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U.S. Department of Health and Human Services

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

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BAXTER HEALTHCARE - LARGO HOMECHOICE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY Back to Search Results
Catalog Number 5C4471R
Device Problems Smoking; Noise, Audible
Event Date 02/05/2016
Event Type  Malfunction  
Manufacturer Narrative

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

 
Event Description

It was reported that there was a power failure with the homechoice (hc) during patient setup. The care giver turned the hc on and heard a popping noise, then saw smoke come from the hc. The technical service representative would swap the hc. There was patient involvement. There was no patient injury or medical intervention indicated at the time of the report. No additional information is available.

 
Manufacturer Narrative

(b)(4). The device was returned and the evaluation is complete. 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 issues were noted. The power harness connector is overheated at the accomp board side. The homechoice device received a returned instrument testing evaluation (rite). The device received rite functional and electrical testing. The device was received inoperative for no power, and then failed the power up verification step. The device passed the rite electrical test. Popping noise with smoke was verified by visual observation. The direct cause for popping noise with smoke was determined to be poor connection at the accomp board header to power harness interface connector j1 by inspection. The reported condition was verified. The product analysis lab has identified the entire device to be scrapped. 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 - 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 Key5432373
Report Number1416980-2016-03186
Device Sequence Number1
Product CodeFKX
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,CONSUM
Reporter Occupation
Type of Report Initial,Followup
Report Date 03/10/2016
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received02/11/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device Catalogue Number5C4471R
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer02/17/2016
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received02/26/2016
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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