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 06/13/2014

Event Type  Injury  

Event Description

It was reported that a patient experienced a break in aseptic technique further described as the line was breached during automated peritoneal dialysis (apd) therapy, which caused peritonitis.The peritonitis was manifested by abdominal pain and cloudy effluent.The next day after the onset, the patient was hospitalized for the peritonitis.The treatment for peritonitis was with ancef (1 gram, daily for 14 days, route not reported).The treatment with antibiotic was ongoing.The patient was discharged from the hospital after six days.The patient was reminded of aseptic technique when discharged from the hospital.At the time of this report, the patient was recovering from the peritonitis.The pd therapy was ongoing.Additional information was requested but was not available at this time.

Manufacturer Narrative

(b)(4).As the sample was not returned and the lot number is unknown, a device analysis cannot be completed.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.

Manufacturer Narrative

(b)(4).It was reported that the patient was recovered from the peritonitis event on an unknown date in the same month or the following month of the onset of the event of peritonitis.Following recovery from the previous diagnosis of peritonitis, the patient was diagnosed with recurrent peritonitis one week prior to this report.The cause was due to a break in aseptic technique during peritoneal dialysis therapy.The peritonitis was manifested by abdominal pain and cloudy effluent.On the same day as the onset of recurrent peritonitis, the patient was hospitalized for the peritonitis event.On the same day as the onset, the patient was treated with vancomycin (1 gram, daily for 14 days, and route not reported) for peritonitis.The patient was discharged from the hospital after four days.At the time of this report, the treatment with antibiotics was ongoing and the patient was recovering from the recurrent peritonitis event.The pd therapy remained ongoing.On an unreported date, the patient was re-trained on aseptic technique.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: 3927366
• MDR Text Key: 4666946
• Report Number: 1416980-2014-22080
• 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: 06/16/2014

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: 08/21/2014
• Initial Date FDA Received: 07/10/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 09/15/2014
• 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 2.5% AND 4.25% AMBUFLEX, HOMECHOICE
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 60 YR