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

Device Problems Obstruction of Flow (2423); Defective Device (2588); Human-Device Interface Problem (2949)

Patient Problem No Clinical Signs, Symptoms or Conditions (4582)

Event Type  Injury  

Event Description

I have a baxter homechoice claira cycler.As described earlier this a defective and poorly designed product.My dialysate prescription was changed adding a third bag of 7.5% extraneal dialysate that i am supposed to fill my peritoneal cavity for making an exchange at the beginning of the day after my nighttime exchanges have occurred.However often i need to do a final manual drain since as much as half, 800 ml of dialysate is left in my belly.However if the drain is incomplete for the night, the cycler fills my belly with the 7.5% solution which is now a mixture of extraneal and dextrose so i am not getting the right prescription.Further some of the dextrose solution get reabsorbed by the gut and can increase my blood glucose levels which is obviously a serious problem for diabetics like me.When i call davita my dialysis clinic they said they did not know what do and that there was no way to program the caller to pause so the patent could do a manual drain.The cycler has a provision for a final bag to be used during the day but is clear defective in this regard and should be recalled.

• Brand Name: BAXTER HOMECHOICE CLARIA
• Type of Device: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION
• MDR Report Key: 17135890
• MDR Text Key: 317328927
• Report Number: MW5118411
• Device Sequence Number: 1
• Product Code: FKX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Patient
• Type of Report: Initial

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/14/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: Yes
• Patient Sequence Number: 1
• Treatment: DEXTROSE ; EXTRANEAL
• Patient Outcome(s): Required Intervention
• Patient Age: 73 YR
• Patient Sex: Male
• Patient Weight: 82 KG
• Patient Ethnicity: Non Hispanic
• Patient Race: White