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); No Code Available (3191)

Event Date 07/12/2014

Event Type  Injury  

Event Description

It was reported that a patient (pt) had a break in aseptic technique during peritoneal dialysis (pd) therapy which caused peritonitis.The break in aseptic technique was further described as the patient made an unspecified touch contamination.The peritonitis was manifested by a cloudy effluent bag, abdominal pain and ¿pinch in stomach¿.The patient was not hospitalized for the event.On the same day as onset, the patient was treated for the peritonitis with cefazolin and fortaz (1 gram, daily, ip-intraperitoneally).At the time of this report, antibiotic treatment was ongoing.Five days after onset, the patient was retrained on proper 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).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.

• 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: 3994635
• MDR Text Key: 4824241
• Report Number: 1416980-2014-25756
• 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
• Report Date: 07/16/2014

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: 07/16/2014
• Initial Date FDA Received: 08/08/2014
• 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 PD4, 2.5% AMBUFLEX; HOMECHOICE; DIANEAL PD4, 1.5% AMBUFLEX
• Patient Outcome(s): Required Intervention
• Patient Age: 51 YR