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

Device Problem Insufficient Information (3190)

Patient Problems Cardiac Arrest (1762); Death (1802); Heart Failure (2206)

Event Date 07/07/2014

Event Type  Death  

Event Description

It was reported that a patient died coincident with peritoneal dialysis therapy.The cause of death was reported to be due to cardiac failure.The patient was hospitalized for an unrelated issue prior to death.The patient was not performing therapy at the time of death.On the same day as the death, the patient had a procedure to place a hemodialysis catheter.After the procedure, the patient had cardiac arrest and died.An autopsy was not performed.No additional information is available.

Manufacturer Narrative

(b)(4).Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

(b)(4).The device was not returned; therefore, a device analysis could not be completed.The cause of the reported event of death could not be determined.Should additional relevant information become available, a supplemental report will be submitted.

• Type of Device: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): BAXTER HEALTHCARE
• Manufacturer (Section G): BAXTER HEALTHCARE
• Manufacturer Contact: christina arnt ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242703198
• MDR Report Key: 3977753
• MDR Text Key: 4890474
• Report Number: 1416980-2014-25282
• Device Sequence Number: 1
• Product Code: FKX
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 07/11/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/04/2014
• 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
• Date Manufacturer Received: 10/03/2014
• 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% LOW CALCIUM SINGLEBAG; DIANEAL 1.5% LOW CALCIUM SINGLEBAG
• Patient Outcome(s): Death
• Patient Age: 56 YR