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

Catalog Number L5C4531

Device Problems Detachment Of Device Component (1104); Component Falling (1105); Improper or Incorrect Procedure or Method (2017)

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

Event Date 01/28/2014

Event Type  malfunction  

Event Description

It was reported that the patient line became disconnected during fill two on the home choice (hc).The home patient (hp) stated they had accidentally backed over the patient line and it came out while in fill 2.The technical service representative (tsr) advised the hp to stop therapy and assisted to end therapy.The tsr advised the hp to start over with new supplies.No patient injury or medical intervention was indicated as a result of this event.No additional information is available.

Manufacturer Narrative

(b)(4).The device was not returned and the lot number was unknown; therefore, a device analysis could not be completed.This complaint is for a report of a connection issue during fill two where the home patient had backed over the patient line, disconnecting the line.Use errors and 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 patient guide provides step-by-step instructions for properly disconnecting during emergencies.The patient guide provides step-by-step instructions for ending therapy.A formal review of the label for the product family will be conducted.Should additional relevant information become available, a follow-up 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: 3640443
• MDR Text Key: 4352755
• Report Number: 1416980-2014-06252
• 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,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 01/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 02/21/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: L5C4531
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 01/28/2014
• 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: 66 YR