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

Device Problem Insufficient Information (3190)

Patient Problems Death (1802); Heart Failure (2206)

Event Date 12/16/2013

Event Type  Death  

Event Description

This is a report of a patient death coincident with peritoneal dialysis (pd) therapy on the homechoice.The cause of death was due to heart failure.It was not reported if an autopsy was performed.Additional information was requested, but is not available.

Manufacturer Narrative

(b)(4).If additional relevant information is received, a supplemental medwatch will be filed.

Manufacturer Narrative

(b)(4).The device was not returned , therefore, a device analysis cannot be completed.The cause of the reported issue is undetermined.Should additional relevant information become available, a follow-up will be submitted.

• Type of Device: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): BAXTER HEALTHCARE
• Manufacturer (Section G): BAXTER HEALTHCARE
• Manufacturer Contact: christina arnt ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242703198
• MDR Report Key: 3574925
• MDR Text Key: 4036522
• Report Number: 1416980-2014-01600
• Device Sequence Number: 1
• Product Code: FKX
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Company Representative
• Type of Report: Initial,Followup
• Report Date: 12/20/2013

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
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 01/27/2014
• Initial Date FDA Received: 01/14/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 02/18/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1
• Treatment: DIANEAL LOW CALCIUM 2.5% AND EXTRANEAL SOLUTIONS
• Patient Outcome(s): Death