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

Catalog Number 5C8310R

Device Problem Insufficient Information (3190)

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

Event Date 12/18/2013

Event Type  Death  

Event Description

It was reported that a peritoneal dialysis (pd) patient (pt) who performed pd therapy with a homechoice (hc) device passed away due to cardiac failure.It was not reported if pd therapy was on-going until the time of death or if the pt was connected to the cycler at the time of death.Additional information was requested but is not available.

Manufacturer Narrative

Complaint no: cmplnt-(b)(4).Evaluation summary: the analysis lab received and evaluated the device.The device passed both the homechoice rite electrical test and the homechoice rite functional test and was determined to meet performance specification requirements per rite testing.No failure or malfunction was identified that could have caused or contributed to the home patient passing away.A review of the device logs revealed no system errors, anomalies, hardware device failures or iipv events that could have caused or contributed to the reported difficulty.Should additional relevant information become available, a follow-up will be submitted.

Manufacturer Narrative

(b)(4).Review of device history and service history revealed no failures/problems that was related to the patient's death and there was no indication that the parts replaced during servicing caused or contributed to the reported death.Upon conclusion of the investigation, the cause of the reported event could not be determined.Should additional relevant information become available, a follow-up report will be submitted.

• Brand Name: HOMECHOICE PRO
• Type of Device: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): BAXTER HEALTHCARE - SINGAPORE; 2 woodlands industrial park; singapore 2573 ; SN 2573
• Manufacturer (Section G): BAXTER HEALTHCARE - SINGAPORE; 2 woodlands industrial park; singapore 2573 ; SN 2573
• Manufacturer Contact: christina arnt ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242703198
• MDR Report Key: 3585788
• MDR Text Key: 4188335
• Report Number: 1416980-2014-02291
• 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
• Report Date: 12/27/2013

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/21/2014
• 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: 01/17/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 02/05/2014
• 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: 59 YR