Nipro SURDIAL DX Hemodialysis System MC+SDX01Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI 00383790008815), received between May 23, 2022 and May 29, 2026 — classified as 5 deaths, 2 injuries, 19 malfunctions.

The most frequently reported specific device problem is “Detachment of Device or Device Component” (16 reports).

1 FDA recall record name this device's identifier, 1 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. Oct 27, 2025Class IIOpen, Classified

   Screw may loosen or fallout of Hemodialysis system

   Z-0912-2026 · Root cause: Device Design · Recall details · FDA record ↗

Most reported problems

Recent adverse event reports

The 25 most recent of 26 reports, in the reporter's own words as published by the FDA.

• DeathMay 29, 2026Adverse Event Without Identified Device or Use Problem

  CUSTOMER CONTACTED OUR SERVICING HOTLINE REQUESTING SERVICING FOR 2 MACHINES AND THEN PROCEEDED TO REPORT ANOTHER MACHINE THAT WAS SEQUESTERED DUE TO PATIENT TREATMENT EVENT WHERE THE PATIENT CODED DURING TREATMENT AND WAS HOSPITALIZED, SUBSEQUENTLY REPORTING THE PATIENT PASSED AWAY. CUSTOMER DECLINED TO SHARE ANY ADDITIONAL INFORMATION DUE TO COMPANY POLICY AND PROCEDURES. THE FACILITY ADMINISTRATOR STATED THAT THEY DO NOT BELIEVE OUR MACHINE CAUSED OR CONTRIBUTED TO THE EVENT.

  Patient problems: Cardiac Arrest

  MAUDE report 25340507 ↗
• DeathMay 29, 2026Adverse Event Without Identified Device or Use Problem

  CUSTOMER CONTACTED OUR SERVICING HOTLINE REQUESTING SERVICING FOR 2 MACHINES AND THEN PROCEEDED TO REPORT ANOTHER MACHINE THAT WAS SEQUESTERED DUE TO PATIENT TREATMENT EVENT WHERE THE PATIENT CODED DURING TREATMENT AND WAS HOSPITALIZED, SUBSEQUENTLY REPORTING THE PATIENT PASSED AWAY. CUSTOMER DECLINED TO SHARE ANY ADDITIONAL INFORMATION DUE TO COMPANY POLICY AND PROCEDURES. THE FACILITY ADMINISTRATOR STATED THAT THEY DO NOT BELIEVE OUR MACHINE CAUSED OR CONTRIBUTED TO THE EVENT.

  Patient problems: Cardiac Arrest

  MAUDE report 25340479 ↗
• MalfunctionMay 4, 2026Detachment of Device or Device Component

  THE BIOMED REPORTS BLOOD PUMP HAVING AN AUDIBLE CLICKING SOUND A COUPLE OF WEEKS AGO. THE MACHINE WAS NOT PULLED. JANUARY 31ST MACHINE WAS PULLED DUE TO BLOOD PUMP SCREW FALLING OUT AND THE CLINICIAN FINISHED PATIENTS' TREATMENT. HOWEVER, HAD TO MANUALLY RETURN THE PATIENTS BLOOD. 2/12/26: FIELD SERVICE ENGINEER IDENTIFIED THAT ONE OF THE BOLTS ON THE BLOOD PUMP ROTOR FELL OFF. NEW BLOOD PUMP ROTOR NEEDED TO COMPLETE REPAIR. ROTOR ASSY WAS REPLACED WITH A NEW ONE UNDER THE "BLOOD PUMP ROTOR ASSEMBLY CORRECTIVE ACTION". EXISTING BLOOD PUMP ROTOR REQUIRES REPLACEMENT. EXISTING BPR GAP IS OUTSIDE SPECS. (2.9MM). EXISTING BPR BOLTS AND U-NUTS ARE LOOSE AND OR MISSING. INSTALLED NEW BLOOD PUMP ROTOR ASSEMBLY. PERFORMED BLOOD PUMP OCCLUSION ADJUSTMENT PROCEDURES. VERIFIED TORQUE MOUNTING SCREW AT 2.94 N-M. VERIFIED START UP TEST COMPLETE. PERFORMED A HEAT CITRIC DISINFECTION. THE MACHINE OPERATES PER MANUFACTURER'S SPECIFICATIONS. PERFORMED BLOOD PUMP ROTOR ASSEMBLY ARM COVER VERIFICATION. VERIFIED BLOOD PUMP ROTOR ASSEMBLY ARM COVER, FLAT HEAD SCREWS, AND BPR MOUNTING SCREW WITHIN MANUFACTURE SPECIFICATIONS. CONFIRMED START UP TEST COMPLETE, WITHOUT ANY ERRORS. PERFORMED HEAT CITRIC DIS

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25074300 ↗
• MalfunctionMay 4, 2026Detachment of Device or Device Component

  THE BIOMED REPORTS BLOOD PUMP HAVING AN AUDIBLE CLICKING SOUND A COUPLE OF WEEKS AGO. THE MACHINE WAS NOT PULLED. JANUARY 31ST MACHINE WAS PULLED DUE TO BLOOD PUMP SCREW FALLING OUT AND THE CLINICIAN FINISHED PATIENTS' TREATMENT. HOWEVER, HAD TO MANUALLY RETURN THE PATIENTS BLOOD. 2/12/26 FIELD SERVICE ENGINEER IDENTIFIED THAT ONE OF THE BOLTS ON THE BLOOD PUMP ROTOR FELL OFF. NEW BLOOD PUMP ROTOR NEEDED TO COMPLETE REPAIR. ROTOR ASSY WAS REPLACED WITH A NEW ONE UNDER THE "BLOOD PUMP ROTOR ASSEMBLY CORRECTIVE ACTION". EXISTING BLOOD PUMP ROTOR REQUIRES REPLACEMENT. EXISTING BPR GAP IS OUTSIDE SPECS. (2.9MM). EXISTING BPR BOLTS AND U-NUTS ARE LOOSE AND OR MISSING. INSTALLED NEW BLOOD PUMP ROTOR ASSEMBLY. PERFORMED BLOOD PUMP OCCLUSION ADJUSTMENT PROCEDURES. VERIFIED TORQUE MOUNTING SCREW AT 2.94 N-M. VERIFIED START UP TEST COMPLETE. PERFORMED A HEAT CITRIC DISINFECTION. THE MACHINE OPERATES PER MANUFACTURER'S SPECIFICATIONS. PERFORMED BLOOD PUMP ROTOR ASSEMBLY ARM COVER VERIFICATION. VERIFIED BLOOD PUMP ROTOR ASSEMBLY ARM COVER, FLAT HEAD SCREWS, AND BPR MOUNTING SCREW WITHIN MANUFACTURE SPECIFICATIONS. CONFIRMED START UP TEST COMPLETE, WITHOUT ANY ERRORS. PERFORMED HEAT CITRIC DISI

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25073762 ↗
• MalfunctionMay 4, 2026Detachment of Device or Device Component

  REPORTED CONDITION: CUSTOMER REPORTED THAT SCREW WAS MISSING FROM ROTOR. THE NATIONAL SERVICE AFTER INVESTIGATING, IDENTIFIED THAT 1 OF THE 2 SCREWS HOLDING THE BLOOD PUMP ROTOR FACEPLATE WAS MISSING. ORIGINAL BLOOD PUMP ROTOR GAP AND OCCLUSION PRESSURE ARE WITHIN MANUFACTURE'S SPECIFICATIONS. PERFORMED A VISUAL INSPECTION OF THE BLOOD PUMP MODULE AND ONLY LOCATED THE MISSING FACEPLATE SCREW ON THE BLOOD PUMP ROTOR, NO OTHER ABNORMALITIES IDENTIFIED. INSTALLED THE NEW BLOOD PUMP ROTOR AND PROCEEDED WITH PERFORMING THE BLOOD PUMP OCCLUSION CALIBRATION TO MANUFACTURE SPECIFICATIONS. FOLLOWED UP WITH A SIMULATED TREATMENT TO VERIFY PROPER OPERATION OF THE DEVICE. ADJUSTED THE BLOOD PUMP SPEED DURING TESTING TO ENSURE THE BLOOD PUMP MODULE WAS WORKING TO MANUFACTURE SPECIFICATIONS AND NO ISSUES OR ALARMS IDENTIFIED DURING TESTING. COMPLETED A HEAT CITRIC DISINFECTION AFTER DEVICE VERIFICATION PROCESS. MACHINE HAS BEEN TESTED, VERIFIED, AND DISINFECTED PER IFU. SDX IS OPERATING TO MANUFACTURE SPECIFICATIONS AND RELEASED FOR PATIENT USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25073649 ↗
• MalfunctionApr 27, 2026Detachment of Device or Device Component

  REPORTED CONDITION: CUSTOMER REPORTED THAT A SCREW WAS MISSING FROM BLOOD PUMP ROTOR. AFTER INVESTIGATION, IDENTIFIED THAT THE SCREWS HOLDING THE FACE PLATE TO THE BLOOD PUMP ROTOR WERE MISSING. PERFORMED A VISUAL INSPECTION OF THE BLOOD PUMP MODULE AND VERIFIED THAT THE FACEPLATE SCREWS WERE IN FACT MISSING ON THE BLOOD PUMP ROTOR, NO OTHER ABNORMALITIES IDENTIFIED. INSTALLED THE NEW BLOOD PUMP ROTOR AND PROCEEDED WITH PERFORMING THE BLOOD PUMP OCCLUSION CALIBRATION TO MANUFACTURE SPECIFICATIONS. FOLLOWED UP WITH A SIMULATED TREATMENT TO VERIFY PROPER OPERATION OF THE DEVICE. ADJUSTED THE BLOOD PUMP SPEED DURING TESTING TO ENSURE THE BLOOD PUMP MODULE WAS WORKING TO MANUFACTURE SPECIFICATIONS AND NO ISSUES OR ALARMS IDENTIFIED DURING TESTING. COMPLETED A HEAT CITRIC DISINFECTION AFTER DEVICE VERIFICATION PROCESS. MACHINE HAS BEEN TESTED, VERIFIED, AND DISINFECTED PER IFU. SDX IS OPERATING TO MANUFACTURE SPECIFICATIONS AND RELEASED FOR PATIENT USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25001132 ↗
• MalfunctionApr 27, 2026Detachment of Device or Device Component

  REPORTED CONDITION: CUSTOMER REPORTED THAT A SCREW WAS MISSING FROM BLOOD PUMP ROTOR. AFTER INVESTIGATION, IDENTIFIED THAT THE SCREWS HOLDING THE FACE PLATE TO THE BLOOD PUMP ROTOR WERE MISSING. PERFORMED A VISUAL INSPECTION OF THE BLOOD PUMP MODULE AND VERIFIED THAT THE FACEPLATE SCREWS WERE IN FACT MISSING ON THE BLOOD PUMP ROTOR, NO OTHER ABNORMALITIES IDENTIFIED. INSTALLED THE NEW BLOOD PUMP ROTOR AND PROCEEDED WITH PERFORMING THE BLOOD PUMP OCCLUSION CALIBRATION TO MANUFACTURE SPECIFICATIONS. FOLLOWED UP WITH A SIMULATED TREATMENT TO VERIFY PROPER OPERATION OF THE DEVICE. ADJUSTED THE BLOOD PUMP SPEED DURING TESTING TO ENSURE THE BLOOD PUMP MODULE WAS WORKING TO MANUFACTURE SPECIFICATIONS AND NO ISSUES OR ALARMS IDENTIFIED DURING TESTING. COMPLETED A HEAT CITRIC DISINFECTION AFTER DEVICE VERIFICATION PROCESS. MACHINE HAS BEEN TESTED, VERIFIED, AND DISINFECTED PER IFU. SDX IS OPERATING TO MANUFACTURE SPECIFICATIONS AND RELEASED FOR PATIENT USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25001131 ↗
• MalfunctionApr 27, 2026Detachment of Device or Device Component

  REPORTED CONDITION: LOOSE SCREW ON BLOOD PUMP ROTORS ON BOTH MACHINES REPORTED BY STAFF (B)(6): EXISTING BLOOD PUMP ROTOR REQUIRES REPLACEMENT. SCREWS ON FACE PLATE ARE LOOSE. INSTALLED NEW BLOOD PUMP ROTOR ASSEMBLY AND PERFORMED BLOOD PUMP OCCLUSION ADJUSTMENT PROCEDURES. THE MACHINE OPERATES PER THE MANUFACTURER SPECIFICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25001037 ↗
• MalfunctionApr 27, 2026Detachment of Device or Device Component

  REPORTED CONDITION: LOOSE SCREW ON BLOOD PUMP ROTORS ON BOTH MACHINES REPORTED BY STAFF ON B)(6): EXISTING BLOOD PUMP ROTOR REQUIRES REPLACEMENT. SCREWS ON FACE PLATE ARE LOOSE. INSTALLED NEW BLOOD PUMP ROTOR ASSEMBLY AND PERFORMED BLOOD PUMP OCCLUSION ADJUSTMENT PROCEDURES. THE MACHINE OPERATES PER THE MANUFACTURER SPECIFICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25001032 ↗
• MalfunctionApr 27, 2026Detachment of Device or Device Component

  REPORTED CONDITION: LOOSE SCREW ON BLOOD PUMP ROTORS ON BOTH MACHINES REPORTED BY STAFF. (B)(6): EXISTING BLOOD PUMP ROTOR REQUIRES REPLACEMENT. SCREWS ON FACE PLATE ARE LOOSE. INSTALLED NEW BLOOD PUMP ROTOR ASSEMBLY AND PERFORMED BLOOD PUMP OCCLUSION ADJUSTMENT PROCEDURES. THE MACHINE OPERATES PER THE MANUFACTURER SPECIFICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25001031 ↗
• MalfunctionApr 27, 2026Detachment of Device or Device Component

  REPORTED CONDITION: LOOSE SCREW ON BLOOD PUMP ROTORS ON BOTH MACHINES REPORTED BY STAFF. (B)(6): EXISTING BLOOD PUMP ROTOR REQUIRES REPLACEMENT. SCREWS ON FACE PLATE ARE LOOSE. INSTALLED NEW BLOOD PUMP ROTOR ASSEMBLY AND PERFORMED BLOOD PUMP OCCLUSION ADJUSTMENT PROCEDURES. THE MACHINE OPERATES PER THE MANUFACTURER SPECIFICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25001030 ↗
• MalfunctionApr 27, 2026Detachment of Device or Device Component

  REPORTED CONDITION: CUSTOMER REPORTED LOOSE SCREW ON BLOOD PUMP ROTOR. THE NATIONAL SERVICE AFTER INVESTIGATING, IDENTIFIED THAT BOLTS AND U NUTS WERE MISSING FROM ROTOR AND GAP TEST OUT OF SPECIFICATIONS. INSTALLED NEW BLOOD PUMP ROTOR ASSEMBLY, AND PERFORMED BLOOD PUMP OCCLUSION ADJUSTMENT PROCEDURES. THE MACHINE OPERATES PER THE MANUFACTURER'S SPECIFICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25000504 ↗
• MalfunctionApr 27, 2026Detachment of Device or Device Component

  REPORTED CONDITION: CUSTOMER REPORTED LOOSE SCREW ON BLOOD PUMP ROTOR. THE NATIONAL SERVICE AFTER INVESTIGATING, IDENTIFIED THAT BOLTS AND U NUTS WERE MISSING FROM ROTOR AND GAP TEST OUT OF SPECIFICATIONS. INSTALLED NEW BLOOD PUMP ROTOR ASSEMBLY, AND PERFORMED BLOOD PUMP OCCLUSION ADJUSTMENT PROCEDURES. THE MACHINE OPERATES PER THE MANUFACTURER'S SPECIFICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 25000502 ↗
• MalfunctionApr 27, 2026Noise, Audible

  REPORTED CONDITION: CUSTOMER REPORTED A CLICKING NOISE COMING FROM BLOOD PUMP AREA DURING PATIENT TREATMENT. 10/24/25 NATIONAL SERVICE ENGINEER INVESTIGATED AND WAS ABLE TO DUPLICATE THE SOUND IN RECIRCULATION WITH 18G NEEDLE AND BLOOD PUMP SPEED AT 400 ML/MIN. DID NOT PRODUCE NOISE WITHOUT THE NEEDLE RESTRICTION. MACHINE STATE AS FOUND: PUSH PIN DEPTH AT .62 MM, OCCLUSION TEST SURPASSED 14.2 PSI IN 10 ROTATIONS AND ROLLER GAP PASSED 2.9 MM TEST. CLEANED BLOOD PUMP ROTOR HOUSING, ENSURED BLOOD PUMP MOTOR SCREWS WERE TIGHTENED TO SPECIFICATION. REPLACED BLOOD PUMP ROTOR NOISE PERSISTS. FURTHER INVESTIGATION REQUIRED. NOT CLEARED FOR PATIENT USE. 10/30/25 NATIONAL SERVICE ENGINEER DUPLICATED NOISE AFTER MORE THAN AN HOUR OF RUNNING THE BLOOD PUMP AT 450 ML/MIN. PREVIOUS REPLACEMENT OF THE BLOOD PUMP ROTOR DEMONSTRATED NO CHANGE IN SYMPTOM. REPLACED ENTIRE TUBING PUMP ASSEMBLY. POST-REPLACEMENT CALIBRATIONS WERE: ROLLER GAP AT 2.9 MM; OCCLUSION TEST SURPASSED 14.2 PSI IN LESS THAN 5 REVOLUTIONS; PUSH PIN GAP WAS .71 MM. AFTER RUNNING FOR AN HOUR AT 450 ML/MIN, SOUND WAS NO LONGER PRESENT. PASSED ALL TESTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24999703 ↗
• MalfunctionApr 27, 2026Noise, Audible

  REPORTED CONDITION: CUSTOMER REPORTED A CLICKING NOISE COMING FROM BLOOD PUMP AREA DURING PATIENT TREATMENT. (B)(6) 2025 NATIONAL SERVICE ENGINEER INVESTIGATED AND WAS ABLE TO DUPLICATE THE SOUND IN RECIRCULATION WITH 18G NEEDLE AND BLOOD PUMP SPEED AT 400 ML/MIN. DID NOT PRODUCE NOISE WITHOUT THE NEEDLE RESTRICTION. MACHINE STATE AS FOUND: PUSH PIN DEPTH AT .62 MM, OCCLUSION TEST SURPASSED 14.2 PSI IN 10 ROTATIONS AND ROLLER GAP PASSED 2.9 MM TEST. CLEANED BLOOD PUMP ROTOR HOUSING, ENSURED BLOOD PUMP MOTOR SCREWS WERE TIGHTENED TO SPECIFICATION. REPLACED BLOOD PUMP ROTOR.NOISE PERSISTS. FURTHER INVESTIGATION REQUIRED. NOT CLEARED FOR PATIENT USE. (B)(6) 2025 NATIONAL SERVICE ENGINEER DUPLICATED NOISE AFTER MORE THAN AN HOUR OF RUNNING THE BLOOD PUMP AT 450 ML/MIN. PREVIOUS REPLACEMENT OF THE BLOOD PUMP ROTOR DEMONSTRATED NO CHANGE IN SYMPTOM. REPLACED ENTIRE TUBING PUMP ASSEMBLY. POST-REPLACEMENT CALIBRATIONS WERE: ROLLER GAP AT 2.9 MM; OCCLUSION TEST SURPASSED 14.2 PSI IN LESS THAN 5 REVOLUTIONS; PUSH PIN GAP WAS .71 MM. AFTER RUNNING FOR AN HOUR AT 450 ML/MIN, SOUND WAS NO LONGER PRESENT. PASSED ALL TESTS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24999420 ↗
• MalfunctionApr 24, 2026Detachment of Device or Device Component

  REPORTED CONDITION: CUSTOMER REPORTED THAT SCREW WAS MISSING FROM ROTOR. THE NATIONAL SERVICE AFTER INVESTIGATING, IDENTIFIED THAT 1 OF THE 2 SCREWS HOLDING THE BLOOD PUMP ROTOR FACEPLATE WAS MISSING. ORIGINAL BLOOD PUMP ROTOR GAP AND OCCLUSION PRESSURE ARE WITHIN MANUFACTURE'S SPECIFICATIONS. PERFORMED A VISUAL INSPECTION OF THE BLOOD PUMP MODULE AND ONLY LOCATED THE MISSING FACEPLATE SCREW ON THE BLOOD PUMP ROTOR, NO OTHER ABNORMALITIES IDENTIFIED. INSTALLED THE NEW BLOOD PUMP ROTOR AND PROCEEDED WITH PERFORMING THE BLOOD PUMP OCCLUSION CALIBRATION TO MANUFACTURE SPECIFICATIONS. FOLLOWED UP WITH A SIMULATED TREATMENT TO VERIFY PROPER OPERATION OF THE DEVICE. ADJUSTED THE BLOOD PUMP SPEED DURING TESTING TO ENSURE THE BLOOD PUMP MODULE WAS WORKING TO MANUFACTURE SPECIFICATIONS AND NO ISSUES OR ALARMS IDENTIFIED DURING TESTING. COMPLETED A HEAT CITRIC DISINFECTION AFTER DEVICE VERIFICATION PROCESS. MACHINE HAS BEEN TESTED, VERIFIED, AND DISINFECTED PER IFU. SDX IS OPERATING TO MANUFACTURE SPECIFICATIONS AND RELEASED FOR PATIENT USE.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24990340 ↗
• MalfunctionApr 24, 2026Detachment of Device or Device Component

  REPORTED CONDITION: E74, E75 AND E132. MACHINE NOT EJECTING BLOOD LINES CARTRIDGE FROM BLOOD PUMP ROTOR. NOISE DURING EJECTION. THE NATIONAL SERVICE ENGINEER TESTED THE BLOOD PUMP ROTOR AND IT FAILED BLOOD PUMP OCCLUSION TEST FOR BEING TOO TIGHT. ROTOR ASSEMBLY COMPLETE WITHOUT ANY NOISE UNDER NORMAL OPERATION UNTIL ATTEMPTED EJECTION. REPLACED BLOOD PUMP ROTOR ASSEMBLY. SET PROPER BLOOD OCCLUSION WITH FEELER GAUGE AND PASSED BLOOD PUMP ROTOR PRESSURE WITHIN 5 REVOLUTIONS. PUSH PIN DEPTH AT .72 MM. PASSED ALL TESTS AFTER REPLACEMENT. MACHINE IS OPERATING PER MANUFACTURERS SPECIFICA.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24990195 ↗
• MalfunctionApr 24, 2026Detachment of Device or Device Component

  REPORTED CONDITION: E74, E75 AND E132. MACHINE NOT EJECTING BLOOD LINES CARTRIDGE FROM BLOOD PUMP ROTOR. NOISE DURING EJECTION. THE NATIONAL SERVICE ENGINEER TESTED THE BLOOD PUMP ROTOR AND IT FAILED BLOOD PUMP OCCLUSION TEST FOR BEING TOO TIGHT. ROTOR ASSEMBLY COMPLETE WITHOUT ANY NOISE UNDER NORMAL OPERATION UNTIL ATTEMPTED EJECTION. REPLACED BLOOD PUMP ROTOR ASSEMBLY. SET PROPER BLOOD OCCLUSION WITH FEELER GAUGE AND PASSED BLOOD PUMP ROTOR PRESSURE WITHIN 5 REVOLUTIONS. PUSH PIN DEPTH AT .72 MM. PASSED ALL TESTS AFTER REPLACEMENT. MACHINE IS OPERATING PER MANUFACTURERS SPECIFICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 24990021 ↗
• MalfunctionOct 29, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  REPORTED CONDITION: FRONT ROTOR PANEL FLAT HEAD SCREW IS MISSING. THE NATIONAL SERVICE ENGINEER INSTALLED NEW BLOOD PUMP ROTOR ASSEMBLY SERIAL# (B)(6) AND PERFORM BLOOD PUMP OCCLUSION AND ADJUSTMENT PROCEDURE. MACHINE OPERATES PER MANUFACTURER SPECIFICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23411278 ↗
• MalfunctionOct 28, 2025Detachment of Device or Device Component; Detachment of Device or Device Component

  REPORTED CONDITION: FRONT ROTOR PANEL FLAT HEAD SCREW IS MISSING. THE NATIONAL SERVICE ENGINEER INSTALLED NEW BLOOD PUMP ROTOR ASSEMBLY SERIAL#: (B)(6) AND PERFORM BLOOD PUMP OCCLUSION AND ADJUSTMENT PROCEDURE. MACHINE OPERATES PER MANUFACTURER SPECIFICATIONS.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 23410587 ↗
• DeathAug 1, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT WAS ADMITTED TO THE HOSPITAL ON 06/21/2024 DUE TO LOW OXYGEN SATURATION AND GI ISSUES, DISCHARGED FROM THE HOSPITAL 07/02/202024. IT WAS HER FIRST TREATMENT IN THE CLINIC POST HOSPITALIZATION. TREATMENT STARTED 7:07AM WITH A BLOOD PRESSURE (BP) OF 110/49 AND IT STARTED DROPPING. 7:30 - BP 93/43 MM/HG: 8:00 - BP 95/52 MM/HG AND 9 AM - BP WAS 99/38 MM/HG AND THEY STOPPED THE ULTRAFILTRATION (UF). PATIENT STARTED VOMITING AND PASSED OUT, CPR WAS PERFORMED, FLUIDS WERE GIVEN AND PARAMEDICS WERE CALLED. THEY TRIED ENDING THE TREATMENT BUT WERE UNABLE TO UNTIL AFTER PATIENT WAS PRONOUNCED DEAD @ 10:24 AM. DIALYZER/BLOODLINES WERE SAVED. STAFF STATED THAT THERE WERE NO ALARMS TRIGGERED BEFORE OR DURING THE EVENT, EXCEPT FOR TREATMENT RELATED ALARMS PRIOR TO EVENT. CAUSE OF DEATH IS STILL UNKNOWN. THERE WERE NO ISSUES REPORTED WITH ANY OF THE NIPRO DEVICES USED. TREATMENT TIME - 3.5 HRS; BLOOD FLOW RATE (BFR) - 250; DIALYSATE FLOW RATE (DFR) - 600; A/B - 3K, 2.5; BICARB - 35, TEMP - 35.5; NA - 138; ACCESS: CVC; UF GOAL - 4L; UF REMOVED - 1.5 L; ESTIMATED DRY WEIGHT (EDW) - 74 KG; PRE WEIGHT - 77.5 KG MEDICATIONS GIVEN; MIRCERA - 60 MCG; VENOFER - 50 MG COMORBIDS: CANCER, CHRONIC OB

  Patient problems: Anaphylactic Shock; Low Blood Pressure/ Hypotension

  MAUDE report 19889324 ↗
• MalfunctionNov 16, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  APPROXIMATELY 2 HOURS INTO DIALYSIS TREATMENT A PATIENT HAD SIGNIFICANT BLOOD LOSS FROM VENOUS NEEDLE CONNECTION. FACILITY ADMINISTRATOR STATED THE CONNECTION WAS LOOSE. THEY PLACED TOWELS ON THE FLOOR SURROUNDING THE BLOOD AND ESTIMATED 2-24 INCHES OF BLOOD. VITALS TAKEN AT 11:30AM WERE STABLE AND ACCESS WAS VISUALIZED. AT ABOUT 11:45AM, PATIENT SEEMED CONFUSED AND BLOOD PRESSURE WAS 70/38. THE TEAM WAS ABLE TO SECURE THE LINE AND RETURN THE PATIENT'S BLOOD. PATIENT WAS THEN SENT TO THE HOSPITAL FOR BLOOD TRANSFUSION AND OBSERVATION, SUBSEQUENTLY REQUIRING 2ND BLOOD TRANSFUSION. PATIENT RETURNED TO REGULAR DIALYSIS TREATMENT ON (B)(6) 2022 WITHOUT COMPLICATIONS. OTHER DEVICES USED: NIPRO BLOOD TUBING SET W/TP. PRODUCT CODE: (B)(4). LOT#: 21A11.

  Patient problems: Confusion/ Disorientation; Low Blood Pressure/ Hypotension

  MAUDE report 15811610 ↗
• DeathMay 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT 10: 54 AM, WITH 34 MINUTES INTO A 2.5 HRS TREATMENT, PATIENT SAID HE NEEDS TO USE THE RESTROOM DUE TO BOWEL MOVEMENT AND WAS RESTLESS, BP WAS 84/42 MMHG, P=67. STAFF PUT PATIENT ON T POSITION AND STAFF NOTICED AFTER THAT PATIENT HAD A BLANK STARE AND WAS UNRESPONSIVE. NURSE WAS CALLED, BLOOD WAS RETURNED, AND TREATMENT WAS ENDED. NURSE DID A CHEST RUB, GAVE OXYGEN AND 911 WAS CALLED. AT 11:03 AM BLOOD SUGAR WAS 113MG/DL. 11:06 AM - BP WAS 127/66, P 119, BUT RESPIRATORY RATE WAS ONLY 2 AND NURSE WAS GIVING OXYGEN THROUGH AMBU BAG. PARAMEDICS CAME AND PRONOUNCED THE PATIENT DECEASED AT 11:17 AM. FAMILY WAS CONTACTED AND DECIDED NOT TO SEND PATIENT TO THE HOSPITAL. PATIENT HAD PREVIOUSLY SIGNED A DNR ON (B)(6) 2022. PATIENT HAS A HISTORY OF NON-COMPLIANCE, MISSING AND NOT COMPLETING TREATMENTS. PATIENT TREATMENT ORDERS/INFORMATION: TX TIME - 2.5 HRS; BFR - 300; DFR - 500; EDW - (B)(6). PATIENT CAME IN @ (B)(6), GOAL SET AT 600 ML. BP AT START OF TREATMENT - 90/51 MMHG, P= 66. ONLY HEPARIN 2000 UNITS WAS GIVEN. NO NEW MEDICATIONS STARTED. OTHER PRODUCTS USED DURING THE EVENT: NIPRO ELISIO-15H DIALYZER - 21J14F; NIPRO BLOOD TUBGIN SET - 20F15; NIPRO AVF TULIP NEEDLE - 21J06B; CITRIC

  Patient problems: Decreased Respiratory Rate; Loss of consciousness; Low Oxygen Saturation

  MAUDE report 14478683 ↗
• DeathMay 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  AT 10: 54 AM, WITH 34 MINUTES INTO A 2.5 HRS TREATMENT, PATIENT SAID HE NEEDS TO USE THE RESTROOM DUE TO BOWEL MOVEMENT AND WAS RESTLESS, BP WAS 84/42 MMHG, P=67. STAFF PUT PATIENT ON T POSITION AND STAFF NOTICED AFTER THAT PATIENT HAD A BLANK STARE AND WAS UNRESPONSIVE. NURSE WAS CALLED, BLOOD WAS RETURNED, AND TREATMENT WAS ENDED. NURSE DID A CHEST RUB, GAVE OXYGEN AND 911 WAS CALLED. AT 11:03 AM BLOOD SUGAR WAS 113MG/DL. 11:06 AM - BP WAS 127/66, P 119, BUT RESPIRATORY RATE WAS ONLY 2 AND NURSE WAS GIVING OXYGEN THROUGH AMBU BAG. PARAMEDICS CAME AND PRONOUNCED THE PATIENT DECEASED AT 11:17 AM. FAMILY WAS CONTACTED AND DECIDED NOT TO SEND PATIENT TO THE HOSPITAL. PATIENT HAD PREVIOUSLY SIGNED A DNR ON (B)(6) 2022. PATIENT HAS A HISTORY OF NON-COMPLIANCE, MISSING AND NOT COMPLETING TREATMENTS. PATIENT TREATMENT ORDERS/INFORMATION: TX TIME - 2.5 HRS; BFR - 300; DFR - 500; EDW - (B)(6). PATIENT CAME IN @ (B)(6), GOAL SET AT 600 ML. BP AT START OF TREATMENT - 90/51 MMHG, P= 66. ONLY HEPARIN 2000 UNITS WAS GIVEN. NO NEW MEDICATIONS STARTED. OTHER PRODUCTS USED DURING THE EVENT: NIPRO ELISIO-15H DIALYZER - 21J14F; NIPRO BLOOD TUBGIN SET - 20F15; NIPRO AVF TULIP NEEDLE - 21J06B; CITRIC

  Patient problems: Decreased Respiratory Rate; Loss of consciousness; Low Oxygen Saturation

  MAUDE report 14478197 ↗
• InjuryMay 23, 2022Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  58 MINUTES INTO A TWO-HOUR DIALYSIS TREATMENT THE AFFECTED PATIENT STARTED VOMITING AND SUBSEQUENTLY HAD A WITNESSED GRAND-MAL SEIZURE. THIS LASTED 1-2 MINUTES AND THEN SUBSIDED. THE TREATMENT WAS ENDED WITH A TOTAL OF 489 ML UF(ULTRAFILTRATION). EMS WAS DISPATCHED AND BY THE TIME THEY ARRIVED IN THE FACILITY THE PATIENT WAS FULLY CONSCIOUS AND RECOVERED FROM THE EVENT. THE NURSE NOTED THAT THERE WAS NO CHANGE IN VITAL SIGNS BEFORE THE EVENT, AND NO INDICATION TO HER THAT THERE WAS AN IMPENDING EVENT. THIS PATIENT IS AN ESTABLISHED DIALYSIS PATIENT WITH NO HISTORY OF SEIZURES. PER THE NURSE, AFTER THE EVENT THE PATIENTS BLOOD PRESSURE WAS SLIGHTLY ELEVATED, BUT WITHIN NORMAL RANGE. THE PATIENT WAS TAKEN TO THE HOSPITAL AND CLEARED TO RETURN BACK TO THE NURSING HOME THAT SAME DAY. THE PATIENT RECEIVED DIALYSIS TREATMENTS WEDNESDAY (B)(6) 2022, THURSDAY (B)(6) 2022 AND FRIDAY (B)(6) 2022 WITH NO ADVERSE EVENTS. (B)(6) 2022: RN SAID PATIENT DIALYZED WITH NO ISSUES. PATIENT HAD HISTORY OF STROKE BUT NO HISTORY OF SEIZURES. PER NURSE, NO MEDICATIONS WERE GIVEN DURING THE TREATMENT WHEN THE EVENT HAPPENED, AND NO NEW MEDICATION WAS STARTED. PATIENT HAS CVC BUT HAD AVF SURGERY (B)(6) 2022

  Patient problems: Convulsion/Seizure; High Blood Pressure/ Hypertension

  MAUDE report 14470001 ↗