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

Device Problems Contamination (1120); Improper or Incorrect Procedure or Method (2017); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Abdominal Pain (1685); Fever (1858); Pain (1994); Chills (2191); Peritonitis (2252)

Event Date 06/15/2014

Event Type  Injury  

Manufacturer Narrative

(b)(4).The manifestations of the peritonitis event were further specified to include fever, chills and loss of appetite.The breach in aseptic technique was further described as lack of personal hygiene and infection prevention practices in between treatments (clean hands and nails, no scratching of access area).On an unreported date, the patient began treatment with ceftazidime (dose, frequency and route not reported) for peritonitis.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

(b)(4).It was reported that the breach in aseptic technique was further specified as the patient is non-compliant with infection control practices such as hand washing and aseptic technique and the wearing of a mask when performing the connect and disconnect procedures.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a patient experienced a break in aseptic technique during continuous ambulatory peritoneal dialysis (capd) therapy, which caused bacterial peritonitis.The break in aseptic technique was further described as touch contamination, the patient not wearing a mask, and poor sanitary practices).The peritonitis was manifested by abdominal pain and cloudy effluent.On the same day as the onset, the patient was hospitalized for peritonitis.The patient was treated with vancomycin (dose, route and frequency not reported) for the peritonitis.At the time of this report, the treatment with antibiotic was ongoing and the patient remained hospitalized.The patient was reported to be recovering from the peritonitis.The pd therapy was ongoing.Additional information was requested but was not available at this time.

Manufacturer Narrative

(b)(4).As the sample was not returned and the lot number is unknown, a device analysis cannot be completed.This is a report of a use error 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: 3929746
• MDR Text Key: 15764913
• Report Number: 1416980-2014-22336
• 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: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 06/18/2014

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: 01/05/2015
• Initial Date FDA Received: 07/11/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 01/15/2015; 01/20/2015
• 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
• Treatment: GENTAMICIN (APPLIED DAILY TO THE EXIT SITE); DIANEAL 2.5% PD4 ULTRABAG.
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 57 YR