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 01/26/2014

Event Type  Injury  

Event Description

It was reported that a patient experienced a breach in aseptic technique during peritoneal dialysis (pd) therapy, which resulted in peritonitis.The patient was hospitalized for the peritonitis.Treatment was not reported.On an unreported date, the patient¿s pd catheter was removed and the patient was switched to hemodialysis.The patient was discharged from the hospital ten days after onset and reported to be recovering from the peritonitis event.The patient resumed pd therapy after several months of hemodialysis therapy.The patient was retrained on proper aseptic technique.Additional information was requested but is not available.

Manufacturer Narrative

(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.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.

• 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: 3959607
• MDR Text Key: 16992807
• Report Number: 1416980-2014-24396
• 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: 07/02/2014

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: 07/02/2014
• 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 1.5% AND 2.5% LOW CALCIUM
• Patient Outcome(s): Hospitalization
• Patient Age: 64 YR