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

Device Problems Contamination (1120); Improper or Incorrect Procedure or Method (2017)

Patient Problems Abdominal Pain (1685); Purulent Discharge (1812); Peritonitis (2252); No Code Available (3191)

Event Date 06/16/2014

Event Type  Injury  

Event Description

This is a report of a patient who experienced a breach in aseptic technique resulting in peritonitis coincident with continuous ambulatory peritoneal dialysis (capd) therapy.The peritonitis was manifested by abdominal pain, cloudy effluent and effluent with elevated white count.The patient was not hospitalized for the event.On the same day, the patient began treatment with intraperitoneal (ip) vancomycin for peritonitis and ip gentamycin for cloudy effluent, (dose and frequencies not reported).Nineteen days later, treatment with gentamycin was discontinued, and on an unknown date, treatment with vancomycin was discontinued.Dianeal therapy was ongoing.The patient was reported to have been recovering from this occurrence of peritonitis.Twenty-two days after the first onset of peritonitis, the patient experienced recurrent peritonitis manifested by abdominal pain, cloudy effluent and effluent with elevated white blood cell count.On the same day, the patient again started treatment with ip vancomycin for peritonitis and ip gentamycin for cloudy effluent, (dose and frequencies not reported).Dianeal therapy was still ongoing.On an unreported date, the patient was retrained in aseptic technique.At the time of this report, treatment with vancomycin and gentamycin were ongoing, and the patient was not recovered from the event.No additional information is available at this time.

Manufacturer Narrative

Complaint no: (b)(4).The cause of this peritonitis was use error reported to be due to a break in aseptic technique. per baxter labeling, users are instructed to use aseptic technique when performing peritoneal dialysis therapy. a formal 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
• Manufacturer (Section G): BAXTER HEALTHCARE
• Manufacturer Contact: christina arnt ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242703198
• MDR Report Key: 3962052
• MDR Text Key: 19721679
• Report Number: 1416980-2014-24514
• 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: Consumer,Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/03/2014

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: 07/03/2014
• Initial Date FDA Received: 07/28/2014
• 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% PD4 ULTRABAG
• Patient Outcome(s): Required Intervention
• Patient Age: 62 YR