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

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

Patient Problems Dyspnea (1816); Heart Failure (2206); Abdominal Distention (2601)

Event Date 07/24/2014

Event Type  Death  

Event Description

This is a report of a patient death coincident with peritoneal dialysis (pd) therapy on the homechoice (hc).The patient was hospitalized seventeen days prior to death for multiple indications.It was reported pd therapy was ongoing at the time of death; however, the patient was not performing therapy with the hc device at the time of death.The caregiver reported that during the hospitalization, the patient developed fluid overload, abdominal distention, bloating and shortness of breath.The cause of death was reported to be cardiac failure.It was reported an autopsy was not performed.A death certificate was not available.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 sample was not returned for evaluation and the serial number is unknown, therefore a device analysis could not be performed.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: 4018322
• MDR Text Key: 4849949
• Report Number: 1416980-2014-27079
• 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: 07/24/2014

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: 10/03/2014
• Initial Date FDA Received: 08/18/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/28/2014
• 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 PD4 1.5% AND 2.5% AMBUFLEX
• Patient Outcome(s): Death
• Patient Age: 66 YR