NIPRO SET BLOOD TUBING SET WITH TRANSDUCER PROTECTORS AND PRIMING SET A223D/V809DRecalls & reported problems

Summary

The FDA's MAUDE database contains 9 adverse event reports that list this exact device (DI 00383790004176), received between May 9, 2018 and May 13, 2026 — classified as 2 injuries, 7 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (4 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 9 most recent of 9 reports, in the reporter's own words as published by the FDA.

• MalfunctionMay 13, 2026Fluid/Blood Leak

  THE CUSTOMER ADVISED THAT THE MACHINES ARE DETECTING CONTINUOUS AIR & BLOOD GOING INTO THE TRANSDUCER. NO ONE WAS INJURED. THE ISSUE OCCURRED DURING THE 1ST AND 2ND SHIFTS ONLY. AFTER REMOVING THE REPORTED LOT NUMBER, NO FURTHER ISSUES WERE NOTED. THE CLINIC EXPERIENCED CLOTTED SYSTEMS AND HAD TO RESTRING THE MACHINES USING BLOODLINES FROM A DIFFERENT LOT NUMBER. ALL PATIENTS WERE ABLE TO COMPLETE THEIR TREATMENTS WITHOUT FURTHER COMPLICATIONS. SOME PATIENTS DID LOSE BLOOD; HOWEVER, THEY ARE UNABLE TO CONFIRM HOW MANY PATIENTS WERE AFFECTED OR THE AMOUNT OF BLOOD LOST. THEY ALSO CANNOT CONFIRM WHETHER HGB WAS CHECKED FOR ALL PATIENTS.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 25164933 ↗
• MalfunctionMay 13, 2026Fluid/Blood Leak

  THE CUSTOMER ADVISED THAT THE MACHINES ARE DETECTING CONTINUOUS AIR & BLOOD GOING INTO THE TRANSDUCER. NO ONE WAS INJURED. THE ISSUE OCCURRED DURING THE 1ST AND 2ND SHIFTS ONLY. AFTER REMOVING THE REPORTED LOT NUMBER, NO FURTHER ISSUES WERE NOTED. THE CLINIC EXPERIENCED CLOTTED SYSTEMS AND HAD TO RESTRING THE MACHINES USING BLOODLINES FROM A DIFFERENT LOT NUMBER. ALL PATIENTS WERE ABLE TO COMPLETE THEIR TREATMENTS WITHOUT FURTHER COMPLICATIONS. SOME PATIENTS DID LOSE BLOOD; HOWEVER, THEY ARE UNABLE TO CONFIRM HOW MANY PATIENTS WERE AFFECTED OR THE AMOUNT OF BLOOD LOST. THEY ALSO CANNOT CONFIRM WHETHER HGB WAS CHECKED FOR ALL PATIENTS.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 25164220 ↗
• MalfunctionJan 13, 2023Material Puncture/Hole; Material Puncture/Hole

  DURING THE 1ST MINUTE OF TREATMENT, A PHYSICAL LEAK WAS NOTED ON THE BLOOD PUMP, TREATMENT STOPPED, BLOOD WAS NOT RETURNED. NEW SET UP DONE USING SAME LOT #, DIFFERENT MACHINE AND FINISHED TREATMENT WITH NO ISSUES. PATIENT LOST 200ML OF BLOOD. NO HOSPITALIZATION. HBG RECHECKED, NO DATA ON BASELINE HGB AND NO RESULT YET. IV ANTIBIOTICS STARTED AS A PROPHYLAXIS. THE BIOMED ALSO CHECKED THE MACHINE AND ORDERED SOME PARTS OF THE BLOOD PUMP SEGMENT. THE MANAGER ALSO MENTIONED THAT THEY JUST HAD A RECALL OF SOME OF THE MACHINES BECAUSE OF ISSUES WITH THE BLOOD PUMP SEGMENT. OTHER DEVICES USED: FRESENIUS 2008T.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16164989 ↗
• MalfunctionJan 13, 2023Material Puncture/Hole; Material Puncture/Hole

  DURING THE 1ST MINUTE OF TREATMENT, A PHYSICAL LEAK WAS NOTED ON THE BLOOD PUMP, TREATMENT STOPPED, BLOOD WAS NOT RETURNED. NEW SET UP DONE USING SAME LOT #, DIFFERENT MACHINE AND FINISHED TREATMENT WITH NO ISSUES. PATIENT LOST 200ML OF BLOOD. NO HOSPITALIZATION. HBG RECHECKED, NO DATA ON BASELINE HGB AND NO RESULT YET. IV ANTIBIOTICS STARTED AS A PROPHYLAXIS. THE BIOMED ALSO CHECKED THE MACHINE AND ORDERED SOME PARTS OF THE BLOOD PUMP SEGMENT. THE MANAGER ALSO MENTIONED THAT THEY JUST HAD A RECALL OF SOME OF THE MACHINES BECAUSE OF ISSUES WITH THE BLOOD PUMP SEGMENT. OTHER DEVICES USED: FRESENIUS 2008T.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16164902 ↗
• MalfunctionJan 13, 2023Material Puncture/Hole; Material Puncture/Hole

  DURING THE 1ST MINUTE OF TREATMENT, A PHYSICAL LEAK WAS NOTED ON THE BLOOD PUMP, TREATMENT STOPPED, BLOOD WAS NOT RETURNED. NEW SET UP DONE USING SAME LOT #, DIFFERENT MACHINE AND FINISHED TREATMENT WITH NO ISSUES. PATIENT LOST 200ML OF BLOOD. NO HOSPITALIZATION. HBG RECHECKED, NO DATA ON BASELINE HGB AND NO RESULT YET. IV ANTIBIOTICS STARTED AS A PROPHYLAXIS. THE BIOMED ALSO CHECKED THE MACHINE AND ORDERED SOME PARTS OF THE BLOOD PUMP SEGMENT. THE MANAGER ALSO MENTIONED THAT THEY JUST HAD A RECALL OF SOME OF THE MACHINES BECAUSE OF ISSUES WITH THE BLOOD PUMP SEGMENT. OTHER DEVICES USED: FRESENIUS 2008T.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16164893 ↗
• MalfunctionJan 13, 2023Material Puncture/Hole; Material Puncture/Hole

  DURING THE 1ST MINUTE OF TREATMENT, A PHYSICAL LEAK WAS NOTED ON THE BLOOD PUMP, TREATMENT STOPPED, BLOOD WAS NOT RETURNED. NEW SET UP DONE USING SAME LOT #, DIFFERENT MACHINE AND FINISHED TREATMENT WITH NO ISSUES. PATIENT LOST 200ML OF BLOOD. NO HOSPITALIZATION. HBG RECHECKED, NO DATA ON BASELINE HGB AND NO RESULT YET. IV ANTIBIOTICS STARTED AS A PROPHYLAXIS. THE BIOMED ALSO CHECKED THE MACHINE AND ORDERED SOME PARTS OF THE BLOOD PUMP SEGMENT. THE MANAGER ALSO MENTIONED THAT THEY JUST HAD A RECALL OF SOME OF THE MACHINES BECAUSE OF ISSUES WITH THE BLOOD PUMP SEGMENT. OTHER DEVICES USED: FRESENIUS 2008T.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16164561 ↗
• InjurySep 15, 2022Fluid/Blood Leak; Fluid/Blood Leak

  PATIENT WAS 3 HOUR 15 MINUTES INTO A 4 HOUR HD TREATMENT WHEN STAFF STATED THEY OBSERVED BLOOD LEAKING FROM THE BLOOD PUMP SEGMENT ON THE MACHINE. REPORTED THAT HD TREATMENT WAS STOPPED AND THE BLOODLINE AND DIALYZER WAS THROWN AWAY. BLOOD WAS NOT RETURNED TO THE PATIENT. SHE REPORTED THAT THE PATIENT WAS STABLE DURING AND AFTER THE EVENT. PATIENT DID NOT REQUIRE ANY FURTHER MEDICAL ATTENTION RELATED TO THIS ISSUE. STAFF DID NOT RETAIN THE BLOODLINE FOR RETURN TO US.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15428111 ↗
• MalfunctionSep 15, 2022Fluid/Blood Leak; Fluid/Blood Leak

  PATIENT WAS 3 HOUR 15 MINUTES INTO A 4 HOUR HD TREATMENT WHEN STAFF STATED THEY OBSERVED BLOOD LEAKING FROM THE BLOOD PUMP SEGMENT ON THE MACHINE. REPORTED THAT HD TREATMENT WAS STOPPED AND THE BLOODLINE AND DIALYZER WAS THROWN AWAY. BLOOD WAS NOT RETURNED TO THE PATIENT. SHE REPORTED THAT THE PATIENT WAS STABLE DURING AND AFTER THE EVENT. PATIENT DID NOT REQUIRE ANY FURTHER MEDICAL ATTENTION RELATED TO THIS ISSUE. STAFF DID NOT RETAIN THE BLOODLINE FOR RETURN TO US.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 15427956 ↗
• InjuryMay 9, 2018Obstruction of Flow; Device Operational Issue; Obstruction of Flow; Device Operational Issue

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

  Patient problems: Diaphoresis; Syncope

  MAUDE report 7499625 ↗