 AND THE NURSE ADMINISTERED A BOLUS OF IV FLUID AND STARTED OXYGEN THERAPY. THE PATIENT'S BLOOD PRESSURE INCREASED TO 112/75 AND THE PATIENT STILL REMAINED UNRESPONSIVE; EVEN AFTER STERNAL RUB. EMS WAS CALLED TO THE FACILITY. THE PATIENT WAS A DNR SO CPR WAS NOT STARTED. EMS TOOK PATIENT TO HOSPITAL WHERE HE WAS PRONOUNCED DEAD. NO AUTOPSY WAS PERFORMED. NO CAUSE OF DEATH PROVIDED. PATIENT WAS A (B)(6) MALE WITH SIGNIFICANT MEDICAL HISTORY. PATIENT HAD A MASSIVE STROKE OVER A YEAR AGO. PATIENT WAS CONSTANTLY UNDER SEDATION AT HIS NURSING HOME RESIDENCE; HENCE THE NURSE SAID HE WAS "NORMALLY" UNRESPONSIVE. PATIENT ALSO TYPICALLY HAD A LOW BP DURING THERAPY. THE EVENT OCCURRED DURING THERAPY AND THE THERAPY WAS NOT COMPLETED. CUSTOMER STATED MACHINE IS OUT OF SERVICE UNTIL FINAL REPORT IS PROVIDED. CUSTOMER DOES FEEL THE BLOOD PRESSURE READING IS HIGHER THAN NORMAL. A SYSTEM CHECK OUT HAS BEEN COMPLETED BY THE CLINIC'S BIO
Patient problems: Death
MAUDE report 7872666 ↗DeathMar 15, 2018Adverse 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 ON A MACHINE. THE PARAMEDICS WERE CALLED TO THE SCENE AND CPR WAS ADMINISTERED. THE PATIENT IS DECEASED. THE CUSTOMER IS RELUCTANT TO GIVE ANY INFORMATION BEFORE SPEAKING TO HIS RISK DEPARTMENT. HE STATED,"THE DEATH IS NOT BECAUSE OF THE MACHINE SO WHY DO YOU NEED THE INFORMATION? HAVE YOU EVER CALLED A DAVITA AND ASKED THIS INFORMATION IN THE PAST? I WILL NEED TO SPEAK WITH RISK MANAGEMENT BEFORE I GIVE ANYTHING ELSE OUT. I AM NOT TRYING TO MAKE YOUR JOB HARDER BUT I WANT TO BE CAREFUL."IT WAS INDICATED THAT THERE WAS MINIMAL DOCUMENTATION DONE DURING THE TIME OF THE EVENT IN (B)(6), 2018. WHEN ASKED FOR PATIENT VITAL SIGNS, ETC, IT WAS STATED THIS IS WHY B. BRAUN WAS CONTACTED TO PULL THAT INFORMATION FROM THE LOGS. THE PATIENT WAS A FEMALE BORN IN (B)(6) 1932. SHE WAS PRONOUNCED AT THE HOSPITAL AFTER CPR WAS STARTED IN THE FACILITY BY STAFF. PARAMEDICS WERE CALLED AND TOOK OVER CARE AND TRANSPORTED TO THE HOSPITAL. THE EVENT OCCURRED AFTER THERAPY WAS OVER AND AFTER RINSE BACK WAS COMPLETED.
Patient problems: Death
MAUDE report 7342814 ↗InjuryJan 24, 2018Defective Alarm; Defective Alarm
AS REPORTED BY THE USER FACILITY: REPORTED THAT DURING A THERAPY THE VENOUS ACCESS BECAME DISLODGED FROM THE PATIENT ACCESS AND THE MACHINE DID NOT ALARM. THE NURSE CALLED PARAMEDICS DUE TO BLOOD LOSS AND HYPOTENSION.
Patient problems: Blood Loss; Low Blood Pressure/ Hypotension
MAUDE report 7214888 ↗InjuryOct 27, 2017Use of Device Problem; Adverse Event Without Identified Device or Use Problem; Use of Device Problem; Adverse Event Without Identified Device or Use Problem
AS REPORTED BY THE USER FACILITY: PATIENT HAD A CARDIAC ARREST ON THE MACHINE DURING THERAPY AND THAT IN THE PROCESS OF TESTING THE DIALYSATE ELECTROLYTES IT WAS DISCOVERED THAT THE RESULTS WHERE OFF FROM WHAT WAS EXPECTED BY THE CUSTOMER. IT SHOULD BE NOTED THAT THE CONDUCTIVITY AND TEMPERATURE WHERE REPORTED TO BE WITHIN TOLERANCE. PATIENT HAD CARDIAC ARREST DURING TREATMENT. THE THERAPY WAS STOPPED. THE PATIENT WAS SENT TO THE EMERGENCY ROOM AND RELEASED 48 HOURS LATER AS REPORTED BY THE CALLER. PATIENT WAS A 69 YEAR OLD MALE WHO CAME TO THE FACILITY FOR HIS TREATMENT AS SCHEDULED ON (B)(6) 2017. PT WEIGHT WAS 89.9KG BEFORE TREATMENT WITH THE TARGET WT OF 84.5KG. THE PATIENT HAD A CVC FOR DIALYSIS. NO LABS TO REPORT AS LABS ARE DONE ON A MONTHLY BASIS AND THE WEEK OF THE EVENT WAS NOT A "LAB WEEK". THE DIALYSIS ORDER FOR THE PATIENT ON (B)(6) 2017 WAS AS FOLLOWS: 240 MINS, BLOOD FLOW RATE 300ML/HR, DIALYSATE FLOW RATE 600ML/HR, TEMP 36 DEGREES, 3K BATH, HEPARIN BOLUS 1000UNITS, HEPARIN MAINTENANCE 1000 UNITS/HR, BICARB 40. THE PATIENTS VITALS BEFORE CARDIAC ARREST AT THE START OF HIS DIALYSIS TREATMENT WERE BP-180/66 SITTING, PULSE-65, TEMP-96 DEGREES F. THE PATIENTS VITALS RIGH
Patient problems: Cardiac Arrest
MAUDE report 6983820 ↗
Recalls under the same FDA submission
These recalls involve devices cleared under K083460. One submission often covers many models, so check the product and lot details in each record.
- Z-0872-2022 · Jan 28, 2022 · TerminatedConductivity 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 · TerminatedConductivity Sensors utilized on Dialog and Dialog+ Hemodialysis Systems. Conductivity Sensor (END) - VERSION 2, Article Code Number 3456103A. These conductivity sensors may be us
- Z-1536-2016 · Apr 1, 2016 · TerminatedDialog+ Hemodialysis machines: Conductivity Sensor (BIC) Item 3456103A The Dialog+ can be used for implementing and monitoring hemodialysis treatments for patients with acute or ch
- Z-1532-2016 · Apr 1, 2016 · TerminatedDialog+ 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-1535-2016 · Apr 1, 2016 · TerminatedDialog+ Hemodialysis machines: Conductivity Sensor (BIC) Item # 3456102A The Dialog+ can be used for implementing and monitoring hemodialysis treatments for patients with acute or
- Z-1533-2016 · Apr 1, 2016 · TerminatedDialog+ 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-1534-2016 · Apr 1, 2016 · TerminatedDialog+ 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-1531-2016 · Apr 1, 2016 · TerminatedDialog+ Hemodialysis machines: Dialog A + HE/BIC Product Code 710200L Serial # >200318 and < 2039222 The Dialog+ can be used for implementing and monitoring hemodialysis treatments
Other Dialyzer, high permeability with or without sealed dialysate system devices
- Optiflux® 0500318EFresenius Medical Care Holdings, Inc. · Dialyzer, high permeability with or without sealed dialysate system1 recall6 deaths2,849 reports
- 2008® Series Hemodialysis Machines 190713Fresenius Usa, Inc. · Dialyzer, high permeability with or without sealed dialysate system3 recalls37 deaths893 reports
- 2008T BlueStar Hemodialysis Machine 191126Fresenius Medical Care Holdings, Inc. · Dialyzer, high permeability with or without sealed dialysate system5 recalls10 deaths441 reports
- 2008® Series Hemodialysis Machines 190766Fresenius Usa, Inc. · Dialyzer, high permeability with or without sealed dialysate system4 recalls15 deaths370 reports
- 2008T BlueStar Hemodialysis Machine 191130Fresenius Medical Care Holdings, Inc. · Dialyzer, high permeability with or without sealed dialysate system4 recalls7 deaths272 reports
- 2008® Series Hemodialysis Machines 190610Fresenius Usa, Inc. · Dialyzer, high permeability with or without sealed dialysate system1 recall15 deaths335 reports
- Optiflux® 0500320EFresenius Medical Care Holdings, Inc. · Dialyzer, high permeability with or without sealed dialysate system2 recalls242 reports
- REVACLEAR 300Gambro Renal Products, Inc. · Dialyzer, high permeability with or without sealed dialysate system3 recalls125 reports
Sources: FDA GUDID, MAUDE and Medical Device Recalls via openFDA. openFDA data is not validated for clinical or regulatory use.