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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 2R8537
Device Problems Reflux within Device (1522); No Flow (2991)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 05/29/2019
Event Type  malfunction  
Manufacturer Narrative
(b)(6).Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that a backflow of medication occurred within a primary clearlink system continu-flo solution set.A secondary medication line was setup to infuse potassium to a patient through the primary set; however, after starting the infusion, it was observed that the medication was not delivered to the patient, but back flowed into the drip chamber of the primary set.There was no patient injury or medical intervention associated with this event.No additional information was available.
 
Manufacturer Narrative
The device was not returned and the lot number is unknown; 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
Type of Device
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
BAXTER HEALTHCARE - CARTAGO
cartago
MDR Report Key8732368
MDR Text Key149157250
Report Number1416980-2019-03449
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
PMA/PMN Number
K961225
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 07/26/2019
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 Other
Device Catalogue Number2R8537
Device Lot NumberASKU
Was Device Available for Evaluation? No
Initial Date Manufacturer Received 05/29/2019
Initial Date FDA Received06/25/2019
Supplement Dates Manufacturer Received07/23/2019
Supplement Dates FDA Received07/26/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
CLEARLINK SYSTEM NON-DEHP SECONDARY MEDICATION SET; POTASSIUM
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