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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION CLEARLINK CONTINU-FLO SOLUTION SET
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BAXTER HEALTHCARE CORPORATION CLEARLINK CONTINU-FLO SOLUTION SET Back to Search Results
Catalog Number 2H8519
Medical Device Problem Code Failure to Prime (1492)
Health Effect - Clinical Code No Patient Involvement (2645)
Date of Event 06/28/2020
Type of Reportable Event Malfunction
Additional Manufacturer Narrative
(b)(4).Should additional relevant information become available, a supplemental report will be submitted.
 
Event or Problem Description
It was reported that a clearlink system non-dehp continu-flo solution set would not prime.This issue was identified during priming prior to use.There was no patient involvement.No additional information is available.
 
Additional Manufacturer Narrative
H10: 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.
 
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Brand Name
CLEARLINK CONTINU-FLO SOLUTION SET
Common Device Name
CLEARLINK CONTINU-FLO SOLUTION SET
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
deerfield IL
MDR Report Key10317058
Report Number1416980-2020-04261
Device Sequence Number991580
Product Code FPA
UDI-Device Identifier00085412048451
UDI-Public(01)00085412048451
Combination Product (Y/N)Y
Initial Reporter CountryCO
PMA/510(K) Number
K961225
Number of Events Summarized1
Summary Report (Y/N)N
Reporter Type Manufacturer
Report Source company representative,foreig
Initial Reporter Occupation Pharmacist
Type of Report Initial,Followup
Report Date (Section B) 08/25/2020
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
Operator of Device Other
Device Catalogue Number2H8519
Device Lot NumberR20B05027
Was Device Available for Evaluation? No
Initial Date Received by Manufacturer 06/30/2020
Supplement Date Received by Manufacturer08/07/2020
Initial Report FDA Received Date07/23/2020
Supplement Report FDA Received Date08/25/2020
Is This a Single-Use Device that was
Reprocessed and Reused on a Patient? (Y/N)		 No
Patient Sequence Number1
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