NXSTAGE CARTRIDGE EXPRESS CAR-500Recalls & reported problems

Summary

The FDA's MAUDE database contains 26 adverse event reports that list this exact device (DI M535CAR5000), received between Nov 14, 2018 and Oct 17, 2024 — classified as 1 death, 8 injuries, 17 malfunctions.

The most frequently reported specific device problem is “Break” (11 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 25 most recent of 26 reports, in the reporter's own words as published by the FDA.

• MalfunctionOct 17, 2024Fluid/Blood Leak; Fluid/Blood Leak

  A REPORT WAS RECEIVED ON 22 SEP 2024 FROM THE CRITICAL CARE NURSE OF A PATIENT OF UNSPECIFIED PATHOLOGY, WHO STATED BLOOD WAS OBSERVED LEAKING FROM THE CARTRIDGE DURING A CONTINUOUS RENAL REPLACEMENT THERAPY (CRRT) ON (B)(6) 2024. ADDITIONAL INFORMATION WAS RECEIVED ON 26 SEP 2024 FROM THE NURSE WHO STATED THE PATIENT DID NOT EXPERIENCE ANY SYMPTOMS OR REQUIRE MEDICAL INTERVENTION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20473471 ↗
• MalfunctionMar 28, 2023Fluid/Blood Leak; No Apparent Adverse Event; Fluid/Blood Leak; No Apparent Adverse Event

  A REPORT WAS RECEIVED ON (B)(6) 2023 FROM THE RISK MANAGER OF A 61 YEAR OLD FEMALE CRITICAL CARE PATIENT, WHO STATED FLUID WAS OBSERVED LEAKING FROM THE CARTRIDGE 15 MINUTES INTO A CONTINUOUS VENO-VENOUS HEMOFILTRATION (CVVH) TREATMENT ON (B)(6) 2023. ADDITIONAL INFORMATION WAS RECEIVED UPON COMPLETION OF PRODUCT EVALUATION ON (B)(6) 2023 WHICH CONFIRMED BLOOD WAS LEAKING FROM THE CARTRIDGE. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION REGARDING PATIENT IMPACT WAS NOT PROVIDED, THERE IS NO INDICATION THE PATIENT EXPERIENCED ANY SYMPTOMS RELATED TO THE EVENT AND NO REPORT OF MEDICAL INTERVENTION BEING REQUIRED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16626792 ↗
• DeathMar 9, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A REPORT WAS RECEIVED ON (B)(6) 2022 FROM THE NURSE AT A CRITICAL CARE FACILITY REGARDING A MALE PATIENT WITH UNSPECIFIED PATHOLOGY WHO STATED AIR BUBBLES WERE OBSERVED ON THE ARTERIAL SIDE DURING A CONTINUOUS VENO-VENOUS HEMOFILTRATION (CVVH) TREATMENT ON (B)(6) 2022. THE PATIENT WAS DISCONNECTED, AND A FLUSH WAS PERFORMED, THE PATIENT WAS THEN RECONNECTED, UPON RESTARTING TREATMENT THE PATIENT CODED (NOS). NEW INFORMATION WAS RECEIVED ON 21 FEB 2023 FROM A RISK MANAGER WHO STATED, ADVANCED CARDIAC LIFE SUPPORT (NOS) WAS PERFORMED ON THE PATIENT AS A RESULT OF THE CODE AND THE PATIENT SUBSEQUENTLY EXPIRED.

  Patient problems: Cardiac Arrest

  MAUDE report 16511809 ↗
• MalfunctionMar 6, 2023Fluid/Blood Leak; No Apparent Adverse Event; Fluid/Blood Leak; No Apparent Adverse Event

  A REPORT WAS RECEIVED ON 13 FEB 2023 FROM THE DIRECTOR OF RISK MANAGEMENT AT A CRITICAL CARE FACILITY REGARDING A PATIENT WITH UNSPECIFIED PATHOLOGY, WHO STATED BLOOD WAS OBSERVED LEAKING OUTSIDE OF THE DIALYSIS CIRCUIT DURING A CONTINUOUS RENAL REPLACEMENT THERAPY (CRRT) TREATMENT ON AN UNSPECIFIED DATE. THERE WAS NO ADVERSE AFFECT OR MEDICAL INTERVENTION REPORTED. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION WAS NOT PROVIDED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16488619 ↗
• MalfunctionMar 6, 2023Fluid/Blood Leak; No Apparent Adverse Event; Fluid/Blood Leak; No Apparent Adverse Event

  A REPORT WAS RECEIVED ON (B)(6) 2023 FROM THE DIRECTOR OF RISK MANAGEMENT AT A CRITICAL CARE FACILITY REGARDING A PATIENT WITH UNSPECIFIED PATHOLOGY, WHO STATED BLOOD WAS OBSERVED LEAKING OUTSIDE THE DIALYSIS CIRCUIT DURING A CONTINUOUS RENAL REPLACEMENT THERAPY (CRRT) TREATMENT ON AN UNSPECIFIED DATE. THERE WAS NO ADVERSE AFFECT OR MEDICAL INTERVENTION REPORTED. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION WAS NOT PROVIDED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16487707 ↗
• MalfunctionJan 10, 2023Fluid/Blood Leak

  A REPORT WAS RECEIVED ON 15 DEC 2022 FROM THE CLINICAL MANAGER (CM) OF A CRITICAL CARE PATIENT WITH UNSPECIFIED PATHOLOGY, WHO STATED BLOOD WAS OBSERVED OUTSIDE OF THE DIALYSIS CIRCUIT DURING A CONTINUOUS RENAL REPLACEMENT THERAPY TREATMENT ON (B)(6) 2022. ADDITIONAL INFORMATION WAS RECEIVED ON 16 DEC 2022 FROM THE CM STATING THAT THERE WAS NO MEDICAL INTERVENTION AND THAT THE PATIENT CONTINUED TO TREAT WITH THE NXSTAGE SYSTEM.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16132369 ↗
• MalfunctionJan 10, 2023Fluid/Blood Leak

  A REPORT WAS RECEIVED ON 15 DEC 2022 FROM THE CLINICAL MANAGER (CM) OF A CRITICAL CARE PATIENT WITH UNSPECIFIED PATHOLOGY, WHO STATED BLOOD WAS OBSERVED OUTSIDE OF THE DIALYSIS CIRCUIT DURING A CONTINUOUS RENAL REPLACEMENT THERAPY TREATMENT ON (B)(6) 2022. ADDITIONAL INFORMATION WAS RECEIVED ON 16 DEC 2022 FROM THE CM STATING THAT THERE WAS NO MEDICAL INTERVENTION AND THAT THE PATIENT CONTINUED TO TREAT WITH THE NXSTAGE SYSTEM.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16132216 ↗
• InjuryJan 10, 2023Priming Problem

  A REPORT WAS RECEIVED ON 14 NOV 2022 FROM THE RISK MANAGER OF A PATIENT OF UNSPECIFIED PATHOLOGY, STATING ALARMS WERE UNABLE TO BE RESOLVED WHEN PRIMING FOR A CONTINUOUS VENO-VENOUS HEMOFILTRATION TREATMENT ON (B)(6) 2022. ADDITIONAL INFORMATION WAS RECEIVED ON 27 DEC 2022 FROM THE RISK MANAGER WHO STATED THE PATIENT RECEIVED "BLOOD PRODUCTS" DUE TO MULTIPLE FILTER CHANGES, WITH NO FURTHER DETAILS PROVIDED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 16132146 ↗
• InjuryAug 24, 2022Fluid/Blood Leak

  A REPORT WAS RECEIVED ON 10 AUG 2022 FROM THE CRITICAL CARE NURSE (CCN) OF A CRITICALLY ILL PATIENT WITH UNSPECIFIED PATHOLOGY, WHO STATED AN UNSPECIFIED AMOUNT OF BLOOD LEAKED APPROXIMATELY 24 HOURS INTO A CONTINUOUS RENAL REPLACEMENT THERAPY (CRRT) ON (B)(6) 2022. PER THE CCN, THE PATIENT EXPERIENCED A 1G/DL DECREASE IN HEMOGLOBIN, RECEIVED ONE UNIT OF BLOOD, RECOVERED TO BASELINE STATUS AND RESUMED CRRT.

  Patient problems: Anemia

  MAUDE report 15283368 ↗
• InjuryJun 15, 2022Insufficient Device Problem Information

  A REPORT WAS RECEIVED ON 07 JUN 2022 FROM THE RISK MANAGER OF A 71-YEAR-OLD MALE CRITICAL CARE PATIENT WITH UNSPECIFIED PATHOLOGY, WHO STATED THE PATIENT REQUIRED MULTIPLE FILTER CHANGES AND RECEIVED ¿BLOOD PRODUCTS¿ DURING A CONTINUOUS RENAL REPLACEMENT THERAPY TREATMENT ON 13 FEB 2022. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION WAS NOT PROVIDED.

  Patient problems: Insufficient Information

  MAUDE report 14694307 ↗
• InjuryAug 19, 2021Fluid/Blood Leak

  A REPORT WAS RECEIVED ON (B)(6) 2021 FROM THE RISK MANAGER OF A CRITICAL CARE FACILITY REGARDING A (B)(6) MALE PATIENT, WHO STATED THAT A THERAPY FLUID LEAK WAS PRESENT DURING A CONTINUOUS VENO-VENOUS HEMOFILTRATION (CVVH) TREATMENT ON (B)(6) 2021. THE PATIENT¿S BLOOD WAS UNABLE TO BE RETURNED AND THE PATIENT WAS GIVEN A TRANSFUSION OF UNIT OF PACKED RED BLOOD CELLS. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION HAS NOT BEEN PROVIDED.

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

  MAUDE report 12341276 ↗
• InjuryJul 1, 2021Adverse Event Without Identified Device or Use Problem

  A REPORT WAS RECEIVED ON 30 JUN 2021 FROM THE RISK MANAGER (RM) OF A (B)(6) MALE CRITICAL CARE PATIENT ADMITTED TO THE INTENSIVE CARE UNIT (ICU) FOR ACUTE ON CHRONIC KIDNEY FAILURE, SPONTANEOUS BACTERIAL PERITONITIS AND SHOCK, STATING THAT CONTINUOUS RENAL REPLACEMENT THERAPY (CRRT) WAS TERMINATED WITHOUT RINSEBACK AFTER TROUBLESHOOTING SYSTEM ALARMS, AND THE PATIENT EXPERIENCED AN ESTIMATED BLOOD LOSS OF 310ML ON (B)(6) 2021. THE PATIENT RECEIVED A BLOOD TRANSFUSION (NOS) SECONDARY TO A LOW HEMATOCRIT (VALUE NOT PROVIDED) LEVEL LATER IN THE DAY ON (B)(6) 2021. ADDITIONAL INFORMATION WAS RECEIVED ON 30 JUN 2021 FROM THE RM STATING THAT THE PATIENT RECOVERED TO BASELINE STATUS OF ADMISSION TO THE ICU AND WAS ABLE TO RESUME CRRT WITH NEW CARTRIDGE ON (B)(6) 2021.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Peritonitis; Shock

  MAUDE report 12100740 ↗
• InjuryApr 30, 2021Fluid/Blood Leak; Therapeutic or Diagnostic Output Failure; Air/Gas in Device

  A REPORT WAS RECEIVED ON (B)(6) 2021 FROM THE HEALTH PROFESSIONAL OF A (B)(6) CRITICAL CARE PATIENT WITH MULTIPLE COMORBIDITIES AND PNEUMONIA SECONDARY TO COVID-19, STATING THE PATIENT CODED WHILE CONNECTED TO UNSPECIFIED EQUIPMENT FOR EXTRACORPOREAL MEMBRANE OXYGENATION (ECMO) AND PERFORMING CONTINUOUS VENO-VENOUS HEMOFILTRATION (CVVH) THERAPY WITH THE NXSTAGE DEVICE ON (B)(6) 2021. ADDITIONAL INFORMATION WAS RECEIVED ON 22 APR 2021 FROM THE CARDIOVASCULAR INTENSIVE CARE UNIT NURSE MANAGER (NM) STATING THAT THE CVVH WAS CONNECTED TO THE PATIENT VIA DEDICATED ACCESS THAT LOST FUNCTIONALITY AND CVVH WAS SWITCHED TO RUN VIA THE ECMO CIRCUIT. ONCE CONNECTED TO THE ECMO, A "LARGE AMOUNT" OF AIR WAS ENTRAINED AND AN UNSPECIFIED AMOUNT OF BLOOD WAS NOTED ON THE FLOOR. AIR REMOVAL WAS SUCCESSFUL. AFTER THE CODE THE PATIENT RECEIVED TWO UNITS OF PACKED RED BLOOD CELLS, WAS NEUROLOGICALLY INTACT AND FOLLOWING COMMANDS.

  Patient problems: Cardiac Arrest

  MAUDE report 11757221 ↗
• InjuryJan 28, 2021Adverse Event Without Identified Device or Use Problem

  A REPORT WAS RECEIVED ON (B)(6) 2021 FROM THE NURSE OF A (B)(6) OLD FEMALE IN THE CRITICAL CARE UNIT STATUS POST CARDIAC ARREST WITH CARDIOGENIC SHOCK INCLUDING HYPOTENSION REQUIRING VASOACTIVE MEDICATIONS, WHO STATED THE PATIENT EXPERIENCED TACHYCARDIA AND HYPOTENSION APPROXIMATELY FIVE MINUTES INTO THEIR FIRST CONTINUOUS RENAL REPLACEMENT THERAPY (CRRT) SESSION ON (B)(6) 2021. ADDITIONAL INFORMATION WAS RECEIVED ON 12 JAN 2021 FROM THE NURSE WHO STATED THE PATIENT ALSO DESATURATED, WITH OXYGEN (O2) LEVELS DECREASING FROM 99-100% TO 40-60%. SYMPTOMS IMPROVED WITH ADMINISTRATION OF 1 MG INTRAVENOUS EPINEPHRINE, SODIUM BICARBONATE (DOSE NOT PROVIDED) AND 100% FIO2. THE PATIENT WAS RECHALLENGED WITH THE DEVICE LATER THAT DAY, AFTER BEING PREMEDICATED WITH INTRAVENOUS DIPHENHYDRAMINE, METHYLPREDNISOLONE AND FAMOTIDINE, DOSES UNSPECIFIED AND EXPERIENCED NO FURTHER REACTION.

  Patient problems: Low Blood Pressure/ Hypotension; Low Oxygen Saturation; Reaction; Tachycardia

  MAUDE report 11242944 ↗
• MalfunctionDec 23, 2020Break

  A REPORT WAS RECEIVED ON (B)(6) 2020 FROM THE NURSE OF A CRITICAL CARE PATIENT WITH UNSPECIFIED PATHOLOGY, WHO STATED THE CARTRIDGE VENOUS LINE LUER BROKE WITHIN THE PATIENT'S CENTRAL VENOUS CATHETER (CVC) DURING A CONTINUOUS RENAL REPLACEMENT THERAPY (CRRT) TREATMENT ON (B)(6) 2020, THERE WAS NO INDICATION OF ADVERSE IMPACT TO PATIENT AND NO REPORT OF MEDICAL INTERVENTION BEING REQUIRED.

  Patient problems: Insufficient Information

  MAUDE report 11067253 ↗
• MalfunctionDec 23, 2020Break

  A REPORT WAS RECEIVED ON (B)(6) 2020 FROM THE NURSE OF A CRITICAL CARE PATIENT WITH UNSPECIFIED PATHOLOGY, WHO STATED THE CARTRIDGE VENOUS LINE LUER BROKE DURING A CONTINUOUS RENAL REPLACEMENT THERAPY (CRRT) TREATMENT ON (B)(6) 2020, THERE WAS NO INDICATION OF ADVERSE IMPACT TO PATIENT AND NO REPORT OF MEDICAL INTERVENTION BEING REQUIRED.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11067202 ↗
• MalfunctionDec 23, 2020Break

  A REPORT WAS RECEIVED ON (B)(6) 2020 FROM THE NURSE OF A CRITICAL CARE PATIENT WITH UNSPECIFIED PATHOLOGY, WHO STATED THE CARTRIDGE VENOUS LINE LUER BROKE DURING A CONTINUOUS RENAL REPLACEMENT THERAPY (CRRT) TREATMENT ON (B)(6) 2020, THERE WAS NO INDICATION OF ADVERSE IMPACT TO THE PATIENT AND NO REPORT OF MEDICAL INTERVENTION.

  Patient problems: No Clinical Signs, Symptoms or Conditions

  MAUDE report 11067189 ↗
• MalfunctionDec 23, 2020Break

  A REPORT WAS RECEIVED ON 03 DEC 2020 FROM THE NURSE OF A CRITICAL CARE PATIENT WITH UNSPECIFIED PATHOLOGY, WHO STATED THE CARTRIDGE VENOUS LINE LUER BROKE DURING A CONTINUOUS RENAL REPLACEMENT THERAPY (CRRT) TREATMENT ON (B)(6) 2020, THERE WAS NO INDICATION OF ADVERSE IMPACT TO THE PATIENT AND NO REPORT OF MEDICAL INTERVENTION.

  Patient problems: Insufficient Information

  MAUDE report 11067090 ↗
• MalfunctionDec 20, 2019Break

  A REPORT WAS RECEIVED ON (B)(6) 2019 FROM THE NURSE OF A CRITICAL CARE PATIENT WITH UNSPECIFIED PATHOLOGY REQUIRING A LIVER TRANSPLANT, STATING THE ARTERIAL LINE CONNECTOR BROKE AT AN UNSPECIFIED TIME DURING HEMODIALYSIS THERAPY ON (B)(6) 2019. THE CATHETER WAS REPLACED SURGICALLY IN THE OPERATING ROOM WITH NO ASSOCIATED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9505402 ↗
• MalfunctionDec 20, 2019Break

  A REPORT WAS RECEIVED ON (B)(6) 2019 FROM THE NURSE OF A CRITICAL CARE PATIENT WITH UNSPECIFIED PATHOLOGY, STATING THAT THE LUER CONNECTION BROKE ON (B)(6) 2019. THE PATIENT'S CENTRAL VENOUS CATHETER WAS REPLACED WITH NO ASSOCIATED PATIENT INJURY.

  Patient problems: No Consequences Or Impact To Patient

  MAUDE report 9505034 ↗
• MalfunctionDec 18, 2019Break

  A REPORT WAS RECEIVED ON (B)(6) 2019 FROM THE NURSE OF A (B)(6) YEAR OLD MALE IN CRITICAL CARE WITH UNSPECIFIED PATHOLOGY, STATING THE LUER CONNECTOR BROKE WITHIN THE PATIENT¿S CENTRAL VENOUS CATHETER (CVC) AT AN UNSPECIFIED TIME DURING HEMODIALYSIS THERAPY ON (B)(6) 2019. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2019 FROM THE NURSE WHO STATED THE CVC REQUIRED REPLACEMENT. THERE WAS NO ASSOCIATED PATIENT INJURY.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9491198 ↗
• MalfunctionDec 12, 2019Break

  A REPORT WAS RECEIVED ON 19 NOV 2019 FROM THE NURSE OF A (B)(6) MALE IN CRITICAL CARE FOR UNSPECIFIED PATHOLOGY, STATING THE CARTRIDGE VENOUS LINE LUER BROKE WITHIN THE PATIENT¿S CENTRAL VENOUS CATHETER (CVC) WHEN DISCONNECTING FROM A CONTINUOUS RENAL REPLACEMENT THERAPY (CRRT) TREATMENT ON (B)(6) 2019. ADDITIONAL INFORMATION WAS RECEIVED ON 21 NOV 2019 FROM THE NURSE STATING THE BROKEN PIECE WAS REMOVED AND THE CATHETER WAS REPAIRED WITH ASSISTANCE FROM RADIOLOGY TO ENSURE FURTHER TREATMENT COULD BE CONDUCTED. THERE WAS NO REPORT OF SYMPTOMS OR ADDITIONAL MEDICAL INTERVENTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 9459858 ↗
• MalfunctionMay 31, 2019Break

  A REPORT WAS RECEIVED ON 17 MAY 2019 FROM THE RISK MANAGER, REGARDING A (B)(6) YEAR OLD FEMALE PATIENT IN CRITICAL CARE WHO RECEIVED CONTINUOUS RENAL REPLACEMENT THERAPY (CRRT) ON (B)(6) 2019 AND THE CARTRIDGE ARTERIAL LINE LUER BROKE WITHIN THE PATIENT''S CENTRAL VENOUS CATHETER. THE CATHETER WAS REPLACED WITH NO REPORT OF SYMPTOMS OR ADDITIONAL MEDICAL INTERVENTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8657697 ↗
• MalfunctionMay 30, 2019Break

  A REPORT WAS RECEIVED ON (B)(6) 2019 FROM THE RISK MANAGER, REGARDING A (B)(6) FEMALE PATIENT IN CRITICAL CARE WHO RECEIVED CONTINUOUS RENAL REPLACEMENT THERAPY (CRRT) ON (B)(6) 2019 AND THE CARTRIDGE ARTERIAL LINE LUER BROKE WITHIN THE PATIENT CENTRAL VENOUS CATHETER. THE CATHETER WAS REPLACED WITH NO REPORT OF SYMPTOMS OR ADDITIONAL MEDICAL INTERVENTION.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8656397 ↗
• MalfunctionNov 23, 2018Crack; Leak/Splash

  DURING USE, NXSTAGE CARTRIDGE TUBING WAS LEAKING. CRACK IN THE TUBING.

  Patient problems: No Known Impact Or Consequence To Patient

  MAUDE report 8099769 ↗