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U.S. Department of Health and Human Services

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

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BAXTER HEALTCARE-LARGO HOMECHOICE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY Back to Search Results
Catalog Number 5C4474
Device Problems Plug; Fire
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.

 
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Brand NameHOMECHOICE
Type of DeviceSYSTEM, 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 Key6125382
Report Number1416980-2016-17609
Device Sequence Number1
Product CodeFKX
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,CONSUM
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/19/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received11/23/2016
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device Catalogue Number5C4474
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer11/14/2016
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/09/2017
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

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