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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION CLEARLINK CONTINU-FLO BLOOD RECIPIENT SET; SET, BLOOD TRANSFUSION
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BAXTER HEALTHCARE CORPORATION CLEARLINK CONTINU-FLO BLOOD RECIPIENT SET; SET, BLOOD TRANSFUSION Back to Search Results
Catalog Number FNC3220N
Device Problem Fluid/Blood Leak (1250)
Patient Problem No Patient Involvement (2645)
Event Date 09/24/2020
Event Type  malfunction  
Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that a continu-flo blood/solution set leaked.The leak was observed from the clearlink side access port by the upper port close to the iv bag spike.The event occurred during priming.There was no patient involvement.No additional information is available.
 
Manufacturer Narrative
Correction made to d4: lot #: asku (previously submitted as 0000000).Additional information was added to h6.H10: 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.
 
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Brand Name
CLEARLINK CONTINU-FLO BLOOD RECIPIENT SET
Type of Device
SET, BLOOD TRANSFUSION
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
deerfield IL
MDR Report Key10715982
MDR Text Key212469384
Report Number1416980-2020-06547
Device Sequence Number1
Product Code BRZ
Combination Product (y/n)Y
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Type of Report Initial,Followup
Report Date 11/23/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue NumberFNC3220N
Device Lot Number0000000
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 09/24/2020
Initial Date FDA Received10/21/2020
Supplement Dates Manufacturer Received11/06/2020
Supplement Dates FDA Received11/24/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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