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

Catalog Number 5C4471R

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Cardiac Arrest (1762); Heart Failure (2206)

Event Type  Death  

Event Description

It was reported that a patient died coincident with peritoneal dialysis therapy.The cause of death was cardiac arrest and cardiac failure.The patient was hospitalized for the cardiac arrest event "a couple days prior to death" and died at the hospital.Treatment during the hospitalization was not reported.Peritoneal dialysis therapy was ongoing until hospitalization.It was unknown if peritoneal dialysis therapy was ongoing during hospitalization.The patient was not performing automated peritoneal dialysis therapy at the time of death.It was not reported if an autopsy was performed.No additional information is available.

Manufacturer Narrative

(b)(4).Date of the event: the exact occurrence date of the cardiac arrest and hospitalization was not provided; the events were reported to have taken place ¿a couple of days prior to death¿.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

(b)(4).Additional information: 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 event.A service history review revealed no indication that the parts replaced during servicing caused or contributed to the reported event.Internal and external inspection was performed and no issues were noted.The homechoice device received a returned instrument testing evaluation (rite).This evaluation included functional and electrical testing of the device.The device was determined to meet functional and electrical performance specification requirements per rite testing.All pressures were found to be correct and stable.The device passed all seal, purge and integrity testing.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.The cause of the reported event of death could not be determined.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: kinga almasan ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 4520658
• MDR Text Key: 5404698
• Report Number: 1416980-2015-05914
• 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: 01/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/17/2015
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Other
• Device Catalogue Number: 5C4471R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 02/17/2015
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 03/05/2015
• 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 2.5% PD4 AMBUFLEX, EXTRANEAL; DIANEAL 1.5% PD4 AMBUFLEX,
• Patient Outcome(s): Death; Hospitalization
• Patient Weight: 66