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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION CLEARLINK DUO-VENT SECONDARY MEDICATION SET SET, ADMINISTRATION, INTRAVASCULAR

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BAXTER HEALTHCARE CORPORATION CLEARLINK DUO-VENT SECONDARY MEDICATION SET SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number 2H7462
Device Problem Reflux within Device (1522)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/31/2020
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported a clearlink system non-dehp secondary medication set back flowed. It was further reported that the event occurred during patient infusion. The secondary set was connected to a secondary administration bag filled with methylene dye in 100ml 5% dextrose and ¿through the backcheck value¿ which is connected to a 1000ml viaflex bag. ¿to prevent to medication from back flowing into the primary bag we clamped the primary line once this issue was discovered¿. There was no patient injury or medical intervention associated with this event. No additional information is available.
 
Manufacturer Narrative
Additional information was added: the device was received for evaluation. Visual inspection did not identify any abnormalities that could have contributed to the reported condition. Pressure testing and clear passage under water testing were performed with no issues noted. The set was primed, and backflow functional testing was performed. The device primed normally and worked per specification with no backflow noted. The reported condition was not verified. Should additional relevant information become available, a supplemental report will be submitted.
 
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Brand NameCLEARLINK DUO-VENT SECONDARY MEDICATION SET
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
deerfield IL
Manufacturer (Section G)
BAXTER HEALTHCARE - CARTAGO
see h10
cartago 30106
CS 30106
Manufacturer Contact
25212 w. illinois route 120
round lake, IL 60073
2242702068
MDR Report Key9781509
MDR Text Key181815912
Report Number1416980-2020-01145
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,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 04/02/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/03/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number2H7462
Device Lot NumberASKU
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer03/12/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/21/2020
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 Unkown

Patient Treatment Data
Date Received: 03/03/2020 Patient Sequence Number: 1
Treatment
1000ML 0.9% SODIUM CHLORIDE; 1000ML VIAFLEX BAG; 5% 100ML IV MINI BAG; 5% DEXTROSE 100 ML; METHYLENE BLUE DYE; UNKNOWN ADMINISTRATIVE SET
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