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

Catalog Number R5C4479C

Device Problems Component Falling (1105); Disconnection (1171)

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

Event Date 03/17/2014

Event Type  malfunction  

Event Description

It was reported that a bag fell and disconnected from the cassette line during the dwell phase on the home choice (hc).The home patient (hp) stated she stopped the dwell cycle and disconnected herself.The technical service representative (tsr) assisted the hp to end therapy.No patient injury or medical intervention was indicated as a result of this event.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.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

(b)(4).This is a report of a supply bag that fell and disconnected from the lined.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 to place the solution bags on a flat, stable surface and it warns that falling bags can result in a disconnection or leak.The guide also instructs the user to check all disposable set connections for a secure fit before beginning therapy and provides step-by-step instructions for connecting the solution bags.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.

• 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: 3733693
• MDR Text Key: 4271333
• Report Number: 1416980-2014-11428
• Device Sequence Number: 1
• Product Code: FKX
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K923065
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Consumer,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 03/17/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 04/08/2014
• 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
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/07/2014
• 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: Unknown
• Patient Sequence Number: 1
• Treatment: HOMECHOICE