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

Device Problem Contamination (1120)

Patient Problems Abdominal Pain (1685); Peritonitis (2252)

Event Date 06/11/2014

Event Type  Injury  

Event Description

It was reported that a patient experienced a breach in aseptic technique during peritoneal dialysis (pd) therapy, which resulted in peritonitis manifested by abdominal pain and cloudy effluent.The patient was hospitalized on the same day as onset of the peritonitis.Treatment for the peritonitis was not reported.At the time of this report, it was unknown if the patient had recovered from the peritonitis.The patient was retrained on aseptic technique.Pd therapy was reported to be ongoing.Additional information was requested but is not available.

Manufacturer Narrative

(b)(4).Upon follow up, it was reported that initial treatment for the peritonitis consisted of intraperitoneal (ip) cefazolin (2g per day) and ip gentamycin (80 mg per day).Treatment with cefazolin and gentamycin were discontinued after two days and the patient was then treated with ip vancomycin (1g per day) and ip amikacin (300mg per day).The patient eventually recovered from the peritonitis and was discharged from the hospital.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

(b)(4).Pt age: the patient was reported to have been born in 1967.This is a report of a use error, specifically a breach in aseptic technique, that 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.

• Type of Device: SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION
• Manufacturer (Section G): BAXTER HEALTHCARE CORPORATION
• Manufacturer Contact: christina arnt ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242703198
• MDR Report Key: 3927447
• MDR Text Key: 4666948
• Report Number: 1416980-2014-22087
• Device Sequence Number: 1
• Product Code: KDJ
• Combination Product (y/n): N
• Reporter Country Code: VM
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date: 06/16/2014

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
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 07/09/2014
• Initial Date FDA Received: 07/10/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/01/2014
• 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
• Treatment: DIANEAL
• Patient Outcome(s): Hospitalization; Required Intervention