Nipro Set Blood Tubing Set A430/V912Recalls & reported problems

Summary

The FDA's MAUDE database contains 11 adverse event reports that list this exact device (DI 00383790008808), received between May 23, 2022 and May 11, 2026 — classified as 5 deaths, 2 injuries, 4 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (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, 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.

Most reported problems

Recent adverse event reports

The 11 most recent of 11 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 11, 2026Inadequate Filtration Process

  APPROXIMATELY 30 MINUTES LEFT DURING TREATMENT PATIENT COMPLAINED OF CRAMPING AND NURSE GAVE BOLUS OF SALINE. WHILE THE SOLUTION WAS CLEAR NURSE STATED SHE OBSERVED A CLOT IN THE VENOUS LINE TRAVEL PAST THE CLAMP BOX. STATED SHE CLAMPED THE PATIENT LINE, THE CLOT DID NOT ENTER THE PATIENT. NO FURTHER INTERVENTION NEEDED AFTER CLAMPING THE PATIENT BLUE END OF BLOODLINE. PER FACILITY POLICY THE MACHINE WAS NOT PULLED FROM SERVICE. NO ADDITIONAL INFORMATION PROVIDED. OTHER DEVICES USED: SURDIAL DX HEMODIALYSIS MACHINE, PRODUCT CODE: MC+SDX01, SERIAL#(B)(6). OPTILFLUX DIALYZER: UNKNOW CODE, UNKNOWN LOT#.

  Patient problems: Cramp(s) /Muscle Spasm(s)

  MAUDE report 25145410 ↗
• MalfunctionMay 11, 2026Inadequate Filtration Process

  APPROXIMATELY 30 MINUTES LEFT DURING TREATMENT PATIENT COMPLAINED OF CRAMPING AND NURSE GAVE BOLUS OF SALINE. WHILE THE SOLUTION WAS CLEAR NURSE STATED SHE OBSERVED A CLOT IN THE VENOUS LINE TRAVEL PAST THE CLAMP BOX. STATED SHE CLAMPED THE PATIENT LINE, THE CLOT DID NOT ENTER THE PATIENT. NO FURTHER INTERVENTION NEEDED AFTER CLAMPING THE PATIENT BLUE END OF BLOODLINE. PER FACILITY POLICY THE MACHINE WAS NOT PULLED FROM SERVICE. NO ADDITIONAL INFORMATION PROVIDED. OTHER DEVICES USED: SURDIAL DX HEMODIALYSIS MACHINE, PRODUCT CODE: MC+SDX01, SERIAL# (B)(6). OPTILFLUX DIALYZER: UNKNOW CODE, UNKNOWN LOT#.

  Patient problems: Cramp(s) /Muscle Spasm(s)

  MAUDE report 25145353 ↗
• 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 (B)(6) 2024 DUE TO LOW OXYGEN SATURATION AND GI ISSUES, DISCHARGED FROM THE HOSPITAL (B)(6) 2024. 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

  Patient problems: Anaphylactic Shock; Low Blood Pressure/ Hypotension

  MAUDE report 19889657 ↗
• DeathMay 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  3 HOURS AND 46 MINUTES INTO DIALYSIS TREATMENT PATIENT HAD A CARDIAC EPISODE. FACILITY STATED THAT THEY NOTED THE PATIENT TO HAVE ARRIVED WITH HYPERTENSION PRIOR TO TREATMENT. BLOOD PRESSURE (BP) AT 05:18AM 211/100 HEART RATE (HR) 82, BP AT 05:40AM 220/86 HR 78. TREATMENT INITIATED AT 05:50AM (BP) AT 196/110 (HR) 80. ULTRAFILTRATION (UFR) REDUCED TO 0.1 AT 9:34AM WITH BP 178/97 6 MINUTES PRIOR AND BP 183/89 8 MINUTES POST. MACHINE ALARMED WITH ALL BLOOD PRESSURE READINGS OUT OF PARAMETERS. TREATMENT INTERRUPTED AT 9:43AM, REINFUSION STARTED WITH A TOTAL REINFUSION VOLUME OF 300ML. AT 9:57AM BP 155/147 HR 168, 9:59AM BP 203/167 HR 60, 10:00AM BP 126/82 HR 77, 10:02AM BP 126/28 HR 96. DIALYSATE FLOW RATE (DFR): 700 BLOOD FLOW RATE (BFR): 400, THEN LOWERED TO 375, THEN AGAIN TO 350 DURING TREATMENT UF GOAL 3.5. OTHER DEVICES USED NIPRO SURDIAL DX HEMODIALYSIS SYSTEM, 510K: K182940, SERIAL# (B)(6) NIPRO ELISIO-H DIALYZER, CODE DD+ELISIO-17H, LOT NUMBER UNKNOWN. FACILITY DID NOT RETAIN THE LOT NUMBERS USED FOR THE DIALYZER OR BLOODLINE. ACTUAL SAMPLES WERE DISCARDED BY THE FACILITY. PER FACILITY PATIENT DID NOT HAVE ANY RECENT HOSPITALIZATION AND NO CAUSE OF DEATH WAS PROVIDED. MULTIPLE

  Patient problems: Cardiac Arrest; High Blood Pressure/ Hypertension

  MAUDE report 19337528 ↗
• DeathMay 16, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  3 HOURS AND 46 MINUTES INTO DIALYSIS TREATMENT PATIENT HAD A CARDIAC EPISODE. FACILITY STATED THAT THEY NOTED THE PATIENT TO HAVE ARRIVED WITH HYPERTENSION PRIOR TO TREATMENT. BLOOD PRESSURE (BP) AT 05:18AM 211/100 HEART RATE (HR) 82, BP AT 05:40AM 220/86 HR 78. TREATMENT INITIATED AT 05:50AM (BP) AT 196/110 (HR) 80. ULTRAFILTRATION (UFR) REDUCED TO 0.1 AT 9:34AM WITH BP 178/97 6 MINUTES PRIOR AND BP 183/89 8 MINUTES POST. MACHINE ALARMED WITH ALL BLOOD PRESSURE READINGS OUT OF PARAMETERS. TREATMENT INTERRUPTED AT 9:43AM, REINFUSION STARTED WITH A TOTAL REINFUSION VOLUME OF 300ML. AT 9:57AM BP 155/147 HR 168, 9:59AM BP 203/167 HR 60, 10:00AM BP 126/82 HR 77, 10:02AM BP 126/28 HR 96. DIALYSATE FLOW RATE (DFR): 700. BLOOD FLOW RATE (BFR): 400, THEN LOWERED TO 375, THEN AGAIN TO 350 DURING TREATMENT UF GOAL 3.5. OTHER DEVICES USED : NIPRO SURDIAL DX HEMODIALYSIS SYSTEM, 510K: K182940, SERIAL# (B)(6). NIPRO ELISIO-H DIALYZER, CODE DD+ELISIO-17H, LOT NUMBER UNKNOWN. FACILITY DID NOT RETAIN THE LOT NUMBERS USED FOR THE DIALYZER OR BLOODLINE. ACTUAL SAMPLES WERE DISCARDED BY THE FACILITY. PER FACILITY PATIENT DID NOT HAVE ANY RECENT HOSPITALIZATION AND NO CAUSE OF DEATH WAS PROVIDED. MULT

  Patient problems: Cardiac Arrest; High Blood Pressure/ Hypertension

  MAUDE report 19337445 ↗
• MalfunctionFeb 6, 2024Fluid/Blood Leak; Fluid/Blood Leak

  DURING DIALYSIS TREATMENT, MACHINE ALARMED INSTANTLY FOR BLOOD LEAK WITHIN THE DIALYZER, VISIBLE IN THE ARTERIAL COUPLER TUBING. PATIENT WAS REMOVED FROM THE MACHINE WITHOUT RETURNING THE PATIENT'S BLOOD (APPROXIMATELY 250ML OF BLOOD LOSS) . PER CHARGE NURSE, PATIENT REQUIRED NO FOLLOW UP OR TRANSFUSION POST INCIDENT. DIALYZER USED: F250 DIALYZER MACHINE: SURDIAL DX HEMODIALYSIS SYSTEM PRODUCTG CODE: MC+SDX01 510K: K182940

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18656043 ↗
• InjuryJan 17, 2024Fluid/Blood Leak; Fluid/Blood Leak

  DURING DIALYSIS TREATMENT, MACHINE ALARMED INSTANTLY FOR BLOOD LEAK WITHIN THE DIALYZER, VISIBLE IN THE ARTERIAL COUPLER TUBING. PATIENT WAS REMOVED FROM THE MACHINE WITHOUT RETURNING THE PATIENT'S BLOOD (APPROXIMATELY 250ML OF BLOOD LOSS) . PER CHARGE NURSE, PATIENT REQUIRED NO FOLLOW UP OR TRANSFUSION POST INCIDENT. DIALYZER USED: F250 DIALYZER. MACHINE: SURDIAL DX HEMODIALYSIS SYSTEM. PRODUCTG CODE: MC+SDX01. 510K: K182940.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 18527881 ↗
• MalfunctionNov 16, 2022Loose or Intermittent Connection; Loose or Intermittent Connection

  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 SURDIAL DX HEMODIALYSIS SYSTEM, SERIAL# (B)(4), UDI: (B)(4).

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

  MAUDE report 15811358 ↗
• InjuryNov 16, 2022Loose or Intermittent Connection; Loose or Intermittent Connection

  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 SURDIAL DX HEMODIALYSIS SYSTEM, SERIAL# (B)(4), UDI: (B)(4).

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

  MAUDE report 15810717 ↗
• 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) KG, PATIENT CAME IN @ (B)(6) KG, 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 AVF TULIP 16G NEEDLE - 21J06B, CITRIC ACID - AC-200 - N1H007

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

  MAUDE report 14478033 ↗
• 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 AVF TULIP 16G NEEDLE - 21J06B; CITRIC ACID - AC-200 - N1H007; NIPR

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

  MAUDE report 14477878 ↗