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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION CONTINU-FLO SOLUTION SET; SET, ADMINISTRATION, INTRAVASCULAR
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BAXTER HEALTHCARE CORPORATION CONTINU-FLO SOLUTION SET; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number AMC9668
Device Problems Failure to Prime (1492); Obstruction of Flow (2423)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 03/05/2021
Event Type  malfunction  
Manufacturer Narrative
Initial reporter phone no.- (b)(6).Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that there was a blockage within a continu-flo solution set which resulted in a failure to prime the set.This issue was observed during priming prior to patient use.There was no patient involvement.No additional information is available.
 
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.
 
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Brand Name
CONTINU-FLO SOLUTION SET
Type of Device
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
deerfield IL
MDR Report Key11608391
MDR Text Key244001658
Report Number1416980-2021-01832
Device Sequence Number1
Product Code FPA
UDI-Device Identifier05413765578038
UDI-Public(01)05413765578038
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 05/07/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received04/02/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue NumberAMC9668
Device Lot Number20G27T053
Was Device Available for Evaluation? No
Date Manufacturer Received05/06/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
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