Tablo(R) Hemodialysis System PN-0003000Recalls & reported problems

Summary

The FDA's MAUDE database contains 83 adverse event reports that list this exact device (DI 00850001011112), received between Jun 11, 2019 and Sep 26, 2026 — classified as 34 deaths, 47 injuries, 2 malfunctions.

The most frequently reported specific device problem is “Calibration Problem” (3 reports).

3 FDA recall records name this device's identifier, 3 still open.

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 18, 2026.

Recalls naming this device

1. Aug 1, 2024Class IIOpen, Classified

   Blood leak sensor, a component of hemodialysis device, may show decreased sensitivity, at the lowest level, specified as 0.35 mL/min blood leak rate, which could delay triggering the ALARM_DIALYZER_BLOOD_LEAK alarm, if blood loss, less-than 300ml, occurs, the patient may experience hypotension, fatigue, cramps, dizziness, headaches, nausea, and shortness of breath.

   Z-0019-2025 · Root cause: Nonconforming Material/Component · Recall details · FDA record ↗

2. Mar 6, 2024Class IOpen, Classified

   Hemodialysis System, pre and post dialyzer peroxide-cured silicone tubing, with less than 336 hours usage, will be replaced because tubing may contain non-dioxin-like (NDL) polychlorinated biphenyl acids (PCBAs), that have not been flushed out over time with usage. Exposure to PCBAs could cause: skin conditions, liver damage, impaired reproduction, development of certain kinds of cancer in humans.

   Z-1485-2024 · Root cause: Device Design · Recall details · FDA record ↗

3. Jan 20, 2022Class IIOpen, Classified

   Due to a component in the hemodialysis console there is the possibility of heat-related damage that may occur with the device.

   Z-0813-2022 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 83 reports, in the reporter's own words as published by the FDA.

• MalfunctionSep 26, 2026Thermal Decomposition of Device

  It was reported that there was a burnt power cord during idle mode. No patient was involved.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 50906572 ↗
• DeathSep 25, 2026Adverse Event Without Identified Device or Use Problem

  It was reported that 2 hours and 38 minutes into dialysis treatment, the treatment was ended due to patient's drop in blood pressure and code team was called. Cardiopulmonary resuscitation (CPR) was initiated, despite medical intervention, the patient expired. The treating team attributed the event to the patient's preexisting conditions. No alleged Tablo malfunction was reported or identified.

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 50893047 ↗
• DeathSep 4, 2026Adverse Event Without Identified Device or Use Problem

  A 67-year-old female patient who was ventilator and in critical condition underwent dialysis treatment. Treatment was initiated at approximately 1215 hours. During treatment the patient coded, blood was successfully returned to the patient, Cardiopulmonary resuscitation (CPR) performed, including administration of sodium bicarbonate Despite these efforts, the patient expired.

  Patient problems: Insufficient Information

  MAUDE report 50620879 ↗
• InjuryJan 30, 2026Adverse Event Without Identified Device or Use Problem

  BIOMED CALLED TO REPORT A DIALYZER BLOOD LEAK DURING TREATMENT. REGISTERED NURSE (RN) USER REPORTED THAT WHEN ALARM OCCURRED, TEST STRIP WAS NOT USED TO CONFIRM THE BLOOD LEAK AS THE NURSE DID NOT HAVE ANY TEST STRIP WITH HER. ALARM OCCURRED TWICE, AND THERE WAS A LOSS OF 400ML BLOOD. THE PATIENT IS STABLE AND THERE WAS NO ALLEGED MALFUNCTION OF TABLO.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24228113 ↗
• InjuryJan 14, 2026Fluid/Blood Leak

  IT WAS REPORTED THAT THERE WAS A BLOOD LINE LEAK ALARM DURING PATIENT TREATMENT. BLOOD STRIPS DID CONFIRM THAT THERE WAS A LEAK. BLOOD WAS DISCARDED TWICE DURING TREATMENT, RESULTING IN AN ESTIMATE OF 600 ML BLOOD LOSS. NO PATIENT ADVERSE EVENT WAS NOTED AS A RESULT OF THIS INCIDENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 24067640 ↗
• InjuryJan 2, 2026Air/Gas in Device

  IT WAS REPORTED THAT THERE WAS AIR IN VENOUS BLOODLINE ALARM DURING PATIENT TREATMENT. NURSE CONFIRMED VISIBLE AIR AND TERMINATED TREATMENT. BLOOD WAS DISCARDED TWICE DURING TREATMENT, RESULTING IN AN ESTIMATE OF 600 ML BLOOD LOSS. PATIENT COMPLETED TREATMENT SUCCESSFULLY ON ANOTHER TABLO. NO PATIENT ADVERSE EVENT WAS NOTED AS A RESULT OF THIS INCIDENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 23952216 ↗
• InjuryAug 29, 2025Use of Device Problem; Adverse Event Without Identified Device or Use Problem; Use of Device Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE VENOUS NEEDLE DISLODGED FROM THE PATIENT DURING TREATMENT. PATIENT TREATMENT DISCONTINUED, AND THERE WAS AN ESTIMATE OF 500ML -700 ML BLOOD LOSS CAUSING PATIENT TO CODE. CARDIOPULMONARY RESUSCITATION (CPR) GIVING ALONG WITH PATIENT BEING SENT TO INTENSIVE CARE UNIT AND INTUBATED DUE TO BLOOD LOSS. BLOOD TRANSFUSION WAS GIVEN, AND THE PATIENT IS NOW STABLE.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 22926162 ↗
• InjuryApr 22, 2025Calibration Problem; Calibration Problem

  CUSTOMER SITE DIALYSIS NURSE MANAGER REPORTED THAT A PATIENT WENT TO THE EMERGENCY ROOM FOLLOWING HEMODIALYSIS THERAPY ON TABLO. THE FOLLOWING DETAILS WERE PROVIDED. THE PATIENT EXPERIENCED NAUSEA, DRY HEAVES, HEADACHE, DIZZINESS, AND SOME HEAD AND NECK PAIN AFTER 3.5 HOURS OF TREATMENT. FOLLOWING TREATMENT, THE PATIENT WAS ADMITTED TO THE EMERGENCY DEPARTMENT AND INTO THE INTENSIVE CARE UNIT. PATIENT STABILIZED AND MOVED TO REGULAR UNIT (B)(6) 2025. ADDITIONALLY, IT WAS REPORTED THAT THE PATIENT INVOLVED IS DOING FINE, HAS RECEIVED DIALYSIS TREATMENTS SINCE THE INCIDENT ON ANOTHER TABLO DEVICE.

  Patient problems: Dizziness; Headache; Nausea; Neck Pain

  MAUDE report 21883501 ↗
• InjuryApr 22, 2025Calibration Problem; Calibration Problem

  CUSTOMER SITE DIALYSIS NURSE MANAGER REPORTED THAT A PATIENT WENT TO THE EMERGENCY ROOM FOLLOWING HEMODIALYSIS THERAPY ON TABLO. THE FOLLOWING DETAILS WERE PROVIDED. THE PATIENT EXPERIENCED NAUSEA, VOMITING, AND CHILLS, ONE HOUR INTO TREATMENT. VITALS WERE FINE. FOLLOWING TREATMENT, THE PATIENT WAS SENT TO THE EMERGENCY ROOM. THE CUSTOMER SITE RAN ALL TESTS FOR INFECTION: COVID AND FLU; ALL CAME BACK NEGATIVE. THE PATIENT RECEIVED 1G OF VANCOMYCIN AND 2G OF FORTAZ AND THE PATIENT REPORTED SYMPTOM RELIEF FOLLOWING THE ADMINISTRATION OF VANCOMYCIN. THE PATIENT WAS LATER DISCHARGED HOME. ADDITIONALLY, IT WAS REPORTED THAT THE PATIENT INVOLVED IS DOING FINE AND HAS RECEIVED DIALYSIS TREATMENTS SINCE THE INCIDENT ON ANOTHER TABLO DEVICE.

  Patient problems: Chills; Nausea; Vomiting

  MAUDE report 21883473 ↗
• InjuryApr 22, 2025Calibration Problem; Calibration Problem

  CUSTOMER SITE DIALYSIS NURSE MANAGER REPORTED THAT A PATIENT WENT TO THE EMERGENCY ROOM FOLLOWING HEMODIALYSIS THERAPY ON TABLO. THE FOLLOWING DETAILS WERE PROVIDED. THE PATIENT EXPERIENCED NAUSEA, VOMITING, AND CHILLS, 1.5 HOURS INTO TREATMENT. VITALS WERE FINE. PATIENT ASKED TO BE TAKEN OFF TREATMENT. FOLLOWING TREATMENT, THE PATIENT WAS SENT TO THE EMERGENCY ROOM WHERE IT WAS DETERMINED THAT THE PATIENT HAD ELEVATED WHITE BLOOD COUNT. THE CUSTOMER SITE RAN ALL TESTS FOR INFECTION: COVID AND FLU; ALL CAME BACK NEGATIVE. THE PATIENT RECEIVED 1G OF VANCOMYCIN AND 2G OF FORTAZ AND THE PATIENT REPORTED SYMPTOM RELIEF FOLLOWING THE ADMINISTRATION OF VANCOMYCIN. THE PATIENT WAS LATER DISCHARGED HOME. ADDITIONALLY, IT WAS REPORTED THAT THE PATIENT INVOLVED IS DOING FINE AND HAS RECEIVED DIALYSIS TREATMENTS SINCE THE INCIDENT ON ANOTHER TABLO DEVICE WITHOUT A RECURRENCE OF EVENTS.

  Patient problems: Chills; Nausea; Vomiting

  MAUDE report 21883447 ↗
• InjuryJan 16, 2025Insufficient Device Problem Information; Insufficient Device Problem Information

  IT WAS REPORTED THAT THERE WAS A BLOOD DIALYSATE ALARM DURING TREATMENT. TREATMENT WAS ENDED AND THE USER NOTED THAT THEY DISCARDED BLOOD THREE TIMES RESULTING IN APPROXIMATELY 900ML BLOOD LOSS. THERE WAS NO PATIENT COMPLICATIONS REPORTED. MULTIPLE ATTEMPTS WERE MADE BY OUTSET CLINICAL SPECIALIST TO OBTAIN ADDITIONAL INFORMATION; HOWEVER, THE CUSTOMER DID NOT RESPOND.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 21170996 ↗
• InjuryDec 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT THE PATIENT BECAME SYMPTOMATIC DURING TREATMENT. THE NURSE STATED THAT THE CONSOLE WAS INITIALLY SET TO REMOVE A 2000ML GOAL BUT WAS ADJUSTED TO 1850ML DUE TO THE PATIENT FEELING UNWELL. HOWEVER, AFTER WEIGHING THE PATIENT, THE NURSE ALLEGED THAT 3300ML HAD ACTUALLY BEEN REMOVED, WHILE THE CONSOLE INDICATED ONLY 1850ML WAS REMOVED. THE PATIENT EXPERIENCED SEVERE CRAMPS AND CHEST PAIN, LEADING TO TRANSPORTATION TO THE EMERGENCY ROOM.

  Patient problems: Chest Pain; Cramp(s) /Muscle Spasm(s)

  MAUDE report 20909892 ↗
• InjuryOct 11, 2022Decreased Sensitivity; Decreased Sensitivity

  A HOME DIALYSIS PATIENT REPORTED THAT APPROXIMATELY 20 MINUTES INTO DIALYSIS TREATMENT; ALARM_DIALYZER_BLOOD_LEAK SOUNDED AND CAREGIVER/PATIENT VISUALIZED BLOOD IN DRAIN LINE AND PERFORMED EMERGENCY DISCONNECT. PATIENT STOOD UP AND LOST CONSCIOUSNESS AND WAS TAKEN TO HOSPITAL FOR EVALUATION. THE PATIENT WAS DISCHARGED FROM THE HOSPITAL THE FOLLOWING DAY. IT WAS ALSO REPORTED THAT THE DIALYZER (FRESENIUS F8 DIALYZER) MAY HAVE BEEN DAMAGED, HOWEVER, THE DIALYZER WAS DISCARDED AND THIS WAS NOT ABLE TO BE CONFIRMED.

  Patient problems: Loss of consciousness

  MAUDE report 15580747 ↗
• InjuryAug 30, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED BY THE NURSE THAT AN ALARM, DIALYZER_BLOOD_LEAK OCCURRED DURING A PATIENT TREATMENT. THE TREATMENT WAS ENDED AND THE NURSE COULD NOT RETURN THE PATIENT'S BLOOD AFTER NURSE CHECKED WITH BLOOD LEAK STRIPS AND IT WAS POSITIVE FOR BLOOD. A NEW TREATMENT WAS RESTARTED WITH A NEW CARTRIDGE. AGAIN, THE SAME ALARM OCCURRED A SECOND TIME AND THE TREATMENT ENDED AGAIN. THE NURSE WAS UNABLE TO RETURN THE PATIENT'S BLOOD A SECOND TIME, RESULTING IN BLOOD LOSS OF APPROXIMATELY 400ML IN TOTAL. IT WAS REPORTED THAT THE PATIENT CODED BETWEEN SWAPPING CARTRIDGES, THE CARE PERSONNEL INITIATED CARDIOPULMONARY RESUSCITATION (CPR) AND THE PATIENT WAS RESUSCITATED AND MOVED TO THE INTENSIVE CARE UNIT (ICU). PER THE INFORMATION RECEIVED FROM THE CUSTOMER SITE, IT IS UNKNOWN IF THE PATIENT CODING WAS RELATED TO TABLO OR PATIENT.

  Patient problems: Loss of consciousness

  MAUDE report 15321859 ↗
• InjuryNov 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A (B)(6) MALE PATIENT CODED DURING TREATMENT DUE TO A CARDIAC ARREST. THE TREATMENT STARTED AT 9:34 AM AND THE PATIENT CODED AT 7:01 PM. THE CLINICAL STAFF WAS ABLE TO END TREATMENT, RETURN BLOOD AND PERFORM CPR. THE PATIENT WAS RESUSCITATED AND THEN WAS INTUBATED. POST-TREATMENT, THE FAMILY THEN DECIDED TO EXTUBATE, AND THE PATIENT EXPIRED. IT WAS REPORTED THAT THE PATIENT CONDITION PRIOR TO TREATMENT WAS CRITICAL, HE WAS AN ICU PATIENT AND WAS SEPTIC. THE CLINICAL STAFF BELIEVES THAT THIS EVENT IS LIKELY PATIENT RELATED, DUE TO THE CRITICAL ICU PATIENT CONDITION, HOWEVER, THEY WERE NOT ABLE TO CONFIRM.

  Patient problems: Loss of consciousness

  MAUDE report 12837047 ↗
• InjuryOct 12, 2021No Display/Image; Failure to Power Up; No Display/Image; Failure to Power Up

  IT WAS REPORTED THAT A PATIENT WITH A HISTORY OF CARDIAC STENOSIS CODED TWICE DURING DIALYSIS TREATMENT ON TABLO. THE CARE PERSONNEL INITIATED CARDIOPULMONARY RESUSCITATION (CPR), AND THE PATIENT WAS REVIVED AND WAS STABLE. DURING THE SECOND CODE, THE CARE PERSONNEL ATTEMPTED TO RETURN THE BLOOD AND END THE TREATMENT; HOWEVER, IT WAS REPORTED THAT THE TABLO TOUCHSCREEN FROZE. THE NURSE DISCONNECTED THE PATIENT FROM THE TABLO DEVICE AND THERE WAS ESTIMATED 240 ML OF BLOOD LOSS. THE PATIENT WAS REVIVED AND WAS STABLE POST-TREATMENT. BASED ON THE AVAILABLE INFORMATION, IT IS UNKNOWN IF THE CODE EVENT WAS RELATED TO THE PATIENT¿S UNDERLYING CONDITION; THEREFORE, THIS EVENT IS BEING REPORTED AS A SERIOUS INJURY.

  Patient problems: Loss of consciousness

  MAUDE report 12619848 ↗
• MalfunctionSep 3, 2021Thermal Decomposition of Device; Fire; Melted; Thermal Decomposition of Device; Fire; Melted

  ON (B)(6) 2021, A FIRE EVENT INVOLVING A TABLO CONSOLE WAS REPORTED. AT THE TIME OF THE EVENT, THE TABLO CONSOLE HAD BEEN SITTING IDLE IN AN UNOCCUPIED STORAGE ROOM. THERE WAS NO PATIENT INVOLVEMENT OR REPORTED INJURIES BY THE HOSPITAL STAFF AS A RESULT OF THIS EVENT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 12425209 ↗
• InjuryApr 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY 15 MINUTES INTO A DIALYSIS TREATMENT, THE PATIENT CODED. IT WAS REPORTED THAT PRIOR TO THE DIALYSIS TREATMENT, THE PATIENT WAS ALREADY INTUBATED, SEDATED, HYPOTENSIVE AND HAD AN A-LINE THAT WAS READING VERY LOW (IN THE 60¿S). AT THIS POINT THE NURSE STOPPED ULTRAFILTRATION ON TABLO BUT THIS HAD NO EFFECT ON THE PATIENT¿S STABILITY. A CODE WAS CALLED AND THE CARE TEAM INITIATED CHEST COMPRESSIONS AND EPINEPHRINE WAS GIVEN PER ACLS PROTOCOL. THE PATIENT WAS REVIVED AND TRANSFERRED TO THE INTENSIVE CARE UNIT (ICU). BASED ON THE INFORMATION PROVIDED, THE CLINICAL STAFF DOES NOT BELIEVE THAT THE TABLO DEVICE CAUSED ON CONTRIBUTED TO THIS EVENT RATHER THIS EVENT WAS ATTRIBUTED TO THE PATIENT'S PRE-EXISTING CONDITIONS.

  Patient problems: Cardiac Arrest

  MAUDE report 11682557 ↗
• InjuryApr 16, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT APPROXIMATELY 1 HOUR AND 20 MINUTES INTO A 3 HOUR TREATMENT A PATIENT CODED. IT WAS REPORTED THAT THE PATIENT WAS IN THE INTENSIVE CARE UNIT (ICU) AND NEW TO DIALYSIS. IT WAS NOTED THAT THE PATIENT'S BLOOD PRESSURE WAS NORMAL WHEN TREATMENT BEGAN AND THEN WENT UP TO 154. THE PATIENT COMPLAINED OF CHEST PAIN AND BLOOD PRESSURE (BP) WENT UP TO 206/83 AND PULSE 113. THE TREATING TEAM INITIATED CARDIOPULMONARY RESUSCITATION (CPR) AND THE PATIENT WAS REVIVED. TACHYCARDIA WAS REPORTED TO HAVE CONTRIBUTED TO CARDIAC ARREST. TO NOTE, THE PATIENT WAS COVID NEGATIVE AT THE TIME OF THE CODE; HOWEVER, HE HAD BEEN COVID POSITIVE BEFORE AND HAD BEEN HOSPITALIZED FOR THIS REASON ALONG WITH HAVING PNEUMONIA. BASED ON THE INFORMATION PROVIDED, THE CLINICAL STAFF DOES NOT BELIEVE THAT THE TABLO DEVICE CAUSED OR CONTRIBUTED TO THE EVENT RATHER THIS EVENT WAS ATTRIBUTED TO THE PATIENT'S PRE-EXISTING CONDITIONS.

  Patient problems: Cardiac Arrest; Chest Pain

  MAUDE report 11681122 ↗
• InjuryApr 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT 10 MINUTES INTO DIALYSIS TREATMENT, THE PATIENT CODED. DIALYSIS TREATMENT WAS STOPPED AS CARE TEAM INITIATED CHEST COMPRESSIONS, ADMINISTERED EPINEPHRINE AND THE PATIENT REVIVED. PATIENT WAS STABLE AFTER BEING REVIVED. BASED ON THE INFORMATION PROVIDED, THE CLINICAL STAFF DOES NOT BELIEVE THAT THE TABLO DEVICE CAUSED THE EVENT RATHER THIS EVENT WAS ATTRIBUTED TO THE PATIENT'S PRE-EXISTING CONDITIONS.

  Patient problems: Loss of consciousness

  MAUDE report 11669732 ↗
• DeathApr 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT SEVEN MINUTES INTO DIALYSIS TREATMENT, THE PATIENT CODED DUE TO HYPOTENSION. TREATMENT ENDED; HOWEVER, THE PATIENT WAS STILL ATTACHED TO THE TABLO DEVICE AND WAS LEFT IN THE LINES. THE PATIENT'S BLOOD WAS RETURNED AND CARDIOPULMONARY RESUSCITATION (CPR) INITIATED, BUT THE PATIENT EXPIRED. TO NOTE, BEFORE THE TABLO TREATMENT WAS INITIATED, THE PATIENT WAS HYPOTENSIVE. BASED ON THE INFORMATION PROVIDED, THE CLINICAL STAFF DOES NOT BELIEVE THAT THE TABLO DEVICE CAUSED THE EVENT RATHER THIS EVENT WAS ATTRIBUTED TO THE PATIENT'S PRE-EXISTING CONDITIONS.

  Patient problems: Low Blood Pressure/ Hypotension

  MAUDE report 11669718 ↗
• InjuryApr 15, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT WHO WAS COVID-19 POSITIVE CODED DURING A DIALYSIS TREATMENT. IT WAS REPORTED THAT THE PATIENT WAS PREVIOUSLY DIALYZED TWICE DUE TO HIGH POTASSIUM AND CATHETER NOT BEING OPERABLE. DURING THE FIRST TREATMENT SETUP, MACHINE WAS TREATING BUT DUE TO CATHETER ISSUES THE TREATMENT WAS ENDED AND CARE PERSONNEL CONDUCTED A NEW CATHETER PLACEMENT. APPROXIMATELY 44 MINUTES INTO A SECOND TREATMENT SETUP, THE PATIENT SHOWED CONTINUED DECLINE IN BLOOD PRESSURE, THEN PROGRESSED INTO BRADYCARDIA AND ASYSTOLE. CODE BLUE WAS CALLED, BLOOD WAS RETURNED AND PROTOCOLS WERE FOLLOWED, INCLUDING CARDIOPULMONARY RESUSCITATION (CPR) AND MEDICATIONS. TREATMENT WAS NOT RESUMED BECAUSE PATIENT REMAINED TOO UNSTABLE FOR DIALYSIS TREATMENT. BASED ON THE INFORMATION PROVIDED, THE CLINICAL STAFF DOES NOT BELIEVE THAT THE TABLO DEVICE CAUSED THE EVENT RATHER THIS EVENT WAS ATTRIBUTED TO THE PATIENT'S PRE-EXISTING CONDITIONS.

  Patient problems: Loss of consciousness

  MAUDE report 11669708 ↗
• DeathApr 7, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT 2 HOURS AND 30 MINUTES INTO A 4-HOUR DIALYSIS TREATMENT, THE PATIENT LOST CONSCIOUSNESS AND CODED. IT WAS REPORTED THAT THE PATIENT HAD RUN A VENTRICULAR TACHYCARDIA (VTACH) AND THE HEART RATE WAS 170 BPM. THE NURSE ENDED THE TREATMENT AT THIS TIME, A CODE BLUE WAS CALLED AND CARDIOPULMONARY RESUSCITATION(CPR) WAS INITIATED. IT WAS NOTED THAT DUE TO THE PATIENT CODING AND THE NATURE OF THE SITUATION, THE BLOOD WAS NOT RETURNED AND AS A RESULT APPROXIMATELY 240 ML BLOOD WAS LOST. THE FAMILY WAS AT THE BEDSIDE AT THE TIME OF THE EVENT AND DECIDED TO HAVE THE CODE TEAM STOP ALL INTERVENTIONS. THE PATIENT THEN EXPIRED POST-TREATMENT. TO NOTE, BEFORE THE TABLO TREATMENT WAS INITIATED, THE PATIENT WAS HYPOTENSIVE; ALBUMIN WAS GIVEN AND THE BLOOD PRESSURE (BP) IMPROVED. BASED ON THE INFORMATION PROVIDED, THE CLINICAL STAFF DOES NOT BELIEVE THAT THE TABLO DEVICE CAUSED THE EVENT RATHER THIS EVENT WAS ATTRIBUTED TO THE PATIENT'S PRE-EXISTING CONDITIONS.

  Patient problems: Loss of consciousness; Low Blood Pressure/ Hypotension; Tachycardia

  MAUDE report 11628908 ↗
• InjuryApr 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT CODED (CARDIAC ARREST) DURING DIALYSIS TREATMENT. THE CARE PERSONNEL INITIATED CARDIOPULMONARY RESUSCITATION (CPR) AND THE PATIENT WAS REVIVED. PRIOR TO DIALYSIS TREATMENT, THE PATIENT WAS IN CRITICAL CONDITION. PER THE INFORMATION RECEIVED FROM THE CUSTOMER SITE, IT IS NOT BELIEVED THAT THIS EVENT WAS RELATED TO A TABLO DEVICE RATHER, THIS EVENT IS RELATED TO THE PATIENT'S PRE-EXISTING CONDITION.

  Patient problems: Cardiac Arrest

  MAUDE report 11608284 ↗
• InjuryApr 2, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  IT WAS REPORTED THAT A PATIENT CODED (CARDIAC ARREST) DURING A DIALYSIS TREATMENT. THE CARE PERSONNEL INITIATED CARDIOPULMONARY RESUSCITATION (CPR) AND THE PATIENT WAS REVIVED. PRIOR TO DIALYSIS TREATMENT, THE PATIENT WAS IN CRITICAL CONDITION. PER THE INFORMATION RECEIVED FROM THE CUSTOMER SITE, IT IS NOT BELIEVED THAT THIS EVENT WAS RELATED TO A TABLO DEVICE.

  Patient problems: Cardiac Arrest

  MAUDE report 11608258 ↗