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

Catalog Number L5C4531

Device Problem Contamination (1120)

Patient Problems Inflammation (1932); Peritonitis (2252)

Event Date 02/02/2014

Event Type  Injury  

Event Description

This is report 1 of 3 involved in this event.This is a report of a patient who experienced and was hospitalized for peritonitis coincident with therapy for peritoneal dialysis.Therapy was ongoing.The peritonitis manifested as inflammation and an elevated white cell count.The patient began treatment with an unspecified antibiotic for the event and later switched to ancef intraperitoneally (1gram, daily for 10 days).The patient was discharged from the hospital after four days with ongoing treatment.The cause of the peritonitis was unknown.At the time of this report, the patient was recovering from the peritonitis.No additional information is available at this time.

Manufacturer Narrative

(b)(4).A batch review was conducted for potentially associated lot numbers h13j29020 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.As the sample was not returned, a complete device analysis cannot be performed.Should additional relevant information become available, a follow-up report will be submitted.This is 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: 3655293
• MDR Text Key: 20658918
• Report Number: 1416980-2014-07200
• 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: 02/07/2014

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
• Device Catalogue Number: L5C4531
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 02/07/2014
• Initial Date FDA Received: 03/03/2014
• 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: 1.5% DIANEAL PD4 ULTRABAG, MINICAP TRANSFER SET,; HOMECHOICE, 1.5% DIANEAL PD4 AMBUFLEX, MINICAP; 2.5% DIANEAL PD4 ULTRABAG,
• Patient Outcome(s): Hospitalization; Required Intervention
• Patient Age: 38 YR