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 06/11/2014

Event Type  Injury  

Event Description

It was reported that a patient experienced a break in aseptic technique further described as the patient did not wash hands or clean the area before the start of peritoneal dialysis (pd) therapy, which caused peritonitis.On the same day as the onset, the patient was hospitalized for the peritonitis.The treatment was with vancomycin intraperitoneally (ip) (dose and frequency not reported), fortaz ip (dose and frequency not reported), gentamycin ip, (dose and frequency not reported) and cipro orally (dose and frequency not reported) for the peritonitis.The patient was discharged from the hospital after three days.At the time of this report, the patient was recovering from the peritonitis.The pd therapy was ongoing.The patient was retrained on aseptic technique.Additional information was requested but was not available at this time.

Manufacturer Narrative

(b)(4).On an unreported date in the same month as the onset of the peritonitis, the patient was completely recovered from the peritonitis event.Should additional relevant information become available, a follow up report will be submitted.

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.

• 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: 3919646
• MDR Text Key: 4515625
• Report Number: 1416980-2014-21803
• 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: 06/13/2014

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: 07/08/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/01/2014
• 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% AMBUFLEX AND EXTRANEAL
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 40 YR