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U.S. Department of Health and Human Services

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

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BAXTER HEALTHCARE - LARGO HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY Back to Search Results
Catalog Number 5C8310R
Device Problems Power Cord; Plug; Overheating of Device
Event Date 11/07/2015
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). The device was not returned and an evaluation could not be completed. A service history review revealed no indication that the parts replaced during servicing caused or contributed to the reported event. Should additional relevant information become available, a supplemental report will be submitted.

 
Event Description

It was reported that the plug of a homechoice power cord was burnt and blackened. It was also reported that part of the power cord looked like it had overheated and was able to crumble. The patient reported that there was no power failure. When the patient removed the plug from the wall, the outlet was blackened. This was discovered after therapy was successfully completed. During follow up, the patient reported that they had no further issues after the power cord was replaced. There was no patient injury or medical intervention associated with this event. No additional information is available.

 
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Brand NameHOMECHOICE PRO
Type of DeviceSYSTEM, 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
kinga almasan
25212 w. illinois route 120
round lake , IL 60073
2242702068
MDR Report Key5257566
Report Number1416980-2015-43016
Device Sequence Number1
Product CodeFKX
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,CONSUM
Reporter Occupation
Type of Report Initial
Report Date 12/01/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received12/01/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device Catalogue Number5C8310R
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/07/2015
Was Device Evaluated By Manufacturer? No Answer Provided
Is The Device Single Use? No
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Reuse

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