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

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

Patient Problem Peritonitis (2252)

Event Date 07/02/2014

Event Type  Injury  

Event Description

It was reported a patient experienced peritonitis coincident with peritoneal dialysis (pd) therapy.The cause of the peritonitis was a breach in aseptic technique, further described as touch contamination.On an unreported date, the patient was treated with cefzil (dose, route, and frequency unknown).On an unknown date, (after pd culture results were received) cefzil was discontinued and vancomycin (dose, route and frequency not reported) was initiated.It was reported the patient was not hospitalized for the event.At the time of this report, antibiotic treatment was ongoing and the patient was recovering from this peritonitis event.No additional information is available.

Manufacturer Narrative

Complaint no: (b)(4).The cause of this peritonitis was use error.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.If additional relevant information is received, a supplemental medwatch will be filed.

• 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: 3961577
• MDR Text Key: 19585816
• Report Number: 1416980-2014-24470
• 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,Company Representative
• Reporter Occupation: Other
• 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
• 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 PD4 LOW CALCIUM 1.5% AND 2.5% SOLUTIONS
• Patient Outcome(s): Required Intervention
• Patient Age: 43 YR