MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Device Problems Misconnection (1399); Improper or Incorrect Procedure or Method (2017)

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

Event Date 04/11/2014

Event Type  malfunction  

Event Description

It was reported that the home patient (hp) had reused single-use supplies while they were performing peritoneal dialysis (pd) therapy on the homechoice (hc) device.The hp was connected in dwell 1 of 5.The hp stated that they connected the supply bag to the red clamp line and the heater bag to the white clamp line.The hp then swapped the bags around and contacted the technical service representative (tsr).The tsr confirmed that the hp was connected at the time of this event and explained that the setup was compromised.The tsr instructed to cycle the power on the hc to end the therapy.The tsr advised the hp to start over with all new supplies.There was no patient injury or medical intervention indicated at the time of the report.No additional information is available.

Manufacturer Narrative

(b)(4).As the device was not returned for analysis, no evaluation could be performed.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 not to replace empty solution bags or reconnect disconnected solution bags during therapy.It also warns the user that possible contamination of the fluid or fluid pathways can result if disposables are reused.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.

• Type of Device: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): BAXTER HEALTHCARE CORPORATION
• Manufacturer (Section G): BAXTER HEALTHCARE CORPORATION
• Manufacturer Contact: christina arnt ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242703198
• MDR Report Key: 3793979
• MDR Text Key: 4526538
• Report Number: 1416980-2014-14629
• Device Sequence Number: 1
• Product Code: FKX
• Combination Product (y/n): N
• Reporter Country Code: UK
• 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
• Report Date: 04/11/2014

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
• Was Device Available for Evaluation?: No
• Initial Date Manufacturer Received: 04/11/2014
• Initial Date FDA Received: 05/06/2014
• 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