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U.S. Department of Health and Human Services

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

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BAXTER HEALTHCARE - SINGAPORE HOMECHOICE PRO SYSTEM, PERITONEAL, AUTOMATIC DELIVERY Back to Search Results
Catalog Number 5C8310
Device Problems Plug; Overheating of Device
Event Date 03/10/2016
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). The device has been received and the evaluation is in progress. Upon completion of the investigation, or if any additional relevant information is received, a supplemental report will be submitted.

 
Event Description

It was reported that the plug of the power cord was damaged duing peritoneal dialysis on the homechoice. The customer stated that the cord was damaged at the outlet and one prong looked burnt. The technical services representative arranged a swap and discussed the use of manual supplies to complete therapy until the new device arrives. There was no patient injury or medical intervention reported. No additional information is available.

 
Manufacturer Narrative

(b)(4). The device was received for evaluation. The event history log review showed no keystrokes, programming, or use related events that indicated and/or contributed to the reported issue. A device history review revealed no issues that could have caused or contributed to the reported issue. Internal and external inspection was performed and a burned prong on the power cord was observed. The hot lead tang on the wall outlet side of the cord had a spot that showed signs of electrical arcing. The surface of the metal is discolored from overheating, and the plastic around it is melted. The homechoice device received a returned instrument testing evaluation (rite). This evaluation included functional and electrical testing of the device. The device was determined to meet functional and electrical performance specification requirements per rite testing. The reported issue was verified by visual observation. The direct cause of the problem was a situational bad connection at the wall outlet. The cord was replaced. Should additional relevant information become available, a supplemental report will be submitted.

 
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Brand NameHOMECHOICE PRO
Type of DeviceSYSTEM, PERITONEAL, AUTOMATIC DELIVERY
Manufacturer (Section D)
BAXTER HEALTHCARE - SINGAPORE
2 woodlands industrial park
singapore 2573
SN  2573
Manufacturer (Section G)
BAXTER HEALTHCARE - SINGAPORE
2 woodlands industrial park
singapore 2573
SN  2573
Manufacturer Contact
kinga almasan
25212 w. illinois route 120
round lake , IL 60073
2242702068
MDR Report Key5545610
Report Number1416980-2016-06493
Device Sequence Number1
Product CodeFKX
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,CONSUM
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/29/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received04/04/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device Catalogue Number5C8310
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer03/18/2016
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received04/08/2016
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

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