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 Date 06/19/2014

Event Type  Injury  

Event Description

It was reported that the patient had a break in aseptic technique, described as the disconnect cap falling off the transfer set without the patient knowing, during peritoneal dialysis (pd) which caused peritonitis.The peritonitis was manifested by cloudy effluent.The patient was not hospitalized for the peritonitis event.On unreported date(s), the patient was treated with cefazolin (1gm, daily, intraperitoneally) for 2 weeks and ceftazidime (1gm, daily, intraperitoneally) for 2 weeks for the peritonitis event.It was not reported if dianeal therapy was ongoing.It was reported that the patient was retrained on aseptic technique and their transfer set was replaced.It was reported that the patient was recovered from the peritonitis event.Additional information was requested but is not available.This is report 1 of 2.

Manufacturer Narrative

(b)(4).The device was not returned; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

(b)(4).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: 3933051
• MDR Text Key: 4579000
• Report Number: 1416980-2014-22595
• 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,Followup
• Report Date: 06/19/2014

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?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/15/2014
• Initial Date FDA Received: 07/14/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 10/10/2014
• 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: DIANEAL 2.5% PD4 AMBUFLEX, TRANSFER SET
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR