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 05/18/2014

Event Type  malfunction  

Event Description

It was reported that a solution bag fell and became disconnected from an automated pd set with cassette.This occurred during dwell one of five of peritoneal dialysis (pd) therapy, while the home patient (hp) was not connected.The technical service representative (tsr) assisted the hp in ending therapy so they could start therapy over using new supplies.There was no patient injury or medical intervention associated with 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.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 guide warns the user to place the solution bags on a flat, stable surface.A formal review of the label for the product family will be conducted.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: 3857191
• MDR Text Key: 4455786
• Report Number: 1416980-2014-18426
• Device Sequence Number: 1
• Product Code: FKX
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K102936
• 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: 05/18/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/09/2014
• 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
• Date Manufacturer Received: 05/18/2014
• 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: 79 YR