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

Device Problem Contamination (1120)

Patient Problem Peritonitis (2252)

Event Type  Injury  

Event Description

While being hospitalized for an unrelated event, the patient experienced peritonitis manifested by cloudy effluent coincident with peritoneal dialysis (pd) therapy.The cause of the peritonitis was related to a touch contamination.On unreported date(s), the patient was treated with vancomycin intraperitoneally (ip) for two doses (dosage, frequency, and duration not reported) for the peritonitis event.On an unreported date, the patient was discharged from the hospital.It was reported the patient was recovering from the peritonitis event.Dianeal and extraneal therapies were ongoing.Additional information was requested but is not available.

Manufacturer Narrative

Complaint no: (b)(4).On an unreported date in (b)(6) 2014 during hospitalization, the patient experienced peritonitis.Should additional relevant information become available, 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: 3973593
• MDR Text Key: 4751234
• Report Number: 1416980-2014-25105
• 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: 07/10/2014

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: 08/01/2014
• 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 2.5% LOW CALCIUM PD4 AMBUFLEX; UNSPECIFIED ANTIBIOTIC FOR GROIN WOUND INFECTION; DIANEAL 2.5% PD4 ULTRABAG, EXTRANEAL; CONTINUOUS AMBULATORY PERITONEAL DIALYSIS (CAPD); HOMECHOICE
• Patient Outcome(s): Hospitalization; Other; Required Intervention