MAUDE Adverse Event Report: BAXTER HEALTHCARE - MOUNTAIN HOME; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Inflammation (1932); Peritonitis (2252)

Event Date 10/02/2014

Event Type  Injury  

Event Description

It was reported that a patient experienced peritonitis coincident with peritoneal dialysis therapy.The day before diagnosis, the patient was hospitalized for an unspecified event.The peritonitis was manifested by an inflamed peritoneum.The cause of the peritonitis was unknown.The patient was treated with vancomycin (dose, route, frequency and duration not reported) for the event.On an unknown date, the patient¿s pd catheter was removed and the patient was placed on hemodialysis.The patient was reported to have recovered from the peritonitis.No additional information is available.This is report 3 of 4 involved in this event.

Manufacturer Narrative

(b)(4).This report involves an unknown baxter cassette.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.(b)(4).

• Type of Device: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): BAXTER HEALTHCARE - MOUNTAIN HOME; 1900 n highway 201; mountain home AR 72653
• Manufacturer (Section G): BAXTER HEALTHCARE - MOUNTAIN HOME; 1900 n highway 201; mountain home AR 72653
• Manufacturer Contact: christina arnt ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242703198
• MDR Report Key: 4215186
• MDR Text Key: 5038509
• Report Number: 1416980-2014-38048
• Device Sequence Number: 1
• Product Code: FKX
• 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: Other
• Type of Report: Initial
• Report Date: 10/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 10/30/2014
• 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
• Date Manufacturer Received: 10/06/2014
• 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 PD4 AMBUFLEX, HOMECHOICE; TRANSFER SET, TITANIUM ADAPTER, MINICAP
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 84 YR