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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 L5C4531
Device Problems Tube; Bent; Melted
Event Date 11/29/2016
Event Type  Malfunction  
Manufacturer Narrative

(b)(4). The device has been received and the evaluation is in progress. Should additional relevant information become available, a supplemental report will be submitted.

 
Event Description

It was reported that the homechoice cassette had tubing that connects to the patient line which appeared to be ¿melted and caved in¿. This was noted during the set up for peritoneal dialysis therapy. The patient re-set up with new supplies. There was no patient injury or medical intervention associated with this event. No additional information is available.

 
Manufacturer Narrative

The device was received for evaluation with an open pouch; an evaluation is complete. A batch review was conducted and there were no deviations found related to the reported condition during the manufacture of this lot. A visual inspection was performed with the naked eye. Functional testing was performed which included leak testing, clear passage testing, clamp function testing, and device-device interaction testing. The reported problem damaged was not verified because visual inspection was performed with no issues. The cause was undetermined. Should additional relevant information become available, a supplemental report will be submitted.

 
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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 Key6200131
Report Number1416980-2016-18675
Device Sequence Number1
Product CodeFKX
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,CONSUM
Reporter Occupation
Type of Report Initial,Followup
Report Date 02/01/2017
1 Device Was Involved in the Event
1 Patient Was Involved in the Event
Date FDA Received12/22/2016
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device Catalogue NumberL5C4531
Device LOT NumberH16I13014
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer12/16/2016
Is The Reporter A Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/09/2017
Was Device Evaluated By Manufacturer? Yes
Is The Device Single Use? Yes
Is this a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient TREATMENT DATA
Date Received: 12/22/2016 Patient Sequence Number: 1
Treatment
HOMECHOICE
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