MAUDE Adverse Event Report: BAXTER HEALTHCARE - LARGO HOMECHOICE PRO; SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

Catalog Number R5C8320

Device Problems Device Inoperable (1663); Improper or Incorrect Procedure or Method (2017)

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

Event Date 04/24/2014

Event Type  malfunction  

Event Description

It was reported that the patient was having therapy problems and making user mistakes during peritoneal dialysis (pd) therapy on the homechoice (hc) pro machine.The specific issues and use errors were not reported.The step of setup or therapy during which this occurred was also not specified.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

(b)(4).The device was not returned; therefore, an evaluation could not be conducted.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.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 PRO
• Type of Device: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): BAXTER HEALTHCARE - LARGO; 7511 114th ave. north; largo FL 33773
• Manufacturer (Section G): BAXTER HEALTHCARE - LARGO; 7511 114th ave. north; largo FL 33773
• Manufacturer Contact: christina arnt ; 25212 w. illinois route 120; round lake, IL 60073 ; 2242703198
• MDR Report Key: 3819266
• MDR Text Key: 20297542
• Report Number: 1416980-2014-16165
• Device Sequence Number: 1
• Product Code: FKX
• Combination Product (y/n): N
• Reporter Country Code: NL
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Company Representative
• Reporter Occupation: Other
• Type of Report: Initial
• Report Date: 04/24/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/19/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: R5C8320
• Was Device Available for Evaluation?: No
• Date Manufacturer Received: 04/24/2014
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1