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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE - CARTAGO CLEARLINK CONTINU-FLO SOLUTION SET SET, ADMINISTRATION, INTRAVASCULAR

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BAXTER HEALTHCARE - CARTAGO CLEARLINK CONTINU-FLO SOLUTION SET SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number 2C8519
Device Problem Product Quality Problem (1506)
Patient Problem No Patient Involvement (2645)
Event Type  malfunction  
Manufacturer Narrative
The device was received for evaluation. Visual inspection revealed that there was blue liquid inside the set. The liquid was further analyzed by liquid chromatography (lc) with ultraviolet-visual spectroscopy (uv-vis) and mass spectrometry (ms) and was found to contain methylene blue. This compound is commonly used in clinical settings as a dye or stain, and often added to saline or other iv solutions for infusion. Methylene blue is not used during the manufacture of this device. The cause of the condition could not be determined. A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot. Should additional relevant information become available, a supplemental report will be submitted.
 
Manufacturer Narrative
The event occurred sometime between (b)(6) 2017. (b)(6). Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that the tubing of a clearlink set appeared to be discolored. The reporter stated that the tubing was used with a sigma pump and it had turned blue. Dextrose 5% with 1/2 normal saline and 20meq potassium chloride was being infused. There was no patient injury or medical intervention associated with this event. No additional information is available.
 
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Brand NameCLEARLINK CONTINU-FLO SOLUTION SET
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
BAXTER HEALTHCARE - CARTAGO
cartago
Manufacturer (Section G)
BAXTER HEALTHCARE - CARTAGO
see h10
see h10
cartago 30106
CS 30106
Manufacturer Contact
25212 w. illinois route 120
round lake, IL 60073
2242702068
MDR Report Key6853573
MDR Text Key104360201
Report Number1416980-2017-07227
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 10/13/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received09/08/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number2C8519
Device Lot NumberASKU
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/08/2017
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/13/2017
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/28/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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