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

Catalog Number L5C4531

Device Problems Disconnection (1171); Filling Problem (1233); Improper or Incorrect Procedure or Method (2017); Device Displays Incorrect Message (2591)

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

Event Date 03/13/2014

Event Type  malfunction  

Event Description

It was reported that a system error (se) 2240 (air in set) alarm occurred during fill four of four on the home choice (hc).The home patient (hp) was connected at the time of the event.The hp indicated during troubleshooting that they had disconnected prior to the alarm and had reconnected without using proper procedures.The technical service representative (tsr) assisted the hp to clear the alarm and the hp disconnected.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.Per ¿the homechoice and homechoice pro apd systems patient at-home guide¿, users are not instructed to disconnect during therapy unless for an emergency disconnect procedure.The patient guide provides step-by-step instructions for returning to therapy after the emergency disconnect procedure.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: 3731319
• MDR Text Key: 4329393
• Report Number: 1416980-2014-11292
• 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
• Report Date: 03/13/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• 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
• Initial Date Manufacturer Received: 03/13/2014
• Initial Date FDA Received: 04/07/2014
• 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: 77 YR