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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CLEARLINK DUO-VENT CONTINU-FLO SOLUTION SET SET, ADMINISTRATION, INTRAVASCULAR

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BAXTER HEALTHCARE CLEARLINK DUO-VENT CONTINU-FLO SOLUTION SET SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number 2C8541
Device Problems Fluid Leak (1250); Cut In Material (2454)
Patient Problem No Patient Involvement (2645)
Event Date 06/13/2016
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that clearlink continu-flo solution set leaked when the blue key clamp was removed. The set was filled with saline solution and was being used with a pump. The leak was found during priming. There was no patient involvement. No additional information is available.
 
Manufacturer Narrative
(b)(4). The device was received for evaluation. Visual inspection revealed a cut/hole in the tubing approximately 18 inches below the top y site. The reported condition was verified. The cause of the condition was determined to be a human production issue. Should additional relevant information become available, a supplemental report will be submitted.
 
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Brand NameCLEARLINK DUO-VENT CONTINU-FLO SOLUTION SET
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
BAXTER HEALTHCARE
600 mts oeste de entrada
cartago
CS
Manufacturer (Section G)
BAXTER HEALTHCARE
600 mts oeste de entrada
cartago
CS
Manufacturer Contact
kinga almasan
25212 w. illinois route 120
round lake, IL 60073
2242702068
MDR Report Key5773532
MDR Text Key48919343
Report Number1416980-2016-11589
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K961225
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,other
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/08/2016
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received07/06/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number2C8541
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer07/06/2016
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received07/21/2016
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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