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 07/21/2014

Event Type  Injury  

Event Description

It was reported that a patient had a break in aseptic technique during continuous ambulatory peritoneal dialysis (capd) therapy which caused peritonitis.The break in aseptic technique was further described as the patient was doing capd without undergoing proper training (regarding aseptic technique) for performing capd therapy (no further detail provided).One day after onset, the patient was hospitalized for the event.On an unreported date, the patient was treated with injection (inj) reflin (1 gram per day, night dwell) and inj fortum (1 gram per day, night dwell), intraperitoneally (ip) for peritonitis.The outcome of the peritonitis was unknown.At the time of this report, dianeal therapy was ongoing and the status of the extraneal therapy was not reported.No additional information is available at this time.

Manufacturer Narrative

(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.

• 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: 4013395
• MDR Text Key: 4689581
• Report Number: 1416980-2014-26696
• Device Sequence Number: 1
• Product Code: KDJ
• Combination Product (y/n): N
• 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: 07/22/2014

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: 07/22/2014
• Initial Date FDA Received: 08/15/2014
• 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 PD2, 1.5% ULTRABAG; EXTRANEAL
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 71 YR