NIPRO SET BLOOD TUBING SET WITH TRANSDUCER PROTECTORS AND PRIMING SET A209Y/V803Recalls & reported problems

Summary

The FDA's MAUDE database contains 19 adverse event reports that list this exact device (DI 00383790004053), received between Oct 23, 2019 and Jun 12, 2024 — classified as 9 deaths, 10 malfunctions.

The most frequently reported specific device problem is “Leak/Splash” (6 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 19 most recent of 19 reports, in the reporter's own words as published by the FDA.

• DeathJun 12, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT CODED AT THE END OF 3.5HOUR TREATMENT. PATIENT BECAME UNRESPONSIVE WHILE RETURNING BLOOD, NO PULSE, CHEST COMPRESSIONS WERE STARTED ALONG WITH HIGH FLOW OXYGEN UNTIL PARAMEDICS ARRIVED. CPR WAS STARTED AND STOPPED AFTER 25 MINUTES. DIALYSIS TREATMENT: 3.5HOURS 3 TIMES A WEEK, 1.0K, 2.5 CA, 37 BICARB, 140 NA.

  Patient problems: Loss of consciousness

  MAUDE report 19525369 ↗
• DeathFeb 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT'S BP DROPPED TO 93/49 ABOUT 15 MINS BEFORE END OF TREATMENT. O2 SATURATION DROPPED TO 80% AND MEDICAL EMERGENCY ACTIVATED, 911 CALLED. PATIENT BECAME UNCONSCIOUS WITH NO PULSE. INVESTIGATION ON DIALYSIS PRODUCTS INVOLVED WHEN PATIENT EXPIRED DURING TREATMENT PER FACILITY POLICY. USED BLOOD LINE SAVED BY FACILITY FOR INVESTIGATION. OTHER DEVICES USED: NIPRO SAFE TOUCH TULIP, CODE AND LOT UNKNOWN. DIALYSIS SETTINGS: 3 HRS, 2K2.5CA, BFR 350, DFR 700, 3X/ WEEK TREATMENT.

  Patient problems: Cardiac Arrest; Loss of consciousness; Low Blood Pressure/ Hypotension; Low Oxygen Saturation

  MAUDE report 18794478 ↗
• DeathFeb 27, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  PATIENT'S BP DROPPED TO 93/49 ABOUT 15 MINS BEFORE END OF TREATMENT. O2 SATURATION DROPPED TO 80% AND MEDICAL EMERGENCY ACTIVATED, 911 CALLED. PATIENT BECAME UNCONSCIOUS WITH NO PULSE. INVESTIGATION ON DIALYSIS PRODUCTS INVOLVED WHEN PATIENT EXPIRED DURING TREATMENT PER FACILITY POLICY. USED BLOOD LINE SAVED BY FACILITY FOR INVESTIGATION. OTHER DEVICES USED: NIPRO SAFE TOUCH TULIP, CODE AND LOT UNKNOWN DIALYSIS SETTINGS: 3 HRS, 2K2.5CA, BFR 350, DFR 700, 3X/ WEEK TREATMENT

  Patient problems: Cardiac Arrest; Loss of consciousness; Low Blood Pressure/ Hypotension; Low Oxygen Saturation

  MAUDE report 18794436 ↗
• DeathOct 4, 2022Leak/Splash; Leak/Splash

  PREDIALYSIS, PATIENT WAS STABLE, NO SOB, TALKED TO PCT, FACE EDEMA SEVERE, PERIORBITAL EDEMA SEVERE, AT 10:34 AM BP 94/60 HR 75. HD TX STARTED , PATIENT VOMITING PROJECTILE WITH FLUID, AGONAL BREATHING, LOST CONSCIOUS, PULSE PRESENT, PATIENT WAS TURNED TO LEFT SIDE. HD TX PAUSED, FLUID WAS RINSED BACK TO PATIENT BY PCT, PATIENT WAS PUT ON OXYGEN 5L NC. 911 ACTIVATED, PATIENT STOPPED BREATHING AND PATIENT WAS PUT ON THE FLOOR TO START CPR. PARAMEDIC ARRIVED AND CONTINUED CPR FOR 3 MINS BEFORE ROSC. PATIENT WAS TRANSFERRED TO (B)(6) HOSPITAL. THE NURSING HOME STAFF WAS INFORMED BY MA. CALLED FAMILY, FAMILY DID NOT PICK UP, LEFT MESSAGE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15540119 ↗
• DeathOct 4, 2022Leak/Splash; Leak/Splash

  PREDIALYSIS, PATIENT WAS STABLE, NO SOB, TALKED TO PCT, FACE EDEMA SEVERE, PERIORBITAL EDEMA SEVERE, AT 10:34 AM BP 94/60 HR 75. HD TX STARTED , PATIENT VOMITING PROJECTILE WITH FLUID, AGONAL BREATHING, LOST CONSCIOUS, PULSE PRESENT, PATIENT WAS TURNED TO LEFT SIDE. HD TX PAUSED, FLUID WAS RINSED BACK TO PATIENT BY PCT, PATIENT WAS PUT ON OXYGEN 5L NC. 911 ACTIVATED, PATIENT STOPPED BREATHING AND PATIENT WAS PUT ON THE FLOOR TO START CPR. PARAMEDIC ARRIVED AND CONTINUED CPR FOR 3 MINS BEFORE ROSC. PATIENT WAS TRANSFERRED TO (B)(6) HOSPITAL. THE NURSING HOME STAFF WAS INFORMED BY (B)(6). CALLED FAMILY, FAMILY DID NOT PICK UP, LEFT MESSAGE

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15539660 ↗
• MalfunctionOct 4, 2022Leak/Splash; Leak/Splash

  RN CHECKED MACHINE DUE TO ALARM, NOTED AIR IN THE LINES, CHECKED TO SEE IF CHAMBERS WERE LOW AND THEY WERE NOT, MOVED OVER LINES TO CHECK FOR FAULTS AND BLOOD WAS NOTED COMING OUT OF THE PUMP. LINES WERE CLAMPED AND NO BLOOD WAS RETURNED DUE TO A TEAR IN THE LINES. PATIENT WAS STABLE BP 136/58, PULSE 54. PATIENT WAS TOLD THAT THERE WAS A PROBLEM WITH THE LINES AND THEY NEEDED TO BE CHANGED, PATIENT WAS CLAM. LINES WERE TAKEN OFF THE MACHINE, DOUBLE BAGGED IN BIOHAZARD BAGS WITH ORIGINAL PACKAGING. MACHINE WAS CLEANED AND NEWLINES WERE PRIMED, TREATMENT RESTARTED W/O FURTHER INCIDENT. ESTIMATED 400 CC BLOOD LOSS, MD AWARE, V/S 155/64 PULSE 54, PATIENT ALERT AND ORIENTED W/O COMPLAINTS CLOSELY MONITOR FOR ANY BLOOD INFECTION DRAW CBC ON SAT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15538875 ↗
• MalfunctionOct 4, 2022Leak/Splash; Leak/Splash

  RN CHECKED MACHINE DUE TO ALARM, NOTED AIR IN THE LINES, CHECKED TO SEE IF CHAMBERS WERE LOW AND THEY WERE NOT, MOVED OVER LINES TO CHECK FOR FAULTS AND BLOOD WAS NOTED COMING OUT OF THE PUMP. LINES WERE CLAMPED AND NO BLOOD WAS RETURNED DUE TO A TEAR IN THE LINES. PATIENT WAS STABLE BP 136/58, PULSE 54. PATIENT WAS TOLD THAT THERE WAS A PROBLEM WITH THE LINES AND THEY NEEDED TO BE CHANGED, PATIENT WAS CLAM. LINES WERE TAKEN OFF THE MACHINE, DOUBLE BAGGED IN BIOHAZARD BAGS WITH ORIGINAL PACKAGING. MACHINE WAS CLEANED AND NEWLINES WERE PRIMED, TREATMENT RESTARTED W/O FURTHER INCIDENT. ESTIMATED 400 CC BLOOD LOSS, MD AWARE, V/S 155/64 PULSE 54, PATIENT ALERT AND ORIENTED W/O COMPLAINTS CLOSELY MONITOR FOR ANY BLOOD INFECTION DRAW CBC ON SAT.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15538552 ↗
• MalfunctionJun 27, 2022Obstruction of Flow; Obstruction of Flow

  NURSE MANAGER STATES THAT ON 3 SEPARATE PTS THE VENOUS SIDE OF TUBING CLOTTED RESULTING IN TOTAL BLOOD LOSS. 2 PTS WERE ON MAINTENANCE HEPARIN, 1 NO HEPARIN BUT IS ON ORAL ANTICOAGULANT, AND IS AN ESTABLISHED PATIENT THAT HAS NEVER HAD THIS ISSUE BEFORE ON OTHER LINES, AND SINCE WENT BACK TO PREVIOUS LINES AND W/ NO ISSUES.. REPLACED VOLUME LOST WITH NORMAL SALINE INFUSION, PRIMING PROCESS IS 300ML NS, THEN REFRESH NS AT TREATMENT INITIATION. ADDITIONAL INFO: BFR 350 ON 16 GA NEEDLES, CHEST AVG.

  Patient problems: Insufficient Information

  MAUDE report 14835630 ↗
• MalfunctionJun 27, 2022Obstruction of Flow; Obstruction of Flow

  NURSE MANAGER STATES THAT ON 3 SEPARATE PTS THE VENOUS SIDE OF TUBING CLOTTED RESULTING IN TOTAL BLOOD LOSS. 2 PTS WERE ON MAINTENANCE HEPARIN, 1 NO HEPARIN BUT IS ON ORAL ANTICOAGULANT, AND IS AN ESTABLISHED PATIENT THAT HAS NEVER HAD THIS ISSUE BEFORE ON OTHER LINES, AND SINCE WENT BACK TO PREVIOUS LINES AND W/ NO ISSUES. REPLACED VOLUME LOST WITH NORMAL SALINE INFUSION, PRIMING PROCESS IS 300ML NS, THEN REFRESH NS AT TREATMENT INITIATION. ADDITIONAL INFO: BFR 350 ON 16 GA NEEDLES, CHEST AVG.

  Patient problems: Appropriate Clinical Signs, Symptoms and Conditions Term/Code Not Available

  MAUDE report 14835063 ↗
• DeathFeb 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SECOND INCIDENT WHERE PATIENT EXPIRED DURING DIALYSIS TREATMENT. NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 11346787 ↗
• DeathFeb 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  SECOND INCIDENT WHERE PATIENT EXPIRED DURING DIALYSIS TREATMENT. NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 11346771 ↗
• DeathFeb 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  1ST INCIDENT WHERE PATIENT EXPIRED DURING DIALYSIS TREATMENT. NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 11346753 ↗
• DeathFeb 18, 2021Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  1ST INCIDENT WHERE PATIENT EXPIRED DURING DIALYSIS TREATMENT. NO FURTHER INFORMATION HAS BEEN PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 11346735 ↗
• MalfunctionMay 22, 2020Device Alarm System; Complete Blockage

  3 TOTAL EVENTS OCCURRED, BLOOD LINE CLOTTED ON FRESENIUS 2008K MACHINE. THE PATIENT CARE TECHNICIAN NOTIFIED NOTIFIED THE SENIOR BIOMEDICAL ENGINEER AFTER THE PATIENT WAS DISCONNECTED. THE BLOODLINE WAS STILL ON THE DIALYSIS MACHINE. TECH STATED THERE WAS NO ALARM, THE BLOOD PUMP WAS SPINNING AT 300 ML/MIN AND THE BLOOD WAS NOT MOVING DUE TO THE CLOTTING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 10083632 ↗
• MalfunctionMay 22, 2020Obstruction of Flow; Pumping Problem; Obstruction of Flow; Pumping Problem

  3 TOTAL EVENTS OCCURRED, BLOOD LINE CLOTTED ON FRESENIUS 2008K MACHINE. THE PATIENT CARE TECHNICIAN NOTIFIED NOTIFIED THE SENIOR BIOMEDICAL ENGINEER AFTER THE PATIENT WAS DISCONNECTED. THE BLOODLINE WAS STILL ON THE DIALYSIS MACHINE. TECH STATED THERE WAS NO ALARM, THE BLOOD PUMP WAS SPINNING AT 300 ML/MIN AND THE BLOOD WAS NOT MOVING DUE TO THE CLOTTING.

  Patient problems: Blood Loss

  MAUDE report 10083595 ↗
• MalfunctionFeb 14, 2020Crack; Leak/Splash; Crack; Leak/Splash

  NOTED BLOOD LEAKING ON A PATIENT BLOOD TUBING SET, AT THE BLOOD PUMP AREA, UPON INSPECTING, NOTED A TEAR ON THE BLOOD PUMP SEGMENT OF THE BLOOD TUBING SET AND BLOOD WAS LEAKING, ABOUT 250CC TOTAL BLOOD LOSS. DEVICE LOT NUMBER WAS NOT RECORDED. NOTIFIED BIOMED, HE NOTED THAT THE BLOOD PUMP ROTOR WAS MISSING THE GUIDES FOR THE BLOOD LINES AND MAY OR MAY NOT HAVE CAUSED THE TEAR. BIOMED WAS ABLE TO CHANGE THE MALFUNCTIONED PART, THE TREATMENT WAS RESUMED WITH NEW LINES, THE PATIENT WAS ASYMPTOMATIC, VITAL SIGNS WERE STABLE, AND PATIENT WAS ABLE TO FINISH TREATMENT WITHOUT PROBLEMS, FACILITY ADMINISTRATOR AND PHYSICIAN WAS MADE AWARE OF THE EVENT. THE PATIENT DID RETURN FOR THEIR NEXT SCHEDULED TREATMENT WITHOUT ISSUES.

  Patient problems: Blood Loss

  MAUDE report 9714612 ↗
• MalfunctionFeb 14, 2020Fluid/Blood Leak

  NOTED BLOOD LEAKING ON A PATIENT BLOOD TUBING SET, AT THE BLOOD PUMP AREA, UPON INSPECTING, NOTED A TEAR ON THE BLOOD PUMP SEGMENT OF THE BLOOD TUBING SET AND BLOOD WAS LEAKING, ABOUT 250CC TOTAL BLOOD LOSS. DEVICE LOT NUMBER WAS NOT RECORDED. NOTIFIED BIOMED, HE NOTED THAT THE BLOOD PUMP ROTOR WAS MISSING THE GUIDES FOR THE BLOOD LINES AND MAY OR MAY NOT HAVE CAUSED THE TEAR. BIOMED WAS ABLE TO CHANGE THE MALFUNCTIONED PART, THE TREATMENT WAS RESUMED WITH NEW LINES, THE PATIENT WAS ASYMPTOMATIC,VITAL SIGNS WERE STABLE, AND PATIENT WAS ABLE TO FINISH TREATMENT WITHOUT PROBLEMS, FACILITY ADMINISTRATOR AND PHYSICIAN WAS MADE AWARE OF THE EVENT. THE PATIENT DID RETURN FOR THEIR NEXT SCHEDULED TREATMENT WITHOUT ISSUES.

  Patient problems: Blood Loss

  MAUDE report 9714076 ↗
• MalfunctionOct 23, 2019Leak/Splash; Material Split, Cut or Torn; Leak/Splash; Material Split, Cut or Torn

  0740AM PATIENT CARE TECHNICIAN NOTICED BLOOD LEAK ON THE BLOOD PUMP AREA OF THE MACHINE. PATIENT CARE TECH NOTIFIED THE FACILITY ADMINISTRATOR, UPON INSPECTION NOTED THE TUBING ON THE BLOOD PUMP HAD A TEAR AND WAS LEAKING BLOOD, STAFF RINSED BACK THE ARTERIAL LINE, WAS UNABLE TO RINSE BACK VENOUS LINE DUE TO THE LEAK, PATIENT LOST <150CC OF BLOOD, STAFF EXPLAINED TO THE PATIENT WHAT HAD HAPPENED, AND ADVISED THE PATIENT TO REPORT ANY SIGNS AND SYMPTOMS OF ANEMIA, WILL REDRAW LABS NEXT TREATMENT, NEW BLOOD LINES WERE SET UP, AND TREATMENT WAS RESUMED AT 0747AM. BLOOD PRESSURE WAS WITHIN LIMITS, PATIENT DENIES ANY COMPLAINTS. PHYSICIAN WAS MADE AWARE. LOT NUMBER WAS UNKNOWN.

  Patient problems: Blood Loss; No Clinical Signs, Symptoms or Conditions

  MAUDE report 9226990 ↗
• MalfunctionOct 23, 2019Fluid/Blood Leak; Material Split, Cut or Torn

  0740AM PATIENT CARE TECHNICIAN NOTICED BLOOD LEAK ON THE BLOOD PUMP AREA OF THE MACHINE. PATIENT CARE TECH NOTIFIED THE FACILITY ADMINISTRATOR, UPON INSPECTION NOTED THE TUBING ON THE BLOOD PUMP HAD A TEAR AND WAS LEAKING BLOOD, STAFF RINSED BACK THE ARTERIAL LINE, WAS UNABLE TO RINSE BACK VENOUS LINE DUE TO THE LEAK, PATIENT LOST <150CC OF BLOOD, STAFF EXPLAINED TO THE PATIENT WHAT HAD HAPPENED, AND ADVISED THE PATIENT TO REPORT ANY SIGNS AND SYMPTOMS OF ANEMIA, WILL REDRAW LABS NEXT TREATMENT, NEW BLOOD LINES WERE SET UP, AND TREATMENT WAS RESUMED AT 0747AM. BLOOD PRESSURE WAS WITHIN LIMITS, PATIENT DENIES ANY COMPLAINTS. PHYSICIAN WAS MADE AWARE. LOT NUMBER WAS UNKNOWN.

  Patient problems: Blood Loss

  MAUDE report 9226896 ↗