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

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

Patient Problem Heart Failure (2206)

Event Date 08/08/2014

Event Type  Death  

Event Description

It was reported that a patient passed away due to heart failure coincident with automated peritoneal dialysis (apd) therapy.Five days prior to death, the patient was hospitalized for another indication.It was reported that apd therapy was ongoing until the time of death and that the patient was connected to the homechoice (hc) device at the time of death.The cause of death was reported to be heart failure.Treatment was not reported.It was not reported if an autopsy was performed.No additional information is available at this time.

Manufacturer Narrative

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

Manufacturer Narrative

(b)(4).The device was not returned to baxter healthcare for further investigation.Should additional relevant information become available, a supplemental 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: 4090593
• MDR Text Key: 4743840
• Report Number: 1416980-2014-31343
• Device Sequence Number: 1
• Product Code: FKX
• Combination Product (y/n): N
• Reporter Country Code: UK
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 08/21/2014

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
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 10/07/2014
• Initial Date FDA Received: 09/15/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/31/2014
• 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: PHYSIONEAL
• Patient Outcome(s): Death
• Patient Age: 59 YR