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

Catalog Number 5C8310R

Device Problem Device Inoperable (1663)

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

Event Date 04/22/2014

Event Type  malfunction  

Event Description

It was reported that a homechoice (hc) pro machine ¿was not working properly¿.This occurred during an unknown step of peritoneal dialysis (pd) therapy, while the patient was connected.There was no report of patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

(b)(4).A request for the return of the device has been made.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

(b)(4).The device was received for evaluation.A review of the event log could not identify the reported problem.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.Functional testing and a simulated therapy were performed, and no issues related to the reported condition were noted.The device passed all check and calibration tests.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

(b)(4).The patient clarified that by their previous report of the homechoice (hc) being ¿defective¿.They reported that the hc was draining less than when they are doing non-automated peritoneal dialysis (pd) therapy.The patient completed the pd therapy manually and there was no change to their dialysis prescription.The patient received a different hc device and they were no longer having any draining issues.Additional information/correction to the results of the evaluation: the event history log review verified the reported event of draining difficulty because a low drain volume alarm was found to have occurred on the date of this event.The device history record review revealed no issues that could have caused or contributed to the reported difficulty.The evaluation of the device could not duplicate the reported event and the cause could not be determined.The cause of the reported issue could not be determined.If additional relevant information is obtained, then a follow-up mdr 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: 3813740
• MDR Text Key: 4523751
• Report Number: 1416980-2014-15642
• Device Sequence Number: 1
• Product Code: FKX
• Combination Product (y/n): N
• Reporter Country Code: CA
• PMA/PMN Number: K102936
• 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,Followup,Followup
• Report Date: 04/22/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/15/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 5C8310R
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/06/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/07/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Date Device Manufactured: 03/06/2006
• 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