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 06/12/2014

Event Type  Injury  

Event Description

It was reported that a patient experienced a breach in aseptic technique during peritoneal dialysis (pd) therapy, which resulted in peritonitis.The breach in aseptic technique was not further described.The patient was not hospitalized for the peritonitis.The patient was treated with unknown intraperitoneal antibiotics (dose, route and frequency not reported) for the event.At the time of this report, the patient had recovered from the peritonitis and was retrained on aseptic technique.Pd therapy was reported to be ongoing.Additional information was requested but is not available.

Manufacturer Narrative

(b)(4).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.As the sample was not returned, a complete device analysis cannot be performed.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: 3950325
• MDR Text Key: 17263450
• Report Number: 1416980-2014-23637
• 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: 06/27/2014

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: 06/27/2014
• Initial Date FDA Received: 07/22/2014
• 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 ULTRABAG; DIANEAL PD4 AMBUFLEX
• Patient Outcome(s): Required Intervention
• Patient Age: 78 YR