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 11/11/2015

Event Type  Injury  

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.

Event Description

It was reported that a patient experienced a breach in aseptic technique which resulted in peritonitis coincident with peritoneal dialysis (pd) therapy.The breach in aseptic technique was further described as the patient did not wear a mask while performing pd therapy.The patient was not hospitalized for the event.On an unreported date, the patient began treatment for the peritonitis with injection (inj.) ceftazidime (500 milligram (mg), frequency and route of administration not reported) and cefazolin (500 mg given in all three bags intraperitoneally, frequency not reported).At the time of this report, the patient was doing well, fluid was clear and treatment with antibiotics was ongoing.On an unreported date, the peritonitis was resolved and the patient was recovered from the event.It was not reported if dianeal therapy was ongoing or whether the patient was re-trained in proper aseptic technique.No additional information is available.

• Type of Device: SET, ADMINISTRATION, FOR PERITONEAL DIALYSIS, DISPOSABLE
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION
• Manufacturer (Section G): BAXTER HEALTHCARE CORPORATION
• Manufacturer Contact: kinga almasan ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 5261702
• MDR Text Key: 32546916
• Report Number: 1416980-2015-43198
• Device Sequence Number: 1
• Product Code: KDJ
• Combination Product (y/n): N
• Reporter Country Code: IN
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,foreig
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 12/02/2015

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: 11/11/2015
• Initial Date FDA Received: 12/02/2015
• 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 ULTRABAG 2.5%
• Patient Outcome(s): Required Intervention
• Patient Age: 60 YR