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 11/18/2015

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 the patient did not wear a mask.The patient was not hospitalized for the peritonitis event.One day after onset, the patient was treated with vancomycin injection 1 gram intravenously as a stat dose for the peritonitis event and then the vancomycin injection was to be given 1 gram intravenously every fifth day (duration not reported) for the peritonitis event.Beginning one day after onset, the patient was treated with a combination of piperacillin injection plus tazobactam injection 4.5 grams twice a day for fourteen days intravenously for the peritonitis event.It was not reported if dianeal therapy was ongoing.The patient was recovering from the peritonitis event.It was not reported if the patient was retrained on the proper aseptic technique.No additional information is available.

Manufacturer Narrative

(b)(4).On an unreported date, the patient was recovered from the previously reported peritonitis event (previously, the outcome was reported as recovering), the antibiotic treatment was completed, and the peritoneal effluent fluid was clear.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: kinga almasan ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 5293055
• MDR Text Key: 33392977
• Report Number: 1416980-2015-44230
• Device Sequence Number: 1
• Product Code: KDJ
• Combination Product (y/n): N
• Reporter Country Code: IN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date: 12/22/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/14/2015
• 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
• Date Manufacturer Received: 12/01/2015
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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
• Patient Outcome(s): Required Intervention
• Patient Age: 42 YR