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

Device Problems Contamination (1120); Improper or Incorrect Procedure or Method (2017)

Patient Problems Bacterial Infection (1735); Peritonitis (2252)

Event Type  Death  

Event Description

It was reported that a patient experienced a breach in aseptic technique during peritoneal dialysis therapy, which resulted in the development of bacterial peritonitis.The breach in aseptic technique was further described as touch contamination.It was reported that the patient was not recovering from the peritonitis event and was diagnosed with recurring peritonitis.The patient was hospitalized for the event and treated with unspecified antibiotics (dose, route and frequency not reported).At the time of this report the patient remained hospitalized and was reported to be recovering from the peritonitis.It was unknown if the patient was retrained on aseptic technique.It was reported that pd therapy was discontinued and in-center hemodialysis was initiated.Additional information was requested but is not available.

Manufacturer Narrative

(b)(4).The patient was reported to have acquired peritonitis on an unknown date in (b)(6) 2014.This is a report of a patient who experienced a break in aseptic technique resulting in peritonitis.Per baxter labeling, users are instructed to use aseptic technique when performing peritoneal dialysis therapy.A formal review of the label for the product family will be conducted.Should additional relevant information become available, a follow-up report will be submitted.

Manufacturer Narrative

(b)(4).While hospitalized for the peritonitis, the patient experienced an acute mi (myocardial infarction) and passed away.The cause of death was an acute mi.It was unknown if an autopsy was performed.The patient's peritoneal dialysis therapy was ongoing until the patient's death.It was unknown if the patient was connected to a homechoice device at the time of death.Additional information was not available.Should additional relevant information become available, a follow-up 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: 3929762
• MDR Text Key: 4584756
• Report Number: 1416980-2014-22342
• 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: Consumer,Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 06/18/2014

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: 07/25/2014
• Initial Date FDA Received: 07/11/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/22/2014
• 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 AMBUFLEX AND EXTRANEAL
• Patient Outcome(s): Death; Hospitalization; Required Intervention