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

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

Patient Problems Nausea (1970); Vomiting (2144); Peritonitis (2252)

Event Date 07/10/2014

Event Type  Injury  

Event Description

It was reported that the patient had a break in aseptic technique during peritoneal dialysis (pd) therapy while using unknown baxter pd disposables, which resulted in peritonitis.The break in aseptic technique was further described as not cleaning the exchange area before starting pd therapy and the patient had an inadvertent touch contamination.The peritonitis was manifested by nausea and vomiting.The patient was not hospitalized for the peritonitis.On an unreported date, the patient was treated with unspecified antibiotics for the event of peritonitis.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.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
• Manufacturer (Section G): BAXTER HEALTHCARE
• Manufacturer Contact: christina arnt ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242703198
• MDR Report Key: 3977429
• MDR Text Key: 21527156
• Report Number: 1416980-2014-25250
• 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: 07/10/2014

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: 07/10/2014
• Initial Date FDA Received: 08/04/2014
• 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, EXTRANEAL VIAFLEX
• Patient Outcome(s): Required Intervention
• Patient Age: 49 YR