MAUDE Adverse Event Report: BAXTER HEALTHCARE - MOUNTAIN HOME; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Catalog Number ASKU

Device Problems Fluid/Blood Leak (1250); Improper or Incorrect Procedure or Method (2017); Tear, Rip or Hole in Device Packaging (2385)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/10/2016

Event Type  malfunction  

Manufacturer Narrative

This is a report of a use error where the final bag fell resulting in a tear in the tubing of a cassette.Use errors and proper user instructions are addressed in ¿the homechoice and homechoice pro systems patient at-home guide¿, which is shipped with every homechoice device.The guide instructs the user to place the solution bags on a flat, stable surface and that falling bags can result in a disconnection or leak.It also provides step-by-step instructions for connecting the solution bags.A review of the label for the product family will be conducted.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that a leak occurred on a homechoice cassette.This event occurred during dwell five of five while the patient was connected.The technical service representative (tsr) helped the registered nurse (rn) to end therapy early.The rn had come into the room to find the final bag hanging from the setup during dwell five of five with fluid all over the floor, and felt that the leak was caused by the bag falling and ripping the line to drain line.There was no patient injury or medical intervention associated with this event.No additional information is available.

• Brand Name: NI
• Type of Device: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): BAXTER HEALTHCARE - MOUNTAIN HOME; mountain home AR
• Manufacturer (Section G): BAXTER HEALTHCARE - MOUNTAIN HOME; 1900 n highway 201; mountain home AR 72653
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 6075600
• MDR Text Key: 59048746
• Report Number: 1416980-2016-16901
• Device Sequence Number: 1
• Product Code: FKX
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 11/03/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/03/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: ASKU
• Device Lot Number: ASKU
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 10/10/2016
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Treatment: HOMECHOICE