MAUDE Adverse Event Report: BAXTER HEALTHCARE - SINGAPORE 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 11/03/2014

Event Type  Death  

Event Description

It was reported that a peritoneal dialysis patient passed away.The cause of death was reported to be cardiac failure.It was not reported if dianeal therapy was ongoing prior to death.It was not reported if an autopsy was performed.No additional information is available.

Manufacturer Narrative

(b)(4).The device was returned and the evaluation is ongoing.Should additional relevant information become available, a follow-up will be submitted.

Manufacturer Narrative

(b)(4).The device was received and an evaluation was performed to investigate the reported event.The event history log review showed no keystrokes, programming, or use related events that indicated and/or contributed to the reported issue.Review of the service history revealed no issues that could have caused or contributed to the reported issue.The homechoice device passed returned instrument testing evaluation (rite) functional and electrical testing.Internal and external inspections were performed and found no issues.The pneumatic system was tested and all pressures were found to be correct and stable.A short simulated therapy was successfully performed.During evaluation, no failure, malfunction or increased intra-peritoneal volume (iipv) event was identified that could have caused or contributed to the event.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 - 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: 4290751
• MDR Text Key: 5191298
• Report Number: 1416980-2014-43421
• 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: 11/05/2014

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: 11/20/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 12/29/2014
• Initial Date FDA Received: 12/02/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/16/2015
• 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 1.5% AND 2.5% AMBUFLEX
• Patient Outcome(s): Death
• Patient Age: 64 YR
• Patient Weight: 100