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

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

Patient Problem Peritonitis (2252)

Event Date 06/17/2014

Event Type  Injury  

Event Description

This is a report of a patient who experienced a breach in aseptic technique resulting in peritonitis coincident with peritoneal dialysis.The breach in aseptic technique was further described as the patient made a mistake.On an unreported date, the patient was hospitalized for the event.The patient was treated with intraperitoneal (ip) vancomycin injection (1g immediately, frequency not reported), ip amikacin injection (100mg,once daily), ip ecomer injection (1g, once daily), reflin injection (1g, once daily, route not reported), and heparin injection (500iu each bag, route and frequency not reported) for peritonitis.Action with the dianeal therapy was not reported.Patient outcome is unknown.No additional information is available at this time.

Manufacturer Narrative

Complaint no: (b)(4).The cause of this peritonitis was use error, breach in aseptic technique further described as patient made a mistake. 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 MANUFACTURING FACILITY
• Manufacturer (Section G): BAXTER MANUFACTURING FACILITY
• Manufacturer Contact: christina arnt ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242703198
• MDR Report Key: 3927926
• MDR Text Key: 4538070
• Report Number: 1416980-2014-22165
• 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: Health Professional
• Type of Report: Initial
• Report Date: 06/17/2014

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: 06/17/2014
• 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% ULTRABAG THERAPY
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 56 YR