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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 R5C8320
Device Problem Temperature Problem
Event Date 07/07/2017
Event Type  Malfunction  
Manufacturer Narrative

(b)(6). Should additional relevant information become available, a supplemental report will be submitted.

 
Event Description

It was reported that a homechoice pro device was over warming the solution. There was no report of patient injury or medical intervention associated with this event. No additional information is available.

 
Manufacturer Narrative

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 service history review revealed no indication that the parts replaced during servicing caused or contributed to the reported event. Internal and external inspection was performed and no issues were noted. Full functional testing, electrical safety testing, calibration, and a short simulated therapy were successfully performed. The reported condition was not verified. 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 - 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 Key6754404
Report Number1416980-2017-06254
Device Sequence Number1
Product CodeFKX
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,CONSUM
Reporter Occupation
Type of Report Initial
Report Date 09/05/2017
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received07/31/2017
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator OTHER
Device Catalogue NumberR5C8320
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer07/18/2017
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/31/2017
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 Reuse

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