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 Code	Cardiac Arrest (1762)
Date of Event	07/05/2023
Type of Reportable Event	Malfunction
Event or Problem Description
It was reported an automated peritoneal dialysis (pd) patient experienced cardiac arrest while connected to a homechoice claria device.The nurse reported the caregiver called emergency medical services and the patient was ¿emergently disconnected¿ for transport to hospital.Subsequently, the patient passed away.The cause of death was reported as cardiac arrest.It was reported an autopsy is being conducted and awaiting results.The nurse reported this was the first treatment since being discharged from the hospital for another indication.The treatment was reviewed by the pd nurse, and it was noted the patient¿s initial drain was only 48 ml.The nurse reported they were unsure if the hospital discharged the patient with fluid or not.There were no issues reported with the device and no alarms were generated.The device was operational, and a swap was not necessary.No additional information is available.
Additional Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
The device was not returned for evaluation; therefore, a sample analysis could not be completed.A device history review revealed no issues that could have caused or contributed to the reported issue.Review of the sharesource log data was performed, and review of the most recent treatment(s) revealed no excessive fill or drain volumes compared to the clinician programming.There was no indication of an iipv event or evidence of a device malfunction associated with the reported issue.The reported condition was not verified.Should additional relevant information become available, a supplemental report will be submitted.
Additional Manufacturer Narrative
H10: as previously reported, review of the sharesource log data was performed, and review of the most recent treatment(s) revealed no excessive fill or drain volumes compared to the clinician programming.There was no indication of an iipv event or evidence of a device malfunction associated with the reported issue.The reported condition was not verified.Based on additional information received, the homechoice claria was determined not to be a factor in the reported adverse event.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 60073 ; 2242702068
• MDR Report Key: 17443478
• Report Number: 1416980-2023-03881
• Device Sequence Number: 2735486
• Product Code: FKX
• UDI-Device Identifier: 00085412676463
• UDI-Public: (01)00085412676463
• Combination Product (Y/N): N
• Initial Reporter State: TX
• 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: Health Professional,Company Representative
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date (Section B): 03/05/2024

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
• Device Catalogue Number: 5C6M40
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/07/2023
• Supplement Date Received by Manufacturer: 08/10/2023; 03/05/2024
• Initial Report FDA Received Date: 08/02/2023
• Supplement Report FDA Received Date: 08/24/2023; 03/05/2024
• 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: Reuse
• Patient Sequence Number: 1
• Concomitant Medical Products and Therapy/Usage Dates: DIANEAL 1.5%,; DIANEAL 2.5%; DIANEAL 4.25%
• Outcome Attributed to Adverse Event: Death
• Patient Age: 70 YR
• Patient Sex: Male
• Patient Weight: 82 KG