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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE - CARTAGO CLEARLINK SOLUTION ADMINISTRATION SETS; SET, ADMINISTRATION, INTRAVASCULAR
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BAXTER HEALTHCARE - CARTAGO CLEARLINK SOLUTION ADMINISTRATION SETS; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number 2C8858
Device Problem Reflux within Device (1522)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
This event occurred during an unspecified date of (b)(6) 2019.(b)(4).Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that there was blood back up in the line of a paclitaxel set.The set was part of a set-up being used to deliver paclitaxel and nacl infusions to a patient with an infusion pump in the inpatient oncology.There was no report of patient injury or medical intervention associated with this event.No additional information is 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 SOLUTION ADMINISTRATION SETS
Type of Device
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
BAXTER HEALTHCARE - CARTAGO
cartago
MDR Report Key8422930
MDR Text Key138904160
Report Number1416980-2019-01414
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
PMA/PMN Number
K160007
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 04/16/2019
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received03/14/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number2C8858
Device Lot NumberASKU
Was Device Available for Evaluation? No
Date Manufacturer Received04/11/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
BBRAUN ONGUARD CTSD; CLEARLINK CONTINU-FLO SET; PACLITAXEL; SODIUM CHLORIDE (NACL); SPECTRUM PUMP
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