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 Problem Heart Failure (2206)

Event Date 07/31/2014

Event Type  Death  

Event Description

It was reported that a patient passed away coincident with peritoneal dialysis (pd) therapy.The patient was hospitalized prior to and at the time of death.The patient was admitted having trouble breathing and feeling sick.Pd therapy was ongoing prior to death, but therapy with a homechoice (hc) device and/or baxter pd solution(s) was not being performed at the time of death.Treatment provided during the hospitalization was not specified.The cause of death was heart failure and it was not reported if an autopsy was performed.Additional information was requested, but is not available.

Manufacturer Narrative

(b)(4).A review of the device history record found that the device was no longer in its original manufactured condition and there were no issues during its manufacture that could be related to the reported condition.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

(b)(4).The customer reported that the patient passed away.The device was returned to baxter healthcare for further investigation.A review of the event history log revealed no alarm or iipv event that could have caused or contributed to the reported problem.Visual inspection found no physical damage.The power on self-test was successfully completed.The one hour therapy was completed without error or alarm.The results of the sample analysis revealed no non-conforming product that could have caused or contributed to the reported problem.A review of the device history revealed no manufacturing 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 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: 4036945
• MDR Text Key: 4799492
• Report Number: 1416980-2014-28132
• Device Sequence Number: 1
• Product Code: FKX
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K102936
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 08/01/2014

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: 5C8310R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 09/10/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 09/30/2014
• Initial Date FDA Received: 08/26/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/27/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 02/13/2009
• 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% AND 2.5% ULTRABAG,; DIANEAL 1.5% AND 2.5% AMBUFLEX, EXTRANEAL 7.5%,
• Patient Outcome(s): Death; Hospitalization
• Patient Age: 86 YR
• Patient Weight: 86