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

Device Problem Contamination (1120)

Patient Problems Diarrhea (1811); Vomiting (2144); Peritonitis (2252)

Event Date 01/22/2016

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 bacterial peritonitis coincident with continuous ambulatory peritoneal dialysis (capd) therapy.The breach in aseptic technique was further described as the patient did not wear a mask.Peritonitis was manifested by diarrhea, vomiting, and cloudy effluent.On the day of onset, the patient was hospitalized for the bacterial peritonitis.On an unreported date, the patient began treatment with unspecified antibiotics (route, medication, dosage, frequency, and duration not reported) for the bacterial peritonitis.Dianeal therapies were ongoing.The patient was recovering from the bacterial peritonitis.On an unreported date, the patient was retrained on the proper aseptic technique.No additional information is available.

Manufacturer Narrative

(b)(4).Upon follow up it was reported the twenty-three days after the peritonitis onset, the patient was discharged from the hospital and was recovered from this peritonitis event.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: 5451051
• MDR Text Key: 38681041
• Report Number: 1416980-2016-03821
• 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: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 03/08/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/22/2016
• 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
• Date Manufacturer Received: 02/15/2016
• 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): Hospitalization; Required Intervention
• Patient Age: 32 YR