MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION; SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE

Device Problem Contamination (1120)

Patient Problems Death (1802); Sepsis (2067)

Event Date 06/20/2014

Event Type  Death  

Event Description

It was reported that a peritoneal dialysis (pd) patient acquired sepsis and later passed away.The cause of the sepsis was unknown.The patient was hospitalized prior to passing away.Treatment information was not reported.During hospitalization, the patient performed continuous ambulatory peritoneal dialysis therapy until the time of death.The cause of death was reported to be sepsis.It was unknown if an autopsy was performed.No further information was provided.Additional information was requested but is not available.

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 and the lot 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: SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION
• Manufacturer (Section G): BAXTER HEALTHCARE CORPORATION
• Manufacturer Contact: christina arnt ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242703198
• MDR Report Key: 3951002
• MDR Text Key: 4606722
• Report Number: 1416980-2014-23700
• Device Sequence Number: 1
• Product Code: KDJ
• Combination Product (y/n): N
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 06/27/2014

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: 10/01/2014
• Initial Date FDA Received: 07/22/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/27/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Unknown
• Patient Sequence Number: 1
• Treatment: DIANEAL 2.5% ULTRABAG; DIANEAL 2.5% AMBUFLEX; DIANEAL 1.5% AMBUFLEX; DIANEAL 1.5% ULTRABAG
• Patient Outcome(s): Death; Hospitalization
• Patient Age: 56 YR