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

Device Problem Contamination (1120)

Patient Problem Peritonitis (2252)

Event Date 08/02/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).This report is for a breach in aseptic technique which 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.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a patient experienced a breach in aseptic technique which resulted in peritonitis coincident with peritoneal dialysis therapy.The breach in aseptic technique was further described as touch contamination.On the same date as onset, the patient was hospitalized for the event.Treatment information was not reported.After two days, the patient was discharged from the hospital and reported to be recovering from the peritonitis.It was not reported if the patient was retrained on proper aseptic technique.Dianeal and extraneal therapies were ongoing.Additional information is not available at this time.

• Type of Device: SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION
• Manufacturer (Section G): BAXTER HEALTHCARE CORPORATION
• Manufacturer Contact: kinga almasan ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 5038463
• MDR Text Key: 24378010
• Report Number: 1416980-2015-34106
• 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: company representative,consum
• Reporter Occupation: Other
• Report Date: 08/06/2015

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: Not provided
• Initial Date FDA Received: 08/28/2015
• 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 1.5% AMBUFLEX, DIANEAL 2.5% AMBUFLEX
• Patient Outcome(s): Hospitalization
• Patient Age: 60 YR