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 Problems Abdominal Pain (1685); Peritonitis (2252)

Event Date 06/28/2014

Event Type  Injury  

Event Description

It was reported that a patient had an unspecified break in aseptic technique during peritoneal dialysis (pd) therapy which caused peritonitis manifested by abdominal pain and cloudy effluent.On the same day as onset, the patient was hospitalized for the event.On unknown date (same month as onset), the patient began treatment for the peritonitis, ip (intraperitoneally), with cefepime, 1gm (gram) daily for one week.Three days after being admitted to the hospital, the patient was discharged.On unknown date (in the month following onset month) the patient was treated for peritonitis, ip, with cefotaxime, 1gm daily for two weeks.On an unknown date the patient was retrained on aseptic technique for performing pd therapy.At the time of this report, the peritonitis was resolving, the patient was recovering, and dianeal therapies were ongoing.Additional information was requested but is not available.

Manufacturer Narrative

(b)(4).On (b)(6) 2014, the patient¿s pd effluent was clear and the patient denied abdominal pain.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).In the month following the peritonitis event; antibiotic therapy with cefotaxime was discontinued.It was reported that the patient had been achieving good ultrafiltration and had significant residual renal function.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

(b)(4).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: 3962006
• MDR Text Key: 4560951
• Report Number: 1416980-2014-24511
• 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,Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial,Followup,Followup
• Report Date: 07/03/2014

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: 09/30/2014
• Initial Date FDA Received: 07/28/2014
• Supplement Dates Manufacturer Received: Not provided; Not provided
• Supplement Dates FDA Received: 08/18/2014; 10/27/2014
• 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: MINICAP; DIANEAL PD4, 2.5% ULTRABAG; DIANEAL PD4, 2.5% AMBUFLEX; HOMECHOICE; MINICAP TRANSFER SET
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 66 YR