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 01/08/2014

Event Type  Death  

Event Description

This is a report of a patient death coincident with peritoneal dialysis (pd) therapy on the homechoice.It was not reported if the patient was hospitalized prior to death.The cause of death was reported as cardiac failure.It was not reported if an autopsy was performed.Additional information was requested, but is not available.

Manufacturer Narrative

(b)(4).A request for the return of the device has been made.Should the device be received by baxter for evaluation, a follow-up report will be filed upon completion of an evaluation or if any additional information becomes available.

Manufacturer Narrative

(b)(4).Evaluation summary: the device was received for evaluation.Visual inspection, electrical testing, and functional testing were performed and passed with relationship to the reported condition.A simulated patient therapy test, accuracy test, and temperature test were performed and passed.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 event.A device history review was performed and found that the device had previously failed pneumatic testing.The device was retested and passed subsequent testing.A service history record review was performed and revealed no issues that could have caused or contributed to the reported condition.No device malfunction or iipv was confirmed related to the reported condition.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: 3604332
• MDR Text Key: 4157462
• Report Number: 1416980-2014-03264
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/09/2014

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: 01/28/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 03/05/2014
• Initial Date FDA Received: 02/03/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 03/28/2014
• 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 LOW CALCIUM 1.5% SOLUTION; DIANEAL LOW CALCIUM 2.5% SOLUTION
• Patient Outcome(s): Death
• Patient Age: 59 YR