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

Device Problem Contamination (1120)

Patient Problem Peritonitis (2252)

Event Date 11/30/2015

Event Type  Injury  

Manufacturer Narrative

(b)(4).As the sample was not returned and the lot number is unknown, a device analysis cannot be completed.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a patient experienced peritonitis coincident with peritoneal dialysis therapy.The event was manifested by cloudy effluent.The cause of the peritonitis was unknown.The patient was not hospitalized for the event.On the same day as the event onset, the patient started treatment with intraperitoneal vancomycin (dose, frequency, and duration not reported) and intraperitoneal fortaz (dose, frequency, and duration not reported) for peritonitis.Dianeal and extraneal therapies remained ongoing.At the time of this report, the patient remains on antibiotic therapy and is recovering.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: 5335645
• MDR Text Key: 34690447
• Report Number: 1416980-2015-45918
• 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: company representative,consum
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 12/30/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 12/30/2015
• 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
• Date Manufacturer Received: 12/08/2015
• 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 1.5% PD4 AMBUFLEX, HOMECHOICE
• Patient Outcome(s): Required Intervention
• Patient Age: 35 YR