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 Problem Peritonitis (2252)

Event Date 07/01/2014

Event Type  Injury  

Event Description

It was reported that a patient experienced a break in aseptic technique during peritoneal dialysis (pd) therapy which resulted the development of peritonitis.The break in aseptic technique was further described as the patient made mistake/touch contamination.The patient was hospitalized for the event and treated with intraperitoneal ceftazidime (1 gram, frequency not reported).Two days after admission to the hospital, the patient was discharged.At the time of this report, the patient was recovered from the peritonitis.Antibiotic treatment and pd therapy were ongoing.Additional information was requested but is not available.

Manufacturer Narrative

Complaint no: (b)(4).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: 3973931
• MDR Text Key: 16856208
• Report Number: 1416980-2014-25142
• 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
• Report Date: 07/09/2014

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: 07/09/2014
• Initial Date FDA Received: 08/01/2014
• 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 2.5% AMBUFLEX; DIANEAL PD4 1.5% ULTRABAG
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 31 YR