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

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

Patient Problems Abdominal Pain (1685); Purulent Discharge (1812); Peritonitis (2252)

Event Date 07/06/2014

Event Type  Injury  

Event Description

This is a report of a patient who experienced a breach in aseptic technique resulting in peritonitis coincident with continuous ambulatory peritoneal dialysis (capd) therapy.The peritonitis was manifested by cloudy effluent and abdominal pain.The breach in aseptic technique was further described as non-compliance.On the same day, the patient was hospitalized for the event of peritonitis.The patient received unknown treatment for peritonitis.Nine days later, the patient¿s catheter was removed due to lack of response to treatment.Dianeal therapies were discontinued, and hemodialysis therapy was initiated.The patient was retrained on aseptic technique.At the time of this report, the patient was hospitalized and not recovered from the event.No additional information is available at this time.

Manufacturer Narrative

(b)(4).The cause of this peritonitis was use error reported to be due to a break in aseptic technique. 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 supplemental report will be submitted.

• Type of Device: SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
• Manufacturer (Section D): BAXTER HEALTHCARE
• Manufacturer (Section G): BAXTER HEALTHCARE
• Manufacturer Contact: christina arnt ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242703198
• MDR Report Key: 3973887
• MDR Text Key: 15366764
• Report Number: 1416980-2014-25139
• 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: 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 1.5% AND DIANEAL PD4 2.5%
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 42 YR