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

Device Problem Improper or Incorrect Procedure or Method (2017)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 04/25/2016

Event Type  malfunction  

Manufacturer Narrative

(b)(4).This is a report of use error where a patient replaced a solution bag during therapy.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 not to attempt to reuse any disposable supplies.It warns the user not to replace empty solution bags or reconnect disconnected solution bags during therapy.Also, it warns the user that possible contamination of the fluid or fluid pathways can result if disposables are reused.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 patient reused single-use supplies during fill three of four of peritoneal dialysis therapy.The patient was connected at the time of the event.The patient replaced the heater bag during therapy.The technical service representative assisted with ending therapy.There was no patient injury or medical intervention associated with this event.No additional information is available.

• 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: kinga almasan ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 5667984
• MDR Text Key: 45574980
• Report Number: 1416980-2016-09438
• Device Sequence Number: 1
• Product Code: FKK
• Combination Product (y/n): N
• Reporter Country Code: US
• 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: 05/19/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2016
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/25/2016
• 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
• Patient Age: 61 YR