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 Problem Peritonitis (2252)

Event Type  Injury  

Manufacturer Narrative

(b)(4).On an unreported date ¿in late (b)(6)¿ the patient developed peritonitis.The cause of this peritonitis was use error reported to be due to a break in aseptic technique by the patient.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 there is any further relevant information from that review, a supplemental medwatch will be filed.

Event Description

It was reported that a patient experienced a breach in aseptic technique which resulted in peritonitis coincident with peritoneal dialysis (pd) therapy.The breach in aseptic technique was further described as the patient made a mistake of touch contamination.On an unreported date, the patient went to the emergency room for the event, however, was not hospitalized.On an unknown date, the patient began treatment for the peritonitis with vancomycin, intraperitoneally, (dose and frequency not reported).At the time of this report, treatment with vancomycin was ongoing, the peritonitis was resolving, the patient was recovering from the event, and dianeal/extraneal therapies were ongoing.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: 5208187
• MDR Text Key: 30645167
• Report Number: 1416980-2015-41252
• 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,consum
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 11/06/2015

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: 10/21/2015
• Initial Date FDA Received: 11/06/2015
• 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 PD4, 2.5% AMBUFLEX & EXTRANEAL
• Patient Outcome(s): Required Intervention