NXSTAGE CARTRIDGE EXPRESS CAR-170-CRecalls & reported problems

Summary

The FDA's MAUDE database contains 57 adverse event reports that list this exact device (DI M535CAR170C0), received between Aug 8, 2018 and Mar 10, 2026 — classified as 33 injuries, 24 malfunctions.

The most frequently reported specific device problem is “Fluid/Blood Leak” (23 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 57 reports, in the reporter's own words as published by the FDA.

• InjuryMar 10, 2026Adverse Event Without Identified Device or Use Problem

  A REPORT WAS RECEIVED ON (B)(4) 2026 FROM THE HOME THERAPY NURSE (HTN) OF A 75 YEAR OLD FEMALE PATIENT WITH A MEDICAL HISTORY INCLUDING END STAGE RENAL DISEASE, WHO STATED THE PATIENT EXPERIENCED HIVES, ITCHING, AND DIFFICULTY BREATHING APPROXIMATELY TEN MINUTES INTO A HEMODIALYSIS TREATMENT ON (B)(4) 2026. TREATMENT WAS TERMINATED WITH RINSEBACK. ADDITIONAL INFORMATION WAS RECEIVED FROM THE HOME THERAPY MANAGER (HTM) WHO STATED SYMPTOMS RESOLVED APPROXIMATELY TEN MINUTES AFTER ADMINISTERING OXYGEN, 125MG INTRAVENOUS METHYLPREDNISOLONE (SOLU-MEDROL), AND 50MG ORAL DIPHENHYDRAMINE (BENADRYL). PER THE HTM, THE PATIENT RECOVERED WITHOUT SEQUELAE AND CONTINUES TO TREAT WITH THE NXSTAGE SYSTEM.

  Patient problems: Dyspnea; Hypersensitivity/Allergic reaction; Itching Sensation; Urticaria

  MAUDE report 24558321 ↗
• InjuryMar 10, 2026Adverse Event Without Identified Device or Use Problem

  A REPORT WAS RECEIVED ON 04 MAR 2026 FROM THE HOME THERAPY NURSE (HTN) OF A 75 YEAR OLD FEMALE PATIENT WITH A MEDICAL HISTORY INCLUDING HYPERTENSION AND END STAGE RENAL DISEASE, WHO STATED THE PATIENT EXPERIENCED HIVES, ITCHINESS AND DIFFICULTY BREATHING DURING A IN-CENTER HEMODIALYSIS TREATMENT ON (B)(6) 2026. ADDITIONAL INFORMATION WAS RECEIVED ON 06 MAR 2026 FROM THE HTN WHO STATED THE PATIENT WAS ADMINISTERED OXYGEN, METHYLPREDNISOLONE (SOLU-MEDROL) 125MG, AND DIPHENHYDRAMINE (BENADRYL) 50MG INTRAVENOUSLY. THE PATIENT WAS SENT TO THE EMERGENCY ROOM, EVALUATED AND DISCHARGED. FOLLOWING THE EVENT, THE PATIENT RECOVERED WITHOUT SEQUELAE AND CONTINUES TO TREAT WITH THE NXSTAGE SYSTEM.

  Patient problems: Dyspnea; Hypersensitivity/Allergic reaction; Itching Sensation; Urticaria

  MAUDE report 24557754 ↗
• InjuryAug 27, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A REPORT WAS RECEIVED ON 22 AUG 2025 FROM THE NURSE OF A 62-YEAR-OLD MALE PATIENT WITH A MEDICAL HISTORY INCLUDING END STAGE RENAL DISEASE, WHO STATED THE PATIENT'S BLOOD PRESSURE DROPPED (68/48 MMHG) AND HE EXPERIENCED ITCHING WITHIN THE FIRST FIVE MINUTES OF AN IN-CENTER HEMODIALYSIS TREATMENT ON (B)(6) 2025. ADDITIONAL INFORMATION WAS RECEIVED ON 25 AUG 2025 FROM THE HOME THERAPY NURSE (HTN) WHO STATED THE PATIENT WAS ALSO LETHARGIC AND SWEATING. TREATMENT WAS TERMINATED AND EMERGENCY MEDICAL SERVICES (EMS) WERE CALLED, 50MG INTRAVENOUS DIPHENHYDRAMINE (BENADRYL), A SALINE BOLUS AND ORAL GLUCOSE WERE ADMINISTERED TO THE PATIENT. EMS ARRIVED ON SCENE, OXYGEN WAS GIVEN TO THE PATIENT, HE WAS TRANSPORTED TO THE HOSPITAL AND ADMITTED. PER THE HTN, THE PATIENT WAS DISCHARGED IN STABLE CONDITION ON (B)(6) 2025 AND HAS RESUMED THERAPY WITH THE NXSTAGE SYSTEM.

  Patient problems: Diaphoresis; Hypersensitivity/Allergic reaction; Lethargy; Low Blood Pressure/ Hypotension

  MAUDE report 22903737 ↗
• InjuryApr 21, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A REPORT WAS RECEIVED ON (B)(6) 2025 FROM THE NURSE OF A 56-YEAR-OLD MALE PATIENT WITH A MEDICAL HISTORY INCLUDING END STAGE RENAL DISEASE, WHO STATED THE PATIENT WAS ITCHY APPROXIMATELY ONE HOUR INTO A HEMODIALYSIS TREATMENT ON (B)(6) 2025. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2025 FROM THE NURSE WHO STATED THE PATIENT ALSO EXPERIENCED HIVES AND WAS ADMINISTERED 50MG INTRAVENOUS DIPHENHYDRAMINE (BENADRYL). PER THE NURSE, THE PATIENT CONTINUES TO TREAT WITH NXSTAGE.

  Patient problems: Hypersensitivity/Allergic reaction; Local Reaction; Urticaria

  MAUDE report 21872242 ↗
• MalfunctionMar 7, 2025Fluid/Blood Leak; Fluid/Blood Leak

  A REPORT WAS RECEIVED ON 10 FEB 2025 FROM A 44 YEAR OLD FEMALE PATIENT WITH A MEDICAL HISTORY INCLUDING END STAGE RENAL DISEASE, WHO STATED THEY OBSERVED AN UNSPECIFIED AMOUNT OF BLOOD LEAKING FROM THE CARTRIDGE DURING A HOME HEMODIALYSIS TREATMENT ON (B)(6) 2025. ADDITIONAL INFORMATION WAS RECEIVED ON 12 FEB 2025 FROM THE HOME THERAPY NURSE (HTN) WHO STATED THE PATIENT DID NOT EXPERIENCE ANY SYMPTOMS AND NO MEDICAL INTERVENTION WAS REQUIRED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 21547934 ↗
• InjuryFeb 11, 2025Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A REPORT WAS RECEIVED ON 20 JAN 2025 FROM THE HOME THERAPY NURSE (HTN) OF A 72 YEAR OLD FEMALE PATIENT WITH A MEDICAL HISTORY INCLUDING END STAGE RENAL DISEASE, WHO STATED THE PATIENT BEGAN SNEEZING AND BECAME FLUSHED AND DIAPHORETIC AT THE START OF AN IN-CENTER HEMODIALYSIS TREATMENT ON (B)(6) 2025. TREATMENT WAS ENDED AND THE PATIENT EXPERIENCED VOMITING AND DECREASED BLOOD PRESSURE (60/42 MMHG). A SALINE BOLUS (200CC) WAS ADMINISTERED AND THE PATIENT WAS TRANSPORTED TO HOSPITAL VIA EMERGENCY MEDICAL SERVICES (EMS). ADDITIONAL INFORMATION WAS RECEIVED ON 22 JAN 2025 FROM THE HTN WHO STATED THE PATIENT ALSO EXPERIENCED DIZZINESS. THE PATIENT WAS ADMITTED TO HOSPITAL WITH A PRIMARY DIAGNOSIS OF SYNCOPE AND DISCHARGED ON (B)(6) 2025. FOLLOWING THE EVENT THE PATIENT HAS DISCONTINUED TREATMENT WITH THE NXSTAGE SYSTEM.

  Patient problems: Dizziness; Hot Flashes/Flushes; Hypersensitivity/Allergic reaction; Low Blood Pressure/ Hypotension; Sneezing; Vomiting

  MAUDE report 21356794 ↗
• MalfunctionSep 10, 2024Fluid/Blood Leak; Fluid/Blood Leak

  A REPORT WAS RECEIVED ON 16 AUG 2024 FROM THE CAREGIVER (CG) OF A 57-YEAR-OLD FEMALE PATIENT WITH A MEDICAL HISTORY INCLUDING HYPERTENSION AND END STAGE RENAL DISEASE, WHO STATED BLOOD WAS OBSERVED LEAKING FROM THE CARTRIDGE DURING A HOME HEMODIALYSIS TREATMENT ON (B)(6) 2024. TREATMENT WAS TERMINATED WITHOUT RINSEBACK. THERE IS NO REPORT OF MEDICAL INTERVENTION BEING REQUIRED. ADDITIONAL INFORMATION WAS RECEIVED ON 19 AUG 2024 FROM THE HOME THERAPY NURSE (HTN) WHO STATED THERE WERE NO SYMPTOMS OR MEDICAL INTERVENTION. THE PATIENT CONTINUES TO TREAT WITH THE NXSTAGE SYSTEM.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 20185337 ↗
• InjuryAug 7, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A REPORT WAS RECEIVED ON 30 JUL 2024 FROM THE HOME THERAPY NURSE (HTN) REGARDING A 63 YEAR OLD MALE PATIENT WITH A MEDICAL HISTORY INCLUDING HYPERTENSION AND END STAGE RENAL DISEASE, STATING THE PATIENT EXPERIENCED ITCHING AT THE START OF A HEMODIALYSIS TREATMENT ON (B)(6) 2024. ADDITIONAL INFORMATION WAS RECEIVED ON 30 JUL 2024 FROM THE HOME THERAPY NURSE (HTN) DIPHENHYDRAMINE (BENADRYL) INTRAVENOUS 25MG WAS ADMINISTERED, WITH ITCHINESS RESOLVING. FOLLOWING THE EVENT, THE PATIENT HAS RECOVERED WITHOUT SEQUELAE AND CONTINUES TO TREAT USING THE NXSTAGE SYSTEM.

  Patient problems: Hypersensitivity/Allergic reaction; Itching Sensation

  MAUDE report 19928971 ↗
• MalfunctionJul 10, 2024Fluid/Blood Leak; No Apparent Adverse Event; Fluid/Blood Leak; No Apparent Adverse Event

  A REPORT WAS RECEIVED ON 25 JUN 2024 FROM A 50-YEAR-OLD MALE PATIENT WITH A MEDICAL HISTORY INCLUDING END STAGE RENAL DISEASE, WHO STATED BLOOD WAS OBSERVED LEAKING FROM THE CARTRIDGE DURING A HOME HEMODIALYSIS TREATMENT ON (B)(6) 2024. THERE WAS NO REPORT OF MEDICAL INTERVENTION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 19714475 ↗
• InjuryJul 3, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A REPORT WAS RECEIVED ON 21 JUN 2024 FROM THE CAREGIVER OF A 78 YEAR OLD FEMALE PATIENT WITH A MEDICAL HISTORY INCLUDING ANAPHYLACTIC SHOCK AND END STAGE RENAL DISEASE, WHO STATED THE PATIENT EXPERIENCED LOW BLOOD PRESSURE (NOS) AND BECAME UNRESPONSIVE DURING INITIATION OF HER FIRST HEMODIALYSIS TREATMENT WITH THE DEVICE ON (B)(6) 2024. THE PATIENT WAS TRANSPORTED TO HOSPITAL ON (B)(6) 2024. ADDITIONAL INFORMATION WAS RECEIVED ON 27 JUN 2024 FROM THE HOME THERAPY NURSE (HTN) STATING RINSEBACK WAS PERFORMED, OXYGEN WAS GIVEN, AND INTRAVENOUS SALINE WAS ADMINISTERED. ADDITIONAL SYMPTOMS INCLUDED VOMITING, TREMORS, GENERALIZED PRESSURE IN THE CHEST, BACK, NECK AND THROAT AND ALTERED SENSATION IN THE LOWER EXTREMITIES. THE PATIENT WAS OBSERVED IN THE EMERGENCY DEPARTMENT AT THE HOSPITAL AND RELEASED WITH NO ADDITIONAL MEDICAL INTERVENTION REPORTED ON (B)(6) 2024. PER THE HTN, THE PATIENT HAS RESUMED THERAPY WITH A DIALYZER FROM A DIFFERENT MANUFACTURER.

  Patient problems: Discomfort; Hypersensitivity/Allergic reaction; Low Blood Pressure/ Hypotension; Shaking/Tremors; Syncope/Fainting; Vomiting

  MAUDE report 19665745 ↗
• MalfunctionApr 19, 2024Fluid/Blood Leak; No Apparent Adverse Event; Fluid/Blood Leak; No Apparent Adverse Event

  A REPORT WAS RECEIVED ON 10 APR 2024 FROM A 58-YEAR-OLD FEMALE PATIENT WITH A MEDICAL HISTORY INCLUDING HYPERTENSION AND END STAGE RENAL DISEASE, WHO STATED BLOOD LEAKED DURING HEMODIALYSIS TREATMENT ON AN UNSPECIFIED DATE. ADDITIONAL INFORMATION WAS RECEIVED ON 15 APR 2024 FROM THE HOME THERAPY NURSE (HTN) WHO STATED THE PATIENT DID NOT EXPERIENCE ANY SYMPTOMS OR REQUIRE MEDICAL INTERVENTION. FOLLOWING THE EVENT THE PATIENT CONTINUES TO TREAT USING THE NXSTAGE SYSTEM.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 19145220 ↗
• InjuryApr 11, 2024Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A REPORT WAS RECEIVED ON 09 APR 2024 FROM THE HOME THERAPY NURSE (HTN) OF 69 YEAR OLD MALE PATIENT WITH A MEDICAL HISTORY OF END STAGE RENAL DISEASE, STATING THE PATIENT EXPERIENCED PRURITUS AND URTICARIA DURING A HEMODIALYSIS TREATMENT ON (B)(6) 2024. ADDITIONAL INFORMATION WAS RECEIVED ON 09 APR 2024 FROM THE HOME THERAPY NURSE (HTN) STATING TREATMENT WAS TERMINATED WITH RINSEBACK. SYMPTOMS RESOLVED FOLLOWING INTRAVENOUS METHYLPREDNISOLONE (SOLU-MEDROL, DOSE NOT PROVIDED) AND ORAL DIPHENHYDRAMINE (BENADRYL, 50MG). THE PATIENT ELECTED TO RETURN TO THE DIALYSIS FACILITY FOR HEMODIALYSIS TREATMENT LATER THAT DAY WITH NO SYMPTOMS REPORTED.

  Patient problems: Hypersensitivity/Allergic reaction; Itching Sensation; Urticaria

  MAUDE report 19091208 ↗
• MalfunctionMar 27, 2024Fluid/Blood Leak; No Apparent Adverse Event; Fluid/Blood Leak; No Apparent Adverse Event

  A REPORT WAS RECEIVED ON 09 MAR 2024 FROM THE CAREGIVER OF AN 83 YEAR OLD MALE PATIENT WITH A MEDICAL HISTORY INCLUDING END STAGE RENAL DISEASE, WHO STATED A CARTRIDGE BLOOD LEAK WAS OBSERVED DURING A HOME HEMODIALYSIS TREATMENT ON (B)(6) 2024. ADDITIONAL INFORMATION WAS RECEIVED ON 18 MAR 2024 FROM THE HOME THERAPY NURSE (HTN) WHO CONFIRMED THE PATIENT CONTINUES TO PERFORM THERAPY WITH THE NXSTAGE SYSTEM. THERE WAS NO REPORT OF MEDICAL INTERVENTION OR ADVERSE IMPACT TO THE PATIENT.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18986618 ↗
• MalfunctionMar 7, 2024Fluid/Blood Leak; No Apparent Adverse Event; Fluid/Blood Leak; No Apparent Adverse Event

  A REPORT WAS RECEIVED ON 22 FEB 2024 FROM A 58 YEAR OLD FEMALE PATIENT WITH A MEDICAL HISTORY INCLUDING DIABETES AND END STAGE RENAL DISEASE, WHO STATED A BLOOD LEAK WAS OBSERVED DURING A HOME HEMODIALYSIS TREATMENT ON (B)(6) 2024. ADDITIONAL INFORMATION WAS RECEIVED ON 27 FEB 2024 FROM THE HOME THERAPY NURSE (HTN) WHO STATED THE PATIENT EXPERIENCED A DECREASE IN BLOOD PRESSURE (NOS) AND UNSPECIFIED BLOODWORK WAS PERFORMED. THERE WAS NO REPORT OF MEDICAL INTERVENTION AND FOLLOWING THE EVENT, THE PATIENT CONTINUES TO TREAT WITH THE NXSTAGE SYSTEM.

  Patient problems: Hemorrhage/Blood Loss/Bleeding; Low Blood Pressure/ Hypotension

  MAUDE report 18860653 ↗
• MalfunctionDec 20, 2023Fluid/Blood Leak; No Apparent Adverse Event; Fluid/Blood Leak; No Apparent Adverse Event

  A REPORT WAS RECEIVED ON 29 NOV 2023 FROM A (B)(6) FEMALE PATIENT WITH A MEDICAL HISTORY INCLUDING DIABETES AND END STAGE RENAL DISEASE, WHO STATED A CARTRIDGE BLOOD LEAK WAS OBSERVED DURING A HOME HEMODIALYSIS TREATMENT ON (B)(6) 2023. ALTHOUGH REQUESTED, ADDITIONAL INFORMATION WAS NOT PROVIDED. THERE IS NO INDICATION THE PATIENT EXPERIENCED SYMPTOMS RELATED TO THE EVENT AND THERE WAS NO REPORT OF MEDICAL INTERVENTION BEING REQUIRED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18365965 ↗
• MalfunctionDec 12, 2023Fluid/Blood Leak; No Apparent Adverse Event; Fluid/Blood Leak; No Apparent Adverse Event

  A REPORT WAS RECEIVED ON 20 NOV 2023 FROM THE HOME THERAPY NURSE (HTN) OF A 65 YEAR OLD MALE PATIENT WITH A MEDICAL HISTORY INCLUDING DIABETES AND END STAGE RENAL DISEASE, WHO STATED A CARTRIDGE BLOOD LEAK WAS OBSERVED DURING A HOME HEMODIALYSIS TREATMENT ON (B)(6) 2023. ADDITIONAL INFORMATION WAS RECEIVED ON 30 NOV 2023 FROM THE HTN WHO STATED THE PATIENT DID NOT EXPERIENCE ANY SYMPTOMS OR REQUIRE MEDICAL INTERVENTION. FOLLOWING THE EVENT THE PATIENT CONTINUES TO TREAT USING THE NXSTAGE SYSTEM.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 18310203 ↗
• InjuryOct 27, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A REPORT WAS RECEIVED ON (B)(6) 2023 FROM THE HOME THERAPY NURSE (HTN) OF A MALE PATIENT WITH A MEDICAL HISTORY INCLUDING END STAGE RENAL DISEASE, WHO STATED THE PATIENT EXPERIENCED ITCHING AND A SCRATCHY THROAT DURING AN IN-CENTER HEMODIALYSIS TREATMENT ON (B)(6) 2023. INTRAVENOUS DIPHENHYDRAMINE (BENADRYL) 25MG WAS ADMINISTERED. ADDITIONAL INFORMATION WAS RECEIVED ON 23 OCT 2023 FROM THE HTN WHO STATED THE PATIENT DID NOT EXPERIENCE ADDITIONAL SYMPTOMS OR REQUIRE ADDITIONAL MEDICAL INTERVENTION. FOLLOWING THE EVENT THE PATIENT HAS RECOVERED WITHOUT SEQUELAE AND CONTINUES TO TREAT USING THE NXSTAGE SYSTEM.

  Patient problems: Hypersensitivity/Allergic reaction; Itching Sensation

  MAUDE report 18020252 ↗
• InjuryOct 17, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A REPORT WAS RECEIVED ON (B)(6) 2023 FROM THE CAREGIVER OF A 52 YEAR OLD MALE PATIENT WITH A MEDICAL HISTORY INCLUDING HYPERTENSION AND END STAGE RENAL DISEASE WHO STATED THE PATIENT PREVIOUSLY HAD A HYPERSENSITIVITY TYPE RESPONSE DURING HEMODIALYSIS THERAPY, DATE NOT PROVIDED. ADDITIONAL INFORMATION WAS RECEIVED ON 06 OCT 2023 FROM THE HOME THERAPY NURSE (HTN), WHO STATED THE PATIENT EXPERIENCED GENERALIZED URTICARIA WITHIN FIVE MINUTES OF BEGINNING HIS FIRST IN-CENTER HEMODIALYSIS TREATMENT ON (B)(6) 2023. PER THE HTN, THE PATIENT WAS TREATED WITH 25MG OF INTRAVENOUS DIPHENHYDRAMINE (BENADRYL) AND SYMPTOMS RESOLVED. THE PATIENT CONTINUES TO WITH NXSTAGE THERAPY AND NO FURTHER HYPERSENSITIVITY TYPE REACTIONS HAVE BEEN REPORTED.

  Patient problems: Hypersensitivity/Allergic reaction; Urticaria

  MAUDE report 17948375 ↗
• MalfunctionOct 5, 2023Fluid/Blood Leak; No Apparent Adverse Event; Fluid/Blood Leak; No Apparent Adverse Event

  A REPORT WAS RECEIVED ON (B)(6) 2023 FROM A 58 YEAR OLD MALE PATIENT WITH A MEDICAL HISTORY INCLUDING DIABETES AND END STAGE RENAL DISEASE, WHO STATED A CARTRIDGE BLOOD LEAK WAS OBSERVED DURING A HOME HEMODIALYSIS TREATMENT ON (B)(6) 2023. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2023 FROM THE HOME THERAPY NURSE (HTN) WHO STATED THERE WERE NO SYMPTOMS OR MEDICAL INTERVENTION REQUIRED AND THE PATIENT CONTINUES TO TREAT WITH THE NXSTAGE SYSTEM.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17880152 ↗
• MalfunctionSep 28, 2023Fluid/Blood Leak; No Apparent Adverse Event; Fluid/Blood Leak; No Apparent Adverse Event

  A REPORT WAS RECEIVED ON (B)(6) 2023 FROM A 58 YEAR OLD MALE PATIENT WITH A MEDICAL HISTORY INCLUDING DIABETES AND END STAGE RENAL DISEASE, WHO STATED A CARTRIDGE BLOOD LEAK WAS OBSERVED DURING A HOME HEMODIALYSIS TREATMENT ON (B)(6) 2023. ADDITIONAL INFORMATION WAS RECEIVED ON 20 SEP 2023 FROM THE HOME THERAPY NURSE (HTN) WHO STATED THERE WERE NO SYMPTOMS OR MEDICAL INTERVENTION REQUIRED AND THE PATIENT CONTINUES TO TREAT WITH THE NXSTAGE SYSTEM.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17835437 ↗
• InjurySep 15, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A REPORT WAS RECEIVED ON (B)(6) 2023 FROM THE NURSE OF A 40 YEAR OLD MALE PATIENT WITH A MEDICAL HISTORY INCLUDING END STAGE RENAL DISEASE, WHO STATED THE PATIENT EXPERIENCED AN ALLERGIC REACTION WITH SWOLLEN LIPS, ITCHING, AND A RASH 30 MINUTES INTO AN IN-CENTER HEMODIALYSIS TREATMENT ON (B)(6) 2023. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2023 FROM THE NURSE WHO STATED INTRAVENOUS DIPHENHYDRAMINE (BENADRYL) 50MG AND INTRAVENOUS METHYLPREDNISOLONE (SOLUMEDROL) 125MG WAS ADMINISTERED WITH SYMPTOMS RESOLVING AFTER AN HOUR. FOLLOWING THE EVENT THE PATIENT HAS RECOVERED WITHOUT SEQUELAE AND WILL RESUME TREATMENT WITH THE NXSTAGE SYSTEM.

  Patient problems: Hypersensitivity/Allergic reaction; Itching Sensation; Swelling/ Edema; Urticaria

  MAUDE report 17754547 ↗
• MalfunctionSep 1, 2023Fluid/Blood Leak; No Apparent Adverse Event; Fluid/Blood Leak; No Apparent Adverse Event

  A REPORT WAS RECEIVED ON (B)(6) 2023 FROM THE CAREGIVER OF A 76 YEAR OLD MALE PATIENT WITH A MEDICAL HISTORY INCLUDING DIABETES AND END STAGE RENAL DISEASE, WHO STATED BLOOD WAS OBSERVED LEAKING FROM THE CARTRIDGE DURING A HOME HEMODIALYSIS TREATMENT ON (B)(6) 2023. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2023 FROM THE HOME THERAPY NURSE (HTN) WHO STATED THE PATIENT DID NOT EXPERIENCE ANY SYMPTOMS OR REQUIRE MEDICAL INTERVENTION. FOLLOWING THE EVENT THE PATIENT CONTINUES TO TREAT USING THE NXSTAGE SYSTEM.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17671428 ↗
• MalfunctionJun 2, 2023Fluid/Blood Leak; No Apparent Adverse Event; Fluid/Blood Leak; No Apparent Adverse Event

  A REPORT WAS RECEIVED ON (B)(6) 2023 FROM A 62 YEAR OLD MALE PATIENT WITH A MEDICAL HISTORY INCLUDING HYPERTENSION AND END STAGE RENAL DISEASE, WHO STATED BLOOD WAS OBSERVED LEAKING FROM THE CARTRIDGE DURING A HEMODIALYSIS TREATMENT ON (B)(6) 2023. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2023 FROM THE HOME THERAPY NURSE (HTN) WHO STATED THE PATIENT DID NOT EXPERIENCE ANY SYMPTOMS AND DID NOT REQUIRE ANY MEDICAL INTERVENTION.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 17049504 ↗
• InjuryMay 19, 2023Adverse Event Without Identified Device or Use Problem; Adverse Event Without Identified Device or Use Problem

  A REPORT WAS RECEIVED ON (B)(6) 2023 FROM THE HOME THERAPY NURSE (HTN) OF A 68-YEAR-OLD FEMALE PATIENT WITH A MEDICAL HISTORY INCLUDING DIABETES AND END STAGE RENAL DISEASE, WHO STATED THE PATIENT EXPERIENCED LOW BLOOD PRESSURE (NOS), HEADACHE AND VOMITED ONCE DURING A HEMODIALYSIS TREATMENT ON (B)(6) 2023. A SALINE BOLUS WAS GIVEN. THERE IS NO REPORT OF MEDICAL INTERVENTION BEING REQUIRED. ADDITIONAL INFORMATION WAS RECEIVED ON (B)(6) 2023 FROM THE HOME THERAPY NURSE (HTN) STATING THAT THE PATIENT''S LOW BLOOD PRESSURE LED TO THE HEADACHE. PER THE HTN, THE PATIENT DID NOT REQUIRE MEDICAL INTERVENTION, RECOVERED WITHOUT SEQUELAE AND CONTINUES TO TREAT WITH THE NXSTAGE SYSTEM.

  Patient problems: Headache; Hypersensitivity/Allergic reaction; Low Blood Pressure/ Hypotension; Vomiting

  MAUDE report 16965611 ↗
• MalfunctionMar 7, 2023Fluid/Blood Leak; No Apparent Adverse Event; Fluid/Blood Leak; No Apparent Adverse Event

  A REPORT WAS RECEIVED ON 20 FEB 2023 FROM A 79 YEAR OLD MALE PATIENT WITH A MEDICAL HISTORY INCLUDING HYPERTENSION AND END STAGE RENAL DISEASE, WHO STATED BLOOD WAS OBSERVED LEAKING FROM THE VENOUS LINE OF THE CARTRIDGE DURING A HOME HEMODIALYSIS TREATMENT ON (B)(6) 2023. ADDITIONAL INFORMATION WAS RECEIVED ON 24 FEB 2023 FROM THE HOME THERAPY NURSE (HTN) WHO STATED THE PATIENT DID NOT EXPERIENCE ANY SYMPTOMS, AND GAVE NO INDICATION OF MEDICAL INTERVENTION BEING REQUIRED.

  Patient problems: Hemorrhage/Blood Loss/Bleeding

  MAUDE report 16497266 ↗