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

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

Patient Problem Heart Failure (2206)

Event Date 03/28/2015

Event Type  Death  

Event Description

It was reported that a patient died coincident with automated peritoneal dialysis therapy.The cause of death was reported as cardiac failure.It was reported that the patient was hospitalized for over one month for an unreported indication prior to death and was hospitalized at the time of death.It was not reported if an autopsy was performed.Peritoneal dialysis therapy was ongoing up until the time of death with the patient using a facility provided cycler and it was not reported if the patient was connected to the baxter healthcare homechoice device or if the patient was performing therapy with baxter healthcare disposables and/or baxter healthcare solutions at the time of death.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 and the serial number is unknown; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

• Type of Device: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION
• Manufacturer (Section G): BAXTER HEALTHCARE CORPORATION
• Manufacturer Contact: kinga almasan ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 4728065
• MDR Text Key: 5749681
• Report Number: 1416980-2015-18919
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 04/03/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/24/2015
• 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?: No
• Date Manufacturer Received: 05/20/2015
• 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: EXTRANEAL; DIANEAL 1.5% AND 2.5% LOW CALCIUM SINGLEBAG
• Patient Outcome(s): Death
• Patient Age: 65 YR