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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 Noise, Audible
Event Date 09/04/2015
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). Should additional relevant information become available, a supplemental report will be submitted.

 
Event Description

It was reported that a homechoice device emitted a 'pop' sound. The patient had turned the device off after therapy. When the customer switched the device back on, the device made a popping sound and would not power on. The technical services representative (tsr) 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 service history review revealed no indication that the parts replaced during servicing caused or contributed to the reported event. A visual inspection was performed with no issues noted. Full functional testing, electrical safety testing, calibration and simulated therapy were performed. The reported condition was confirmed during start up test. The cause of the condition was determined to be the power supply. The power supply was replaced to solve the issue. 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
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 Key5166441
Report Number1416980-2015-39677
Device Sequence Number1
Product CodeFKX
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Type of Report Initial,Followup
Report Date 11/12/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/21/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator NO INFORMATION
Device Catalogue NumberR5C8320
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer10/06/2015
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/10/2015
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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