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 07/04/2014

Event Type  Injury  

Event Description

It was reported that a patient had a break in aseptic technique during peritoneal dialysis (pd) which caused peritonitis.The break in aseptic technique was further described as patient made a mistake/touch contamination.On the same day as the onset, the patient was hospitalized for the peritonitis event.On unreported date(s), the patient was treated with unspecified antibiotic(s) intraperitoneally (medication, dosage, and frequency not reported) for the peritonitis event.After five days of hospitalization for peritonitis, the patient was discharged.It was not reported if the patient was retrained on proper aseptic technique.It was reported that the patient was recovering from the peritonitis event.Dianeal therapies were ongoing.Additional information was requested but is not available.

Manufacturer Narrative

(b)(4).The cause of this peritonitis was use error.Per baxter labeling, users are instructed to use aseptic technique when performing peritoneal dialysis therapy.The device was not returned; therefore, a device analysis could not be completed.If any relevant information is obtained, 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: 3970334
• MDR Text Key: 4636005
• Report Number: 1416980-2014-24782
• 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: Health Professional,Company Representative
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 07/10/2014

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: 07/10/2014
• Initial Date FDA Received: 07/31/2014
• 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 1.5% AND 2.5% LOW CALCIUM SINGLEBAG
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 35 YR