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

Catalog Number 5C4471R

Device Problem Insufficient Information (3190)

Patient Problems Death (1802); Myocardial Infarction (1969); Heart Failure (2206)

Event Date 03/23/2014

Event Type  Death  

Event Description

It was reported that a peritoneal dialysis (pd) patient (pt) who performed therapy with a homechoice device (hc) passed away.The cause of this death was reported to be cardiac failure.Four days prior to death, the pt was hospitalized for a myocardial infarction.It was unknown if the pt was on the home choice device at the time of death.An autopsy was not performed.Additional information was requested but was not available.

Manufacturer Narrative

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

Manufacturer Narrative

(b)(4).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 event.The product analysis lab (pal) evaluated the device and no failures or malfunctions were identified that could have caused or contributed to the patient passing away.The device was determined to meet electrical performance specification requirements per return instrument test/ evaluation (rite) testing.The device failed the homechoice rite functional testing, however, it was determined that the failure was unrelated to the reported event.An internal and external inspection was performed and found no issues.An evaluation of the device pneumatic system revealed no leaks and all pressures were correct & stable.The device also passed seal, purge & wet disposable integrity tests.A short simulated therapy was performed successfully.Review of the device service history revealed no issues that could have caused or contributed to the home patient passing away.Upon conclusion of the investigation, no abnormalities or failures were identified that could have caused or contributed to the 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: 3812056
• MDR Text Key: 4369414
• Report Number: 1416980-2014-15556
• 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: 04/24/2014

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: 5C4471R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/19/2014
• Initial Date FDA Received: 05/15/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/14/2014
• 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 PD-4 1.5% AND 2.5% AMBUFLEX
• Patient Outcome(s): Death; Hospitalization
• Patient Age: 67 YR