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

Catalog Number R5C4479C

Device Problems Device Displays Incorrect Message (2591); Human-Device Interface Problem (2949)

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

Event Date 03/06/2014

Event Type  malfunction  

Event Description

It was reported that a homechoice device experienced a system error 2240 (air in tubing).The home patient (hp) was connected at the time of the alarm.This occurred during drain three of five of peritoneal dialysis (pd) therapy.The caregiver stated that the home patient twisted his transfer set to close it and somehow cut the patient line tubing.There was no patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

(b)(4).An alarm indicative of a potential malfunction of the disposable cassette was identified.The device was not available for evaluation.If additional relevant information becomes available, a supplemental report will be submitted.

Manufacturer Narrative

(b)(4).The caregiver stated that the home patient twisted the transfer set to close it and somehow cut the patient line tubing.The use of damaged supplies is a known cause of this alarm.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 follow aseptic technique taught by the dialysis center when handling lines and solution bags to reduce the possibility of infection.The guide also warns the user that using damaged sets can result in contamination of the fluid or fluid pathways.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: 3714347
• MDR Text Key: 4268877
• Report Number: 1416980-2014-10385
• 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: 03/06/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/31/2014
• 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: 04/23/2014
• 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
• Patient Age: 69 YR