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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 Device Displays Incorrect Message (2591)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that there was an issue with a paclitaxel set with a sigma spectrum infusion pump. This event occurred while the patient was connected for infusion. The tubing of the paclitaxel set was discovered to be rigid and the pump would alarm. There was no visible air in the line, and the line was primed without any issues. Additionally, the set flowed properly when not in the pump. The issue was resolved by switching to a different unspecified intravenous (iv) tubing set. There was no 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 NameCLEARLINK SOLUTION ADMINISTRATION SETS
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 Key7289273
MDR Text Key100720930
Report Number1416980-2018-00953
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K160007
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation Pharmacist
Type of Report Initial,Followup
Report Date 03/22/2018
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received02/22/2018
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number2C8858
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received03/13/2018
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

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