MAUDE Adverse Event Report: BAXTER HEALTHCARE - LARGO HOMECHOICE PRO; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Catalog Number 5C8310R

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

Patient Problems Death (1802); Heart Failure (2206)

Event Date 06/23/2014

Event Type  Death  

Manufacturer Narrative

(b)(4).Additional information: it was reported that the home patient was performing only continuous ambulatory peritoneal dialysis (capd) therapy, using baxter disposable products only.The death certificate listed the cause of death as acute myocardial infarction, coronary artery disease, and diabetes mellitus.On an unknown date prior to death, the patient had discontinued apd and was only performing capd with dianeal solutions.On an unknown date, the patient went into the hospital for an unknown surgery on their toes and to ¿clean out an artery in their leg¿.The patient died while in the hospital during the surgery.Pd therapy had been ongoing up until the time of the hospitalization.The patient was not performing therapy on the homechoice nor were they performing therapy with any baxter solution at the time of death.It was unknown if an autopsy was done.Upon further investigation, it was determined that baxter devices and disposables are not suspect products for this event.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

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

Event Description

This is a report of a patient death coincident with peritoneal dialysis (pd) therapy on the homechoice (hc).It was not reported if the patient was hospitalized prior to death.The cause of death was reported to be 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.

• Brand Name: HOMECHOICE PRO
• Type of Device: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): BAXTER HEALTHCARE - LARGO; 7511 114th ave. north; largo FL 33773
• Manufacturer (Section G): BAXTER HEALTHCARE - LARGO; 7511 114th ave. north; largo FL 33773
• Manufacturer Contact: christina arnt ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242703198
• MDR Report Key: 3939892
• MDR Text Key: 12278425
• Report Number: 1416980-2014-22934
• Device Sequence Number: 1
• Product Code: FKX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102936
• 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,Followup
• Report Date: 06/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/16/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 5C8310R
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 09/26/2014
• 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 2.5% AMBUFLEX
• Patient Outcome(s): Death
• Patient Age: 71 YR