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 Problems Abdominal Pain (1685); Peritonitis (2252)

Event Date 09/21/2015

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.There was no further description of the breach in aseptic technique.Peritonitis was manifested by abdominal pain.On the day of onset, the patient was hospitalized for the peritonitis event.Beginning on the day of onset, the patient was treated with unspecified antibiotics (route, medication, dosage, frequency, and duration not reported) for the peritonitis event.Antibiotic treatment was ongoing.The care plan was to treat the patient with intraperitoneal vancomycin (dosage, frequency, and duration not reported) upon hospital discharge for the peritonitis event.On an unreported date, dianeal therapies were discontinued and the patient was switched to hemodialysis therapy, but the care plan was to return the patient to peritoneal dialysis therapy upon discharge from the hospital.Hospitalization 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.

• 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: 5150828
• MDR Text Key: 28293936
• Report Number: 1416980-2015-38975
• 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,health
• Reporter Occupation: Nurse
• Report Date: 10/14/2015

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 10/14/2015
• 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 2.5% AND 4.25% LOW CALCIUM ULTRABAG
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 59 YR