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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 Obstruction of Flow (2423); Material Deformation (2976); Protective Measures Problem (3015)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/14/2022
Event Type  malfunction  
Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that an unspecified infusion pump displayed an alarm ¿obstruction in the infusion flow¿ while being used with a continu-flo solution set. Upon further inspection, ¿it was observed that the valve of the faulty device had a protuberance on the upper part¿. This was observed during setup and preparation. There was no patient involvement. No additional information is available.
 
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Brand NameCONTINU-FLO SOLUTION SET
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
deerfield IL
Manufacturer (Section G)
BAXTER HEALTHCARE - TUNISIA
route de chebbaou
2021oued e
tunis
TS
Manufacturer Contact
25212 w. illinois route 120
round lake, IL 
2242702068
MDR Report Key15229851
MDR Text Key302084071
Report Number1416980-2022-04248
Device Sequence Number1
Product Code FPA
UDI-Device Identifier05413765578038
UDI-Public(01)05413765578038
Combination Product (y/n)N
Reporter Country CodeCO
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 09/19/2022
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received08/15/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberAMC9668
Device Lot Number21L10T990
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received09/09/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

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