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

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Heart Failure (2206)

Event Date 08/28/2014

Event Type  Death  

Event Description

It was reported that a peritoneal dialysis (pd) patient who performed therapy with a homechoice passed away.The cause of death was reported to be heart failure.The cause of the heart failure was not reported.It was unknown whether dianeal therapy was ongoing until the time of death.Treatment was not reported.It was unknown if an autopsy was performed.No additional information is available.

Manufacturer Narrative

Complaint no: (b)(4).Should additional relevant information become available, a follow-up will be submitted.

Manufacturer Narrative

(b)(4).As the device was not returned and the serial number is unknown, a device analysis cannot be completed; therefore, the cause of the reported event was not determined.Should additional relevant information become available, a supplemental report will be submitted.

• Type of Device: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): BAXTER HEATHCARE CORPORATION
• Manufacturer (Section G): BAXTER HEALTHCARE CORPORATION
• Manufacturer Contact: christina arnt ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242703198
• MDR Report Key: 4117545
• MDR Text Key: 4702696
• Report Number: 1416980-2014-33114
• Device Sequence Number: 1
• Product Code: FKX
• Combination Product (y/n): N
• Reporter Country Code: PL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 09/01/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/25/2014
• 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
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 12/11/2014
• 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
• Patient Outcome(s): Death
• Patient Age: 74 YR