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

Device Problem Contamination (1120)

Patient Problems Abdominal Pain (1685); Peritonitis (2252)

Event Date 05/26/2014

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 did not clean the exchange area before starting pd therapy.The peritonitis was manifested by abdominal pain.The same day, the patient was hospitalized and began treatment with vancomycin (1 gram once every 4 days, route unreported) for the peritonitis event.Three days after admission to the hospital, the patient was discharged.Eighteen days after the onset of peritonitis, vancomycin was discontinued and the patient was recovered from the event.On an unreported date, the patient was retrained on aseptic technique.Pd therapy was 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.

Manufacturer Narrative

(b)(4).It was reported that the break in aseptic technique included an unspecified touch contamination and also the patient did not wear a mask while performing peritoneal dialysis (pd) therapy.The reporter further stated that the patient was ¿ too relaxed with sanitary precautions which led to peritonitis¿ (not further specified).The patient was hospitalized for the peritonitis on the same day as the updated occurrence date and was discharged four days later.Twenty two days after onset (previously reported as eighteen days after onset) the peritonitis was resolved and the patient was recovered from the event.Should additional relevant information become available, a follow-up 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: 3930030
• MDR Text Key: 4598590
• Report Number: 1416980-2014-22379
• 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
• 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?: Yes
• Initial Date Manufacturer Received: 07/16/2014
• Initial Date FDA Received: 07/11/2014
• Supplement Dates Manufacturer Received: Not provided
• Supplement Dates FDA Received: 08/08/2014
• 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% AMBUFLEX; DIANEAL PD4 2.5% AND 4.25% DIANEAL 2.5% ULTRABAG
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 41 YR