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

Catalog Number 5C4474

Device Problem Fire (1245)

Patient Problem No Consequences Or Impact To Patient (2199)

Event Date 10/28/2016

Event Type  malfunction  

Manufacturer Narrative

The device has been received and the evaluation is in progress.Should additional relevant information become available, a supplemental report will be submitted.

Event Description

It was reported that the plug of a homechoice device set on fire (from the side of the plug that was connected to the device).The patient was connected at the time of the event.There was no patient injury or medical intervention associated with this event.No additional information is available.

Manufacturer Narrative

The device was received for evaluation and an evaluation is complete.A service history review revealed no indication that the parts replaced during servicing caused or contributed to the reported event.The event history log review showed no keystrokes, programming, or use related events that indicated and/or contributed to the reported issue.A visual inspection was performed.Full functional testing, electrical safety testing, calibration and simulated therapy were performed.Initial part of the power cord that enters to the device and the power inlet module was burnt.The sample analysis revealed that the power input fuses were blown, which is an expected device response to an electrical short.The reported condition was verified.No hardware problems were found that could have caused or contributed to the event.The power inlet module and power cord were changed because of the burnt.No damaged was found inside the device.The power supply unit and ac power cable assembly were replaced as proactively.The cause was undetermined.Should additional relevant information become available, a supplemental report will be submitted.

• Brand Name: HOMECHOICE
• Type of Device: SYSTEM, PERITONEAL, AUTOMATIC DELIVERY
• Manufacturer (Section D): BAXTER HEALTCARE-LARGO; largo FL
• Manufacturer (Section G): BAXTER HEALTHCARE - LARGO; 7511 114th ave. north; largo FL 33773
• Manufacturer Contact: 25212 w. illinois route 120; round lake, IL 60073 ; 2242702068
• MDR Report Key: 6125382
• MDR Text Key: 60800252
• Report Number: 1416980-2016-17609
• Device Sequence Number: 1
• Product Code: FKX
• Combination Product (y/n): N
• Reporter Country Code: TU
• PMA/PMN Number: NA
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,consum
• Reporter Occupation: Other
• Type of Report: Initial,Followup
• Report Date: 01/19/2017

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 11/23/2016
• Is this a Product Problem Report?: Yes
• Device Operator: Lay User/Patient
• Device Catalogue Number: 5C4474
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 11/14/2016
• Is the Reporter a Health Professional?: No
• Date Manufacturer Received: 01/09/2017
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1