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

Catalog Number 5C8310R

Device Problems No Display/Image (1183); Device Displays Incorrect Message (2591)

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

Event Date 05/03/2014

Event Type  malfunction  

Event Description

It was reported that an unknown audible alarm occurred on a homechoice (hc) device.The alarm occurred while the home patient (hp) was cycling the power to troubleshoot a display issue.The specific alarm was unable to be determined as the display was not functioning.A technical service representative (tsr) initiated a swap of the device.The hp planned on calling a peritoneal dialysis registered nurse (pdrn) to inform them of the issue.There was no patient injury or medical intervention indicated at the time of the report.No additional information is available.

Manufacturer Narrative

(b)(4).The homechoice (hc) has been reported to be available for evaluation but has not yet been received.If the sample is received or additional relevant information becomes available, a supplemental report will be submitted.

Manufacturer Narrative

(b)(4).The device was returned and an evaluation was performed to investigate the reported event of other alarm.During visual inspection, no issues were found.The power on self-test and one hour therapy test were not performed successfully and event history was not downloaded because of alarm with no display.Upon conclusion of the investigation, the reported problem of other alarm was verified and the cause for the reported problem was due to defective digital printed circuit board (pcb).The digital pcb was replaced.Should additional relevant information become available, a follow-up 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: 3836083
• MDR Text Key: 4410298
• Report Number: 1416980-2014-17197
• 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
• Report Date: 05/03/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/28/2014
• 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: 05/09/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 10/28/2014
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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