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 03/31/2014

Event Type  Death  

Event Description

It was reported that a patient died coincident with peritoneal dialysis (pd) therapy.The nurse reported that the cause of death was cardiac failure.The patient was not hospitalized prior to the death.It was unknown if an autopsy was performed.The pd therapy was reported to be ongoing until the time of death.Additional information was requested and was not available at this time.

Manufacturer Narrative

(b)(4).The device was received for analysis.The evaluation is anticipated and upon completion of the investigation, if additional relevant information is obtained, a follow-up mdr will be submitted.

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 increased intraperitoneal volume (iipv) events that could have caused or contributed to the reported problem.The results of the sample analysis revealed that the device was tested and passed both functional test and electrical testing.External and internal inspections were performed and revealed no problems.An analysis of the device pneumatic system was performed and revealed no leaks and all pressures were correct and stable.The device passed seal, purge and wet disposable integrity test and successfully completed a short simulated therapy.No failure or malfunction was identified that could have caused or contributed to the reported problem.A review of the service history revealed no previous service events that would cause or contribute to the reported problem.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: 3776980
• MDR Text Key: 4377768
• Report Number: 1416980-2014-13789
• 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: 04/03/2014

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: 04/21/2014
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 06/17/2014
• Initial Date FDA Received: 04/29/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 07/11/2014
• 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 2.5% PD4 AMBUFLEX AND EXTRANEAL
• Patient Outcome(s): Death
• Patient Age: 52 YR