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

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

Patient Problem Heart Failure (2206)

Event Date 08/04/2014

Event Type  Death  

Event Description

It was reported that a patient passed away coincident with peritoneal dialysis (pd) therapy.The patient was hospitalized approximately 2 months prior to passing away for an unrelated indication.During the hospitalization, the patient was using the facility homechoice (hc) device for pd therapy.The patient was treated with unspecified stent placement during the hospitalization.Additional treatment during hospitalization was not reported.Three weeks before passing away (in the month prior to death), the patient discontinued pd therapy.It was reported that the patient did not have peritonitis during the hospitalization.Pd therapy remained stopped for 1 week and then was resumed using the facility hc device.Pd therapy was performed for approximately 2 weeks before the patient passed away.Pd therapy was ongoing prior to death, but it was unknown if therapy with a baxter device and/or baxter pd solution(s) was being performed at the time of death.The cause of death was reported as cardiac failure.It was not reported if an autopsy was performed.Additional information was requested, but is not available.

Manufacturer Narrative

(b)(4).Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

(b)(4).The device was not returned and the serial number of the device was unknown; therefore, a device analysis, service history review, and device history review could not be completed.As a result, the direct cause of the reported event could not be determined.Should additional relevant information become available, a supplemental report 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: 4047893
• MDR Text Key: 4732814
• Report Number: 1416980-2014-28838
• 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: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 08/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/29/2014
• 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: 09/02/2014
• 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 2.5% SINGLEBAG
• Patient Outcome(s): Death; Other
• Patient Age: 83 YR