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

Catalog Number 5C8310

Device Problem Insufficient Information (3190)

Patient Problems Death (1802); Heart Failure (2206); Multiple Organ Failure (3261)

Event Date 01/08/2014

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 disease.On an unknown date in the month prior to death, the pt was hospitalized for another indication.On an unreported date in the same month as being admitted, the pt was discharged from the hospital and went home on hospice care.Subsequently, the pt died.The cause of death was reported to be due to cardiac disease.The cause of death was further described as possibly due to multi-system organ failure, however, this was not confirmed.Pd therapy was ongoing until the time of death.The pt was not connected to the hc at the time of death.It was unknown if an autopsy was performed.Additional information was requested but is not available.

Manufacturer Narrative

(b)(4).Should additional relevant information become available, a follow-up medwatch will be submitted.

Manufacturer Narrative

(b)(4).A review of the device history revealed no issues that could have caused or contributed to the patient passing away.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

(b)(4).The serial number ((b)(4)) and catalog number (5c8310r) that were previously reported were incorrect and the actual sn and catalog number associated with this patient were sn (b)(4) and catalog number 5c8310.As the device was not linked to the reported death until after the device had been serviced, a complete device analysis could not be completed to investigate the reported death.However, a review of the device logs revealed no system errors, anomalies, hardware device failures or intraperitoneal volume iipv events that could have caused or contributed to the reported difficulty.The device passed both the homechoice rite (return instrument test/evaluation) electrical test and the homechoice rite functional test and was determined to meet performance specification requirements per rite testing.Review of the service history revealed no issues that could have caused or contributed to the home patient passing away.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 FL 33773 257; SN 33773 2573
• Manufacturer (Section G): BAXTER HEALTHCARE - SINGAPORE; 2 woodlands industrial park; singapore FL 33773 257; SN 33773 2573
• Manufacturer Contact: christina arnt ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242703198
• MDR Report Key: 3606473
• MDR Text Key: 4067210
• Report Number: 1416980-2014-03401
• 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,Followup
• Report Date: 01/10/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/04/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 5C8310
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 01/22/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 05/08/2014
• 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% ULTRABAG; DIANEAL PD4 2.5% AMBUFLEX
• Patient Outcome(s): Death
• Patient Age: 62 YR
• Patient Weight: 75