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

Catalog Number R5C4479C

Device Problems Device Inoperable (1663); Device Displays Incorrect Message (2591)

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

Event Type  malfunction  

Manufacturer Narrative

(b)(4).A review of all batch record documents was performed for lot number h14a29050 with no issues noted during the manufacturing process.There were no deviations from standard procedure and no exceptions related to the reported condition noted.As the device was not returned for analysis, an evaluation could not be performed.It was reported that the patient reused single use supplies.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 instructs the user not to attempt to reuse any disposable supplies and warns the user not to replace empty solution bags or reconnect disconnected solution bags during therapy.It also warns the user that possible contamination of the fluid or fluid pathways can result if disposables are reused.A formal review of the label for the product family will be conducted.If additional relevant information is obtained, then a follow-up mdr will be submitted.

Event Description

It was reported that a home patient (hp) swapped out the cassette only in an attempt to clear a check lines and bags alarm during therapy on the homechoice.The patient was not connected at the time of the alarm.The hp stated that the alarm ¿went away¿ after they changed out the cassette.The hp then attached a new cassette and proceeded to continue therapy.There was no patient injury or medical intervention indicated at the time of the report.No additional information is available.This is report 6 of 7.

Manufacturer Narrative

(b)(4).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: 3816359
• MDR Text Key: 12307753
• Report Number: 1416980-2014-15879
• 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,Followup
• Report Date: 04/23/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/16/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Expiration Date: 01/31/2019
• Device Catalogue Number: R5C4479C
• Device Lot Number: H14A29050
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/14/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 01/29/2014
• 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