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

Catalog Number 5C8310R

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

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

Event Date 03/27/2014

Event Type  Death  

Event Description

This is a report of a patient death coincident with peritoneal dialysis (pd) therapy on the homechoice (hc).The patient was hospitalized prior to death.The cause of death was reported to be due to a ¿massive heart attack¿.It was reported pd therapy was ongoing at the hospital; however, it is unknown if the patient was on the hc device at the time of death.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 returned to baxter healthcare for further investigation.A review of the event history log revealed no failure, malfunction or iipv (increased intraperitoneal volume) events that could have caused or contributed to the reported problem.The sample analysis was not performed because the serial number of the device was incorrect when the device was received and routed for servicing.A review of the service history revealed no previous service events that would cause or contribute to the reported problem.There was no failure, malfunction or iipv event identified that could have caused or contributed to the reported issue of patient passing away.The cause could not be determined.Should additional relevant information become available, a follow-up will be submitted.

• Brand Name: HOMECHOICE PRO
• 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: 3765025
• MDR Text Key: 18296837
• Report Number: 1416980-2014-13017
• 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: 03/28/2014

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: 04/11/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/10/2014
• Initial Date FDA Received: 04/22/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/02/2014
• 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 2.5% SOLUTION
• Patient Outcome(s): Death
• Patient Age: 70 YR