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 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 (pd) therapy.The breach in aseptic technique was further described as touch contamination.It is unknown if the patient was hospitalized for the event.The patient was treated intraperitoneally with unknown antibiotics, and dianeal and extraneal therapies were discontinued.At the time of this report, the patient was recovered from the event.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.If there is any further relevant information from that review, a supplemental medwatch will be filed.

• 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: 3947191
• MDR Text Key: 4600548
• Report Number: 1416980-2014-23479
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 06/26/2014

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
• Initial Date Manufacturer Received: 06/26/2014
• Initial Date FDA Received: 07/21/2014
• 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 PD4 2.5% AMBUFLEX, EXTRANEAL VIAFLEX
• Patient Outcome(s): Required Intervention