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 06/28/2014

Event Type  Injury  

Manufacturer Narrative

(b)(4) it was reported that, the patient's fluid was found to be clear.On an unreported date, the patient had recovered from the event of peritonitis.Should additional relevant information become available, a follow-up will be submitted.

Event Description

It was reported that a patient experienced a break in aseptic technique during peritoneal dialysis (pd) therapy which caused peritonitis.On an unreported date, the patient was hospitalized for peritonitis.The treatment was with vancomycin injection (1 gm, stat), reflin injection (1gm, once a day) and meezat injection (1 gm, once a day) (routes not reported) for peritonitis.The outcome of the peritonitis event was unknown.The action taken with pd therapy was not reported.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.

• 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: 3952889
• MDR Text Key: 11956142
• Report Number: 1416980-2014-23857
• Device Sequence Number: 1
• Product Code: KDJ
• Combination Product (y/n): N
• Reporter Country Code: IN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 06/28/2014

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: 07/21/2014
• Initial Date FDA Received: 07/23/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/12/2014
• 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 PD2 1.5% AND 2.5% ULTRABAG.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 59 YR