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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 Problem Noise, Audible
Event Date 10/08/2015
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). The device has been received and the evaluation is in progress. Upon completion of the investigation, or if any additional relevant information is received, a supplemental report will be submitted.

 
Event Description

It was reported that a homechoice device emitted a sparking noise. This was noted during prime of peritoneal dialysis. The patient stated that they could not see any visible signs of sparking but the deice was making a noise that sounded like a wire sparking. 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 homechoice device was returned to baxter healthcare for evaluation. A service history review was performed and did not reveal any previous service events that could have caused or contributed to the reported problem. An external and internal visual inspection revealed no issues. The device was tested and passed the return instrument test/evaluation (rite) electrical test and functional test. A simulated therapy was performed. During priming, the device made a loud sparking sound. The reported condition was verified. The cause of the issue was determined to be a noisy compressor. The device was sent to service with instructions to rework the compressor. A capa has been opened to address this issue. 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 Key5178482
Report Number1416980-2015-40088
Device Sequence Number1
Product CodeFKX
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,CONSUM
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/20/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received10/26/2015
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 Manufacturer10/16/2015
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/17/2015
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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