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

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

Patient Problem Peritonitis (2252)

Event Date 06/09/2014

Event Type  Injury  

Manufacturer Narrative

Complaint no: (b)(4).The cause of this peritonitis was use error reported to be due to a break in aseptic technique by the patient.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.

Event Description

It was reported that a patient experienced a break in aseptic technique during peritoneal dialysis (pd) therapy which resulted in peritonitis.The break in aseptic technique was further described as touch contamination.The same day, the patient was hospitalized for the peritonitis event.While in the hospital, the patient was treated with vancomycin 1.75mg ip for peritonitis.Three days after admission to the hospital, the patient was discharged.On an unreported date, the patient was retrained on aseptic technique.At the time of this report, the patient was recovering from the event and pd therapy was ongoing.No additional information is available.

• Type of Device: SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
• Manufacturer (Section D): BAXTER HEATHCARE CORPORATION
• Manufacturer (Section G): BAXTER HEALTHCARE CORPORATION
• Manufacturer Contact: christina arnt ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242703198
• MDR Report Key: 3920096
• MDR Text Key: 21153642
• Report Number: 1416980-2014-21845
• 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
• 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: 06/13/2014
• Initial Date FDA Received: 07/08/2014
• 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 ULTRABAG PD4 2.5% AND EXTRANEAL; DIANEAL PD4 AMBUFLEX (2.5%)
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 59 YR