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

Catalog Number 5C4471R

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

Patient Problems Death (1802); Unspecified Infection (1930); Renal Disease, End Stage (2039); Heart Failure (2206)

Event Date 04/24/2014

Event Type  Death  

Event Description

It was reported that a peritoneal dialysis (pd) patient (pt) who performed therapy with a homechoice device (hc) passed away.The cause of death was reported to be cardiac failure, diabetes, renal disease, and an infection related to an amputation.It was unknown if therapy was ongoing until the time of death.It was not reported if an autopsy was performed.Additional information was requested but was not available.

Manufacturer Narrative

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

Manufacturer Narrative

(b)(4).The device was returned to baxter healthcare for further investigation.A review of the event history log revealed no failure, malfunction or increased intraperitoneal volume (iipv) events that could have caused or contributed to the reported problem.Internal and external visual inspections were performed and revealed no problems.The device passed both the electrical and functional testing.Analysis of the device pneumatic system revealed no leaks and all pressures were correct and stable.The device passed seal, purge & wet disposable integrity tests.A short simulated therapy was performed on the device successfully.The results of the sample analysis revealed no failure or malfunction were identified that could have caused or contributed to the patient passing away.A review of the service history revealed no previous service events that would cause or contribute to the reported problem.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: HOMECHOICE
• 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: 3830318
• MDR Text Key: 4497148
• Report Number: 1416980-2014-16752
• 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: Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/28/2014

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
• Device Catalogue Number: 5C4471R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 06/09/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 07/14/2014
• Initial Date FDA Received: 05/23/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/08/2014
• 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% ULTRABAG, DIANEAL 1.5% AMBUFLEX
• Patient Outcome(s): Death
• Patient Age: 59 YR