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 Problem Peritonitis (2252)

Event Date 06/23/2014

Event Type  Injury  

Event Description

It was reported that a patient experienced a break in aseptic technique further described as improper hand washing and improper connection technique during peritoneal dialysis (pd) therapy, which caused bacterial peritonitis.The peritonitis was manifested by cloudy effluent.The patient was started oncefazolin sandoz (1 gram, once per day, intraperitoneally (ip) ) and gentamicin-sandoz 80mg (40mg, once per day, ip).The patient was hospitalized on the following day and was discharged four days later.The treatments with cefazolin sandoz and gentamicin-sandoz were discontinued about a week after being discharged.The following day, the patient was started on xorimax 500mg coated tablets (500mg, orally, 2 times per day) for the peritonitis.Four days later, the treatment with xorimax was also discontinued.The automated peritoneal dialysis (apd) treatment was ongoing and the patient recovered from the peritonitis.Additional information was requested, but is not available at this time.

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: 3994828
• MDR Text Key: 4955857
• Report Number: 1416980-2014-25771
• Device Sequence Number: 1
• Product Code: KDJ
• Combination Product (y/n): N
• Reporter Country Code: HU
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/14/2014

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: 07/14/2014
• 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: HOMECHOICE, DIANEAL PD4 1.36%
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 50 YR