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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE - SINGAPORE CLEARLINK CONTINU-FLO BLOOD RECIPIENT SET; SET, BLOOD TRANSFUSION

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BAXTER HEALTHCARE - SINGAPORE CLEARLINK CONTINU-FLO BLOOD RECIPIENT SET; SET, BLOOD TRANSFUSION Back to Search Results
Catalog Number FNC3220
Device Problem No Flow (2991)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 08/20/2018
Event Type  malfunction  
Manufacturer Narrative
A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.The device was not received for evaluation; therefore, a device analysis could not be completed.Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that there was no flow through the valve on the distal end of a clearlink system continu-flo blood/solution infusion set.Once the line was primed and connected to the patient, the anesthetist attempted to inject some anesthetic agents through the valve closest to the patient.Despite the syringe being well connected nothing would go through the valve.The alternate valve was used and was working normally.There was no patient injury or medical intervention associated with this event.No additional information is available.
 
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Brand Name
CLEARLINK CONTINU-FLO BLOOD RECIPIENT SET
Type of Device
SET, BLOOD TRANSFUSION
Manufacturer (Section D)
BAXTER HEALTHCARE - SINGAPORE
singapore
Manufacturer (Section G)
BAXTER HEALTHCARE - SINGAPORE
2 woodlands industrial park d
singapore 73875 0
SN   738750
Manufacturer Contact
25212 w. illinois route 120
round lake, IL 60073
2242702068
MDR Report Key7884882
MDR Text Key120542287
Report Number1416980-2018-05984
Device Sequence Number1
Product Code BRZ
UDI-Device Identifier00085412091990
UDI-Public(01)00085412091990
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Other
Type of Report Initial
Report Date 09/18/2018
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 Health Professional
Device Expiration Date01/31/2023
Device Catalogue NumberFNC3220
Device Lot NumberSR18B25073
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 08/21/2018
Initial Date FDA Received09/18/2018
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 N
Patient Sequence Number1
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