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

Catalog Number 5C4471R

Device Problem Insufficient Information (3190)

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

Event Date 02/26/2014

Event Type  Death  

Event Description

This is a report of a patient death coincident with peritoneal dialysis (pd) therapy on the homechoice (hc).It is unknown 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).The device has been received by baxter, but the evaluation has not yet been completed.A follow-up report will be submitted upon completion of the evaluation or if any additional relevant information is received.

Manufacturer Narrative

(b)(4).The device was manufactured in 1995.The device was returned for evaluation.A review of the device logs revealed no system errors, anomalies, hardware device failures or increased intraperitoneal volume (iipv) events that could have caused or contributed to the reported difficulty.The product analysis lab (pal) evaluated the device and no failure or malfunction were identified that could have caused or contributed to the home patient passing away.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.An internal and external inspection was performed and found no issues.The cycler remote toolbox (crt) was used to pressurize the device pneumatic system and all pressures were correct and stable.A short simulated therapy was performed and completed successfully.Review of the device service history and device history record 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
• 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: 3696592
• MDR Text Key: 4291214
• Report Number: 1416980-2014-09727
• 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,Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 02/27/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/24/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: 5C4471R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 03/21/2014
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/26/2014
• 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 PD2 1.5% AND 2.5% SOLUTIONS
• Patient Outcome(s): Death
• Patient Age: 67 YR