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

Device Problem Contamination (1120)

Patient Problem Peritonitis (2252)

Event Date 02/05/2016

Event Type  Injury  

Manufacturer Narrative

(b)(4).This report is for a breach in aseptic technique which resulted in peritonitis.Per baxter labeling, users are instructed to use aseptic technique when performing peritoneal dialysis therapy.A review of the label for the product family will be conducted.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a patient experienced a break in aseptic technique during peritoneal dialysis (pd) therapy, resulting in peritonitis.The breach in aseptic technique was further described as ¿the patient seemed to have trouble with performing aseptic technique.¿ on the same day as the event onset, the patient was hospitalized for peritonitis.The patient was treated with unspecified antibiotics (drug names, doses, routes, frequencies, and durations not reported) for peritonitis.Action taken with pd therapy was not reported.At the time of this report, the patient is recovering.It was not reported if the patient was retrained on proper aseptic technique.No additional information is available.

Manufacturer Narrative

(b)(4).Upon follow up it was reported the peritonitis was manifested by chills and cloudy effluent.At the time of this report the patient was recovering from this peritonitis event.Pd therapy was ongoing.Concomitant medical products: the dianeal solution was clarified to be reguneal solutions should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

(b)(4).Additional information: upon follow up, it was reported by a physician that the cause of this peritonitis event ¿could not be detected¿, the cause will continue to be assessed as breach in aseptic technique.The patient was discharged fourteen days after admission.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: 5471766
• MDR Text Key: 39414732
• Report Number: 1416980-2016-04340
• 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,Followup
• Report Date: 03/25/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/01/2016
• 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: 03/02/2016
• 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