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

Catalog Number R5C4479C

Device Problems Fluid/Blood Leak (1250); Human-Device Interface Problem (2949)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 05/25/2014

Event Type  malfunction  

Event Description

It was reported that a homechoice automated pd set with cassette had a small leak from the patient line.This was identified during dwell cycle one of four of peritoneal dialysis (pd) therapy while the patient was connected.The patient reported that they had opened the box of supplies with a razor knife and may have damaged the patient line in doing so.The technical service representative assisted the patient in ending therapy and advised the patient to restart therapy with new supplies.There was no patient injury or medical intervention reported.No additional information is available.

Manufacturer Narrative

(b)(4).As the cassette was not returned and the lot number is unknown, a device analysis cannot be completed.However, the patient reported that they made a mistake and punctured a hole in the patient line of the disposable cassette.Proper user instructions are addressed in ¿the homechoice and homechoice pro apd systems patient at-home guide¿ which is shipped with every homechoice device.The guide has instructions on how to properly handle the disposable set when opening the packaging in order to avoid damage.The guide also states that the user has to inspect the disposables cassette for damage and if damage is found, then the user is to ¿obtain a new disposable set¿ in order to avoid possible contamination of the fluid pathways.A review of the label for the product family will be conducted.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: 3884144
• MDR Text Key: 4542203
• Report Number: 1416980-2014-19470
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 05/25/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: R5C4479C
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/25/2014
• 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: HOMECHOICE
• Patient Age: 37 YR