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

Catalog Number 5C8310R

Device Problem Insufficient Information (3190)

Patient Problems Death (1802); Dyspnea (1816); Pulmonary Edema (2020); Heart Failure (2206)

Event Date 06/07/2014

Event Type  Death  

Event Description

This is a report of a patient who passed away coincident with peritoneal dialysis (pd) therapy.The cause of death was reported to be due to a heart failure.It was reported that the patient was hospitalized for difficulty breathing and fluid in the lungs.The patient was treated with lasix (dose, route and frequency not specified) and tylenol (dose, route and frequency not specified) for the event.Seven days after hospitalization the patient passed away.Pd therapy was ongoing at the time of death.It was unknown if an autopsy was performed.No additional information is available at this time.

Manufacturer Narrative

(b)(4).Should additional relevant information become available, a supplemental report 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 iipv events that could have caused or contributed to the reported problem.The results of the sample analysis revealed the home choice device was evaluated and all functional tests were performed as per baxter¿s required procedures.A visual inspection found damaged door cover.The power on self-test was successfully completed.The one hour therapy was completed without error or alarm.A review of the device history revealed no nonconformities, failures, rework or deviations that would cause or contribute to the reported problem.There was no non-conforming product identified related 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: 3909126
• MDR Text Key: 4488302
• Report Number: 1416980-2014-21186
• Device Sequence Number: 1
• Product Code: FKX
• Combination Product (y/n): N
• PMA/PMN Number: K102936
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Company Representative
• Type of Report: Initial,Followup
• Report Date: 06/09/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/02/2014
• 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: 07/18/2014
• Date Manufacturer Received: 07/28/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 05/07/2008
• 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: EXTRANEAL; HEPARIN; DIANEAL 1.5%, 2.5%
• Patient Outcome(s): Death; Hospitalization; Required Intervention
• Patient Age: 85 YR