MAUDE Adverse Event Report: BAXTER HEALTHCARE - SINGAPORE HOMECHOICE PRO; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Catalog Number	5C8310
Medical Device Problem Code	Adverse Event Without Identified Device or Use Problem (2993)
Health Effect - Clinical Code	Death (1802)
Type of Reportable Event	Death
Additional Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
Event or Problem Description
An automated peritoneal dialysis patient passed away.The cause of death was not reported.It was not reported if the patient was hospitalized prior to death.It was not reported if an autopsy was performed.It was not reported if therapy was ongoing prior to death or if the patient was performing therapy at the time of death.No additional information is available.
Additional Manufacturer Narrative
The device was received for evaluation.The event history log review showed no keystrokes, programming, or use related events that indicated and/or contributed to the reported issue.Internal and external inspection was performed and no issues were noted.The homechoice device received a returned instrument testing evaluation (rite).This evaluation included functional and electrical testing of the device.The device was determined to meet functional and electrical performance specification requirements per rite testing.A device history review revealed no issues that could have caused or contributed to the reported issue.The cause of the condition could not be determined.No device failure or malfunction was identified that could have caused of contributed to the reported event; therefore, the homechoice pro is no longer considered suspect product in this event.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: HOMECHOICE PRO
• Common Device Name: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): BAXTER HEALTHCARE - SINGAPORE; singapore
• MDR Report Key: 7182173
• Report Number: 1416980-2018-00073
• Device Sequence Number: 10799044
• Product Code: FKX
• UDI-Device Identifier: 00085412079165
• UDI-Public: (01)00085412079165
• Combination Product (Y/N): N
• Initial Reporter State: AZ
• Initial Reporter Country: US
• PMA/510(K) Number: K102936
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Reporter Type: Manufacturer
• Report Source: company representative,health
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 02/22/2018

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Is this an Adverse Event Report?: Yes
• Operator of Device: Lay User/Patient
• Device Catalogue Number: 5C8310
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/23/2018
• Initial Date Received by Manufacturer: 12/22/2017
• Supplement Date Received by Manufacturer: 02/20/2018
• Initial Report FDA Received Date: 01/11/2018
• Supplement Report FDA Received Date: 02/22/2018
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Death