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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE - MOUNTAIN HOME CAPD DISCONNECT Y SET SYSTEM, PERITONEAL, AUTOMATIC DELIVERY

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BAXTER HEALTHCARE - MOUNTAIN HOME CAPD DISCONNECT Y SET SYSTEM, PERITONEAL, AUTOMATIC DELIVERY Back to Search Results
Catalog Number JIC8328
Device Problem Misconnection
Event Date 07/24/2015
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 the y-set did not connect properly to the transsfer set using a uv assist device. There was no patient injury or medical intervention reported. No additional information is available.

 
Manufacturer Narrative

(b)(4). The device was received for evaluation. Visual and microscopic inspection did not identify any abnormalities that could have contributed to the reported condition. Functional testing of the device included leak testing, clear passage testing, clamp function testing and device-device interaction testing; no issues were observed that could have caused or contributed to the reported issue. A batch review was conducted and there were no deviations found related to this condition during the manufacture of this lot. The reported issue was not verified. Should additional relevant information become available, a supplemental report will be submitted.

 
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Brand NameCAPD DISCONNECT Y SET
Type of DeviceSYSTEM, PERITONEAL, AUTOMATIC DELIVERY
Manufacturer (Section D)
BAXTER HEALTHCARE - MOUNTAIN HOME
1900 n highway 201
mountain home AR 72653
Manufacturer (Section G)
BAXTER HEALTHCARE - MOUNTAIN HOME
1900 n highway 201
mountain home AR 72653
Manufacturer Contact
kinga almasan
25212 w. illinois route 120
round lake , IL 60073
2242702068
MDR Report Key5002101
Report Number1416980-2015-32340
Device Sequence Number1
Product CodeFKX
Report Source Manufacturer
Source Type COMPANY REPRESENTATIVE,FOREIG
Reporter Occupation
Type of Report Initial,Followup
Report Date 09/25/2015
1 Device Was Involved in the Event
0 PatientS WERE Involved in the Event:
Date FDA Received08/13/2015
Is This An Adverse Event Report? No
Is This A Product Problem Report? Yes
Device Operator LAY USER/PATIENT
Device Catalogue NumberJIC8328
Device LOT NumberH15B19074
Was Device Available For Evaluation? Device Returned To Manufacturer
Date Returned to Manufacturer08/07/2015
Is The Reporter A Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received09/20/2015
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 Unkown

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