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

Catalog Number 5C4471R

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

Patient Problem Heart Failure (2206)

Event Date 10/04/2014

Event Type  Death  

Event Description

It was reported that a patient passed away due to cardiac failure coincident with automated peritoneal dialysis (apd) therapy.It was not reported whether the patient was hospitalized prior to death.It was not reported whether the patient was connected to the homechoice (hc) at the time of death or if apd therapy was ongoing until the time of death.It was not reported if an autopsy was performed.No additional information is available at this time.

Manufacturer Narrative

Complaint no: (b)(4).The device was received for analysis and an evaluation has begun but has not yet been completed.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

(b)(4).The device was returned and an evaluation was performed to investigate the reported death.A review of the service history revealed no indication that the parts replaced during servicing caused or contributed to the reported event.The event history log was reviewed and revealed no programming, malfunction, or iipv events that could have caused or contributed to the patient passing away.The device was determined to meet functional and electrical performance specification requirements per rite (returned instrument test evaluation) testing.A simulated therapy was completed with no issues noted and testing of the pneumatic system revealed all pressures to be correct and stable.An internal and external visual inspection revealed no problems related to the reported event.Upon conclusion of the investigation, no malfunction, abnormalities or iipv events were identified that could have caused or contributed to the patient passing away.Should additional relevant information become available, a follow-up report will be submitted.

• 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: 4291464
• MDR Text Key: 5271585
• Report Number: 1416980-2014-43474
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 11/06/2014

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: 11/24/2014
• Is the Reporter a Health Professional?: No
• Initial Date Manufacturer Received: 12/29/2014
• Initial Date FDA Received: 12/02/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 01/23/2015
• 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 PD4, 1.5% AMBUFLEX
• Patient Outcome(s): Death
• Patient Age: 86 YR