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

Device Problem Microbial Contamination of Device (2303)

Patient Problems Bacterial Infection (1735); Peritonitis (2252); Test Result (2695)

Event Date 12/08/2015

Event Type  Injury  

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.

Event Description

It was reported that a patient experienced a breach in aseptic technique which resulted in peritonitis coincident with continuous ambulatory peritoneal dialysis (capd) therapy.The breach in aseptic technique was further described as the patient made an unspecified mistake during therapy.On an unreported date, the patient was hospitalized for the peritonitis.On an unreported date, the patient began treatment with vancomycin (1gram, stat, route was not reported) and injection tazin (4.5grams, twice daily, intravenously).At the time of this report, the peritonitis was resolving, the patient was recovering, and dianeal therapy was ongoing.It was not reported if extraneal therapy was ongoing.No additional information is available.

Manufacturer Narrative

(b)(4).Upon follow up it was reported, on an unknown date, the patient¿s fluid was not clear.Also on an unknown date, the patient¿s pd therapy was discontinued and the patient was switched to hemodialysis.At the time of this report, the patient had not recovered.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: kinga almasan ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 5332374
• MDR Text Key: 34587900
• Report Number: 1416980-2015-45810
• Device Sequence Number: 1
• Product Code: KDJ
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Type of Report: Initial,Followup
• Report Date: 01/13/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/29/2015
• 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
• Date Manufacturer Received: 12/23/2015
• 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
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 73 YR