MAUDE Adverse Event Report: BAXTER HEALTHCARE - MOUNTAIN HOME HOMECHOICE AUTOMATED PD SET WITH CASSETTE; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Catalog Number L5C4531

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

Patient Problems Urinary Tract Infection (2120); Peritonitis (2252)

Event Date 09/22/2013

Event Type  Injury  

Event Description

It was reported a patient experienced and was hospitalized the same day for peritonitis coincident with peritoneal dialysis (pd) therapy.The patient was treated with unspecified antibiotics.The cause of the peritonitis was reported to be a urinary tract infection, but this was not confirmed; therefore, the cause is unknown.On an unknown date during hospitalization, pd therapy was stopped.The pd catheter was removed and hemodialysis was started.The patient was discharged 7 days after admission.53 days after hospital discharge hemodialysis was stopped and pd therapy was restarted on an unknown date.At the time of this report, the patient had recovered from the peritonitis event.No additional information is available.This is report 1 of 3 involved in this peritonitis event.

Manufacturer Narrative

(b)(4).The device was not returned; therefore, an evaluation could not be conducted.A review of all batch record documents for potentially associated lot number h13g14035 was performed with no issues noted during the manufacturing process.There were no deviations from standard procedure and no exceptions related to the reported condition were noted.If additional relevant information is received, a supplemental medwatch will be filed.This report references the same patient as (b)(4).

• Brand Name: HOMECHOICE AUTOMATED PD SET WITH CASSETTE
• 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: 3613605
• MDR Text Key: 4067792
• Report Number: 1416980-2014-03930
• Device Sequence Number: 1
• Product Code: FKX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K923065
• 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: 01/15/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/07/2014
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Lay User/Patient
• Device Catalogue Number: L5C4531
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 01/15/2014
• 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 LOW CALCIUM 4.25 % SOLUTION; DIANEAL PD4 LOW CALCIUM 1.5% SOLUTION; DIANEAL PD4 LOW CALCIUM 2.5% SOLUTION; HOMECHOICE, MINICAP TRANSFER SET, MINICAP
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 57 YR