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 Bacterial Infection (1735); Peritonitis (2252); Complaint, Ill-Defined (2331)

Event Type  Injury  

Event Description

It was reported that a patient (pt) experienced peritonitis coincident with peritoneal dialysis (pd) therapy.The cause of the peritonitis was unknown, but was reported by the pt to be due to eating lettuce and the bacteria ¿got into the peritoneum.¿ it was not reported if the patient was hospitalized for the peritonitis event.Treatment for the peritonitis event was not reported.It was not reported if the patient was recovering or had recovered from the peritonitis event.It was reported that dianeal therapy was ongoing.Additional information was requested but is not available.This is report 1 of 3.

Manufacturer Narrative

(b)(4).This report involves the same patient as in cmplnt(b)(4).On an unreported date in 2014, the patient experienced peritonitis.A review of all batch record documents was performed for potentially associated lot numbers h14d12043 and h14e13121 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.The device was not returned; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.

• 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: 3961479
• MDR Text Key: 4608985
• Report Number: 1416980-2014-24458
• Device Sequence Number: 1
• Product Code: FKX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102936
• 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: 07/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 07/28/2014
• 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: 07/03/2014
• 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 LOW CALCIUM; HOMECHOICE, MINICAP, MINICAP TRANSFER SET
• Patient Outcome(s): Other