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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE - MOUNTAIN HOME HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

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BAXTER HEALTHCARE - MOUNTAIN HOME HOMECHOICE AUTOMATED PD SET WITH CASSETTE SYSTEM, PERITONEAL, AUTOMATIC DELIVERY Back to Search Results
Catalog Number R5C4479C
Device Problems Fluid Leak; Material Perforation
Event Type  Malfunction  
Manufacturer Narrative

Event date was on an unspecified date in (b)(6) 2018. The device was not returned and the lot number is unknown; therefore, a device analysis could not be completed. Should additional relevant information become available, a supplemental report will be submitted.

 
Event Description

It was reported that a homechoice cassette had a pin hole and there was a 'little leak'. There was no patient injury or medical intervention associated with this event. No additional information is available.

 
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Brand NameHOMECHOICE AUTOMATED PD SET WITH CASSETTE
Type of DeviceSYSTEM, PERITONEAL, AUTOMATIC DELIVERY
Manufacturer (Section D)
BAXTER HEALTHCARE - MOUNTAIN HOME
mountain home AR
Manufacturer (Section G)
BAXTER HEALTHCARE - MOUNTAIN HOME
1900 n highway 201
mountain home AR 72653
Manufacturer Contact
25212 w. illinois route 120
round lake , IL 60073
2242702068
MDR Report Key8064712
Report Number1416980-2018-07197
Device Sequence Number1
Product CodeFKX
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,CONSUM
Reporter Occupation
Type of Report Initial
Report Date 11/13/2018
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received11/13/2018
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device Catalogue NumberR5C4479C
Device LOT NumberASKU
Was Device Available For Evaluation? No
Is The Reporter A Health Professional?
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/19/2018
Was Device Evaluated By Manufacturer? Device Not Returned To Manufacturer
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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