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U.S. Department of Health and Human Services

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

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BAXTER HEALTHCARE- SINGAPORE HOMECHOICE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY Back to Search Results
Catalog Number 5C4471
Device Problems Plug; Break
Event Date 10/27/2016
Event Type  Malfunction  
Manufacturer Narrative

Should additional relevant information become available, a supplemental report will be submitted.

 
Event Description

It was reported that a homechoice device presented a damaged cable. There was no report of patient injury or medical intervention associated with this event. No additional information is available.

 
Manufacturer Narrative

A service history review revealed no indication that the parts replaced during servicing caused or contributed to the reported event. The device was not returned for analysis; therefore, no evaluation could be performed. Should additional relevant information become available, a supplemental report will be submitted.

 
Manufacturer Narrative

The device was returned and evaluated. Method codes had additional method codes added, but conclusion code was replaced and results code was replaced. The device was received for evaluation. Visual inspection was performed and no issues were noted. The device passed all functional testing. The event history log review showed no keystrokes, programming, or use related events that indicated and/or contributed to the reported issue. The reported problem of a damaged power cord was not verified during the device evaluation. 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 HEALTHCARE- SINGAPORE
singapore
Manufacturer (Section G)
BAXTER HEALTHCARE-SINGAPORE
2 woodlands industrial
singapore 73875 0
SN  738750
Manufacturer Contact
25212 w. illinois route 120
round lake , IL 60073
2242702068
MDR Report Key6126031
Report Number1416980-2016-17607
Device Sequence Number1
Product CodeFKX
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup,Followup
Report Date 03/22/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received11/23/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator OTHER
Device Catalogue Number5C4471
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer01/05/2017
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/21/2017
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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