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 Abdominal Pain (1685); Peritonitis (2252)

Event Date 05/29/2014

Event Type  Injury  

Event Description

This is a report of a patient who experienced a breach in aseptic technique during peritoneal dialysis therapy, resulting in the development of peritonitis.The breach in aseptic technique was further described as the patient touched the tip of their transfer set when changing fluids.The patient was hospitalized for the event with symptoms of abdominal pain and cloudy effluent.The patient was treated with intraperitoneal (ip) cefazolin (1g for 14 days, frequency not reported) and ip fortum (1g for 14 days, frequency not reported) for the event.The patient was eventually discharged from the hospital and reported to have recovered from the peritonitis.Dianeal therapies were ongoing.No additional information is available at this time.

Manufacturer Narrative

(b)(4).The patient was born on an unspecified date in 1956.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.

• 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: 3946064
• MDR Text Key: 4534778
• Report Number: 1416980-2014-23424
• Device Sequence Number: 1
• Product Code: KDJ
• Combination Product (y/n): N
• Reporter Country Code: VM
• 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
• Report Date: 06/25/2014

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: 06/25/2014
• Initial Date FDA Received: 07/21/2014
• 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 PD4 1.5%, DIANEAL PD4 2.5%
• Patient Outcome(s): Hospitalization; Required Intervention