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

Catalog Number 5C8310R

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

Patient Problem Heart Failure (2206)

Event Date 11/27/2014

Event Type  Death  

Event Description

It was reported that a peritoneal dialysis (pd) patient who performed therapy with a homechoice device (hc) passed away.The patient was not hospitalized prior to death as he passed away at home.The cause of death was reported to be cardiac failure.The patient was not connected to the hc device at the time of death.The pdrn stated that an autopsy was not performed and a death certificate was not available.No additional information is 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 evaluation.The service history review revealed no previous service events that would cause or contribute to the reported problem.The event history log review revealed no alarm or iipv event that could have caused or contributed to the reported problem.A visual inspection was performed with no abnormalities noted.The device passed both the homechoice rite (return instrument test/evaluation) electrical test and the homechoice rite functional test and was determined to meet performance specification requirements per rite testing.A short simulated therapy was performed and completed successfully.The sample analysis revealed no non-conforming product that could have caused or contributed to the reported problem.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: HOME CHOICE 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: kinga almasan ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 4359015
• MDR Text Key: 5119815
• Report Number: 1416980-2014-47326
• 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,Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 12/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/23/2014
• 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?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/09/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/19/2015
• 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% SINGLEBAG SOLUTIONS
• Patient Outcome(s): Death
• Patient Age: 58 YR