MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION HOMECHOICE CLARIA; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Health Effect - Clinical Code	Stacking Breaths (1593)
Date of Event	04/15/2024
Type of Reportable Event	Serious Injury
Event or Problem Description
I am on peritoneal dialysis and needed a valve replacement for aortic stenosis.The instruction for dialysis machine a baxter homechoice claira and the package inserts for the dilysate do not describe most of the serious side effects of the treatment including serious reduction in life expectancy, death and heart disease, which have been know for decades.It does explain that life expectancy is 3 times as long with a transplant, and that in many cases life expectancy without dialysis is similar to life expectancy with dialysis but with a much better quality of life.In the package inserts there is no disclosure or description of all the complications of dialysis which are many and quite serious.I had serious shortness of breath from the aortic stenosis, which required a valve replacement this was not disclosed, no was the fact that dialysis causes serious memory problem, fatigue heart disease, nor the complications listed below.Dialysis, while crucial for patients with kidney failure, can lead to various complications: 1.Cardiovascular issues: hypotension (low blood pressure), hypertension (high blood pressure), arrhythmias (irregular heartbeat), pericarditis (inflammation of the heart lining).2.Access-related problems: infection at the access site, clotting of the fistula or graft, aneurysm formation, stenosis (narrowing) of blood vessels.3.Electrolyte imbalances: hyperkalemia (high potassium levels), hypocalcemia (low calcium levels), hyperphosphatemia (high phosphate levels).4.Anemia: due to decreased erythropoietin production, iron deficiency.5.Bone and mineral disorders: renal osteodystrophy, increased risk of fractures.6.Infections: bloodstream infections (sepsis), peritonitis (in peritoneal dialysis).7.Dialysis disequilibrium syndrome: neurological symptoms due to rapid fluid and solute shifts.8.Amyloidosis: accumulation of beta-2 microglobulin, leading to joint pain and stiffness.9.Malnutrition: protein loss during dialysis, decreased appetite.10.Psychological issues: depression, anxiety, decreased quality of life.11.Dialyzer reactions: allergic reactions to dialyzer materials.12.Bleeding tendencies: due to use of anticoagulants during hemodialysis.13.Muscle cramps: particularly during fluid removal in hemodialysis.14.Itching (pruritus): often due to mineral imbalances or dry skin.15.Sleep disorders: insomnia, sleep apnea.16.Decreased cognitive function: "dialysis dementia" (rare with modern techniques).17.Fluid overload: edema, shortness of breath.18.Gastrointestinal issues: nausea and vomiting, constipation or diarrhea.The lack of disclosure of the serous risks of dialysis is egregious and long standing.

• Brand Name: HOMECHOICE CLARIA
• Common Device Name: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION
• MDR Report Key: 20248079
• Report Number: MW5159705
• Device Sequence Number: 8931497
• Product Code: FKX
• Combination Product (Y/N): N
• Initial Reporter State: IL
• Initial Reporter Country: US
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Voluntary
• Initial Reporter Occupation: Patient
• Type of Report: Initial
• Report Date (Section B): 09/15/2024

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Operator of Device: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Initial Date Received by Manufacturer: Not provided
• Initial Report FDA Received Date: 09/17/2024
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Hospitalization; Disability; Required Intervention; Life Threatening
• Patient Age: 74 YR
• Patient Sex: Male
• Patient Weight: 84 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White