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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 5C8310
Device Problem Temperature Problem
Event Date 10/05/2016
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 cycler overheated the solution bags during a fill cycle the patient was connected at the time of the event. The patient stated that the fluid was almost boiling hot and requested a new cycler. There was no report of patient injury or medical intervention associated with this event. No additional information is available.

 
Manufacturer Narrative

The homechoice device was returned and evaluated by the product analysis lab. 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. An internal/external inspection of the device was performed and passed. 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. A short simulated therapy was successfully performed. During evaluation no failure or malfunction that could have caused or contributed to the reported issue was found. 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 Key6054924
Report Number1416980-2016-16637
Device Sequence Number1
Product CodeFKX
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,CONSUM
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/01/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/25/2016
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 Manufacturer10/17/2016
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/28/2016
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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