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

Catalog Number	5C6M40
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Codes	Dyspnea (1816); Abdominal Distention (2601)
Date of Event	02/23/2022
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
The device has been received and the evaluation is in progress.Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
It was reported an automated peritoneal dialysis patient felt bloated and had difficulty breathing during dwell 1 of 4.The patient was connected to the homechoice claria device at the time of the events.The therapy volume was14500 ml, fill volume was 3000 ml, the last fill volume was 2500ml and the initial drain alarm was 0.Renal therapy services (rts) instructed the caregiver to immediately press stop and arrow down to perform a manual drain.Draining relieved symptoms.The drain volume was 5782 ml.Rts had the caregiver press stop and arrow down to bypass, after pressing enter the device displayed drain 1 of 4.Rts initiated a swap of the device and continuous ambulatory peritoneal dialysis was discussed.There was no medical intervention associated with this event.No additional information is available.
Additional Manufacturer Narrative
The device was received for evaluation.The homechoice claria device received returned instrument testing evaluation (rite) functional testing.The device was determined to meet functional performance specification requirements per rite testing.A service history review revealed no indication that the parts replaced during servicing caused or contributed to the reported event.No device failure or malfunction was identified that could have caused or contributed to the reported event.The event history log review showed the programmed i-drain (0ml) was set too low for the most recent therapies.Per the homechoice claria clinician guide, the programmed minimum initial drain should be set to at least 70% of the expected peritoneal volume.The device logs showed the programmed last fill was 2,500ml.Based on the device log analysis, the direct cause of the reported event was determined to be the programmed i-drain alarm being set too low.The homechoice and homechoice pro apd systems patient at-home guide warns that ¿setting the i-drain alarm volume too low or off can result in an incomplete initial drain followed by a full fill.This can result in an increased intraperitoneal volume (iipv) situation.¿ should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: HOMECHOICE CLARIA
• Common Device Name: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION; deerfield IL
• Manufacturer (Section G): BAXTER HEALTHCARE - SINGAPORE; 2 woodlands industrial park d; singapore 73875 0; SN 738750
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL ; 2242702068
• MDR Report Key: 13791325
• Report Number: 1416980-2022-01111
• Device Sequence Number: 1688806
• Product Code: FKX
• UDI-Device Identifier: 00085412676463
• UDI-Public: (01)00085412676463
• Combination Product (Y/N): N
• Initial Reporter State: FL
• Initial Reporter Country: US
• PMA/510(K) Number: K201867
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): N
• Reporter Type: Manufacturer
• Report Source: Consumer,Company Representative
• Initial Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date (Section B): 04/11/2022

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?: No
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 5C6M40
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/25/2022
• Is the Reporter a Health Professional?: No
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/23/2022
• Supplement Date Received by Manufacturer: 03/17/2022
• Initial Report FDA Received Date: 03/17/2022
• Supplement Report FDA Received Date: 04/11/2022
• Was Device Evaluated by Manufacturer? (Y/N): Yes
• Is the Device Labeled for Single Use? (Y/N): No
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown