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

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

Patient Problem Peritonitis (2252)

Event Date 06/15/2014

Event Type  Injury  

Event Description

It was reported that the patient had a break in aseptic technique during peritoneal dialysis (pd) therapy while using unknown baxter pd disposables, which caused peritonitis.The break in aseptic technique was further described as not wearing a mask during setup.The patient was hospitalized on the same day as the onset for the event of peritonitis.On an unreported date, the patient began treatment with vancomycin injections (dose: 2 gram, frequency: started immediately and route of administration: not reported) and cefepime injections (dose: 1 gram, frequency: once a day and route of administration: not reported) for peritonitis.The outcome of the patient was unknown.Dianeal therapies were ongoing.No additional information is available.

Manufacturer Narrative

(b)(4).The cause of this peritonitis was use error described as 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: 3927314
• MDR Text Key: 19092928
• Report Number: 1416980-2014-22074
• 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
• Report Date: 06/15/2014

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: 06/15/2014
• Initial Date FDA Received: 07/10/2014
• 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% PD2 ULTRABAG; DIANEAL 1.5% PD2 AMBUFLEX,
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 52 YR