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

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

Patient Problems Pulmonary Edema (2020); Heart Failure (2206)

Event Date 08/21/2014

Event Type  Death  

Manufacturer Narrative

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

Event Description

It was reported that a peritoneal dialysis (pd) patient who performed therapy with a homechoice device (hc) passed away.The cause of death was pulmonary edema and heart failure.It was not reported if pd therapy was ongoing until the time of death.It was not reported if an autopsy was performed.No additional information is available.

Manufacturer Narrative

(b)(4).Should additional relevant information become available, a follow-up will be submitted.

• Type of Device: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION
• Manufacturer (Section G): BAXTER HEALTHCARE CORPORATION
• Manufacturer Contact: christina arnt ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242703198
• MDR Report Key: 4102834
• MDR Text Key: 15667570
• Report Number: 1416980-2014-32213
• Device Sequence Number: 1
• Product Code: FKX
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/25/2014

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
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 10/09/2014
• Initial Date FDA Received: 09/19/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 11/07/2014
• 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 1.5% AND 2.5% AMBUFLEX
• Patient Outcome(s): Death
• Patient Age: 71 YR