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

Catalog Number L5C4531

Device Problems Component Falling (1105); Disconnection (1171); Unstable (1667); Device Displays Incorrect Message (2591)

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

Event Date 05/28/2014

Event Type  malfunction  

Event Description

It was reported that a system error (se) 2240 (air in set) alarm occurred on the homechoice machine during dwell four of five of peritoneal dialysis therapy.The patient was connected at the time of the alarm.During troubleshooting it was noted that the supply bag fell from an unstable surface and disconnected from the supply line.The patient was advised to start therapy over using new supplies.No patient injury or medical intervention was indicated as a result of this event.No additional information is available.

Manufacturer Narrative

(b)(4).The device was not returned and the lot number was unknown; therefore, a device analysis could not be completed.This is a report of a use error resulting in a system error 2240 alarm, where the home patient stated that the supply bag fell and disconnected from the supply line.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.Section ¿warnings and cautions¿ instructs the user to ¿place the solution bags on a flat, stable surface to prevent bags from falling.Fallings bags can result in a disconnect or leak.Possible contamination of the fluid or fluid pathways can result if a fluid leak occurs.¿ a formal review of the label for the product family will be conducted.Should additional relevant information become available, a follow-up 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: 3883695
• MDR Text Key: 4596227
• Report Number: 1416980-2014-19456
• 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: 05/28/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: L5C4531
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 05/28/2014
• 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: 82 YR