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

Device Problem Contamination (1120)

Patient Problem Peritonitis (2252)

Event Date 07/13/2014

Event Type  Injury  

Event Description

It was reported a patient experienced peritonitis coincident with peritoneal dialysis (pd) therapy.On an unreported date, the patient was treated with fortum 1 gm daily (route not reported) and intraperitoneal injections of vancomycin 1 gm (once in 5 days).The cause of the peritonitis was reported as a breach in aseptic technique further described as the pd bag hanging on the wall and the patient making a mistake.It was reported the patient was not hospitalized for the event.It was later reported that the patient's fluid was found to be clear and the patient had recovered from the 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: 3980410
• MDR Text Key: 4888369
• Report Number: 1416980-2014-25336
• Device Sequence Number: 1
• Product Code: KDJ
• Combination Product (y/n): N
• Reporter Country Code: IN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 07/13/2014

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: 07/13/2014
• Initial Date FDA Received: 08/05/2014
• 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% SOLUTION
• Patient Outcome(s): Required Intervention
• Patient Age: 64 YR