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

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

Patient Problems Renal Failure (2041); Sepsis (2067); Heart Failure (2206)

Event Date 08/20/2014

Event Type  Death  

Event Description

It was reported that a patient passed away coincident with automated peritoneal dialysis (apd) therapy.The cause of death was reported to be due to renal failure, sepsis and cardiac failure.The cause of the sepsis event was unknown.It was reported that the patient had been hospitalized for an unknown indication and subsequently passed away.Treatment while hospitalized was unknown.It was reported that during hospitalization pd therapy was discontinued and the patient was placed on hemodialysis.It was unknown if an autopsy was performed.Additional information was requested but is not available.This is report 3 of 4 involved in this event.

Manufacturer Narrative

(b)(4).The reported product is an unknown baxter cassette.Should additional relevant information become available, a supplemental report will be submitted.This report involves the same patient as in (b)(4).

Manufacturer Narrative

(b)(4).The sample was not returned for evaluation and the lot 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 - MOUNTAIN HOME; 1900 n highway 201; mountain home AR 72653
• Manufacturer (Section G): BAXTER HEALTHCARE - MOUNTAIN HOME; 1900 n highway 201; mountain home AR 72653
• Manufacturer Contact: christina arnt ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242703198
• MDR Report Key: 4090253
• MDR Text Key: 4743398
• Report Number: 1416980-2014-31315
• 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,Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 08/21/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/15/2014
• 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: 10/09/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: TRANSFER SET, TITANIUM ADAPTER, MINICAP,; DIANEAL PD4 4.25% AMBUFLEX,; DIANEAL PD4 2.5% AMBUFLEX, HOMECHOICE
• Patient Outcome(s): Death; Hospitalization
• Patient Age: 47 YR