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 05/30/2014

Event Type  Injury  

Event Description

It was reported that a patient experienced a breach in aseptic technique during peritoneal dialysis (pd) therapy, which resulted in peritonitis.The breach in aseptic technique was further described as patient made a mistake/touch contamination.The patient was hospitalized for the peritonitis.The patient was treated with ceftazidime(1gram daily for 3 weeks, route not reported) for peritonitis.The patient was discharged from the hospital two weeks after being admitted.It was reported that the patient was recovered from the peritonitis.It was not reported if the patient would be retrained or if the patient had been retrained on aseptic technique.Pd therapy was ongoing.Additional information was requested but is not available.

Manufacturer Narrative

(b)(4).This is a report of a use error that resulted in peritonitis.Per baxter labeling, users are instructed to use aseptic technique when performing peritoneal dialysis therapy. a review of the label for the product family will be conducted.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: 3930928
• MDR Text Key: 4574140
• Report Number: 1416980-2014-22479
• 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: 06/17/2014

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: 06/17/2014
• Initial Date FDA Received: 07/13/2014
• 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 2.5% LOW CALCIUM ULTRABAG
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 61 YR