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

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

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

Event Date 06/06/2014

Event Type  Injury  

Event Description

It was reported that a patient experienced a break in aseptic technique during peritoneal dialysis (pd) therapy which resulted in peritonitis.The peritonitis was manifested by abdominal pain.The same day, the patient was hospitalized and began treatment with vancomycin iv and ip (dose, frequency, and administration rate were not reported).Seven days after the onset of peritonitis, vancomycin therapy was discontinued, the patient was recovered from the event and discharged from the hospital.On an unreported date, the patient was retrained on proper aseptic technique.Pd therapy was ongoing.Additional information was requested but is not available.

Manufacturer Narrative

(b)(4).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.

• Type of Device: SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
• Manufacturer (Section D): BAXTER HEATHCARE CORPORATION
• Manufacturer (Section G): BAXTER HEALTHCARE CORPORATION
• Manufacturer Contact: christina arnt ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242703198
• MDR Report Key: 3935688
• MDR Text Key: 4575943
• Report Number: 1416980-2014-22654
• 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: 06/20/2014

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: 06/20/2014
• Initial Date FDA Received: 07/15/2014
• 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 PD2 1.5%, 2.5% AND 4.25% AMBUFLEX
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 11 YR