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

Device Problems Contamination (1120); Improper or Incorrect Procedure or Method (2017)

Patient Problem Peritonitis (2252)

Event Date 06/17/2014

Event Type  Injury  

Event Description

It was reported that a patient experienced a break in aseptic technique during peritoneal dialysis (pd) therapy which resulted in peritonitis.The break in aseptic technique was further described as the patient forgot to wash their hands prior to performing peritoneal dialysis (pd) therapy.The patient was not hospitalized for the event.The patient was treated with unspecified antibiotics for peritonitis.At the time of this report, the patient had recovered from the event.Pd therapy was discontinued and the patient was performing hemodialysis.No additional information is available.

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.

Manufacturer Narrative

(b)(4).One day after the onset of peritonitis, the patient was treated with levaquin (oral, dose and frequency not reported) for peritonitis.The next day, the patient felt worse and went to the emergency room for the peritonitis.On the same day, the patient received intravenous (iv) antibiotics (name, dose, and frequency unknown) for peritonitis.On the same day, intravenous antibiotics were withdrawn.The patient was released from the er on the same day.Eight days after the onset of peritonitis, the patient was hospitalized for an unrelated event.During the hospitalization, the patient's pd catheter was removed and the patient's pd therapy was discontinued.The patient was started on hemodialysis (hd) therapy.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 HEATHCARE CORPORATION
• Manufacturer (Section G): BAXTER HEALTHCARE CORPORATION
• Manufacturer Contact: christina arnt ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242703198
• MDR Report Key: 3928018
• MDR Text Key: 4531834
• Report Number: 1416980-2014-22172
• 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,Followup
• Report Date: 06/17/2014

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?: No
• Initial Date Manufacturer Received: 07/17/2014
• Initial Date FDA Received: 07/10/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/11/2014
• 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 PD4 1.5% AND 2.5% AMBUFLEX
• Patient Outcome(s): Required Intervention
• Patient Age: 79 YR