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

Catalog Number R5C8320

Device Problem Device Inoperable (1663)

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

Event Date 05/13/2014

Event Type  malfunction  

Event Description

It was reported that an unknown malfunction occurred on a homechoice (hc) device during automated peritoneal dialysis (apd) therapy.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 reported problem was identified as a system error (se) 1006.The cause was determined to be the power supply, the power supply was scrapped and the device was sent for servicing.Should additional relevant information become available, a follow-up report will be submitted.

Manufacturer Narrative

(b)(4).The homechoice (hc) has been returned, and a device analysis is anticipated.Should additional relevant information become available, a supplemental report will be submitted.

Manufacturer Narrative

(b)(4).The device was returned to baxter and an evaluation was completed.A review of the event log was performed with no failures noted on the reported occurrence date.The following alarms were noted in the alarm log: system error 1006, low ultra filtration (uf) alarm, check heather line alarm, and check lines and bags alarm.A visual inspection was performed with no issues noted.Functional testing revealed that the power supply needed to be replaced.Additional functional testing, electrical safety testing, systems calibration, and a simulated therapy were performed with no additional failures or abnormalities identified.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: 3884598
• MDR Text Key: 4671817
• Report Number: 1416980-2014-19498
• Device Sequence Number: 1
• Product Code: FKX
• Combination Product (y/n): N
• Reporter Country Code: IT
• 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,Followup,Followup
• Report Date: 05/26/2014

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/19/2014
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Other
• Device Catalogue Number: R5C8320
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 05/26/2014
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 07/31/2014
• 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