• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

BAXTER HEALTHCARE - CARTAGO CLEARLINK CONTINU-FLO SOLUTION SET SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number 2C8519
Device Problems Detachment Of Device Component (1104); Fluid Leak (1250); Cut In Material (2454)
Patient Problem No Patient Involvement (2645)
Event Date 04/30/2017
Event Type  malfunction  
Manufacturer Narrative
(b)(4). (b)(6). Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported a clearlink system continu-flo solution set leaked. During priming with magnesium (1g in 100ml), the tubing had separated between the tubing and the y-site most proximal to the patient and the medication leaked out. It was reported the ¿tubing looked like it had been cut with a sharp object¿. The reporter also indicated that it did not look like the tubing had slipped out of the y-site component. There was no patient involvement. No additional information is available.
 
Manufacturer Narrative
The device was not returned, however a photograph was received and evaluated. A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot. Visual inspection of the photograph and verified the reported condition. The cause of the condition is attributed to human error during the manufacturing process. Should additional relevant information become available, a supplemental report will be submitted.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

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
cartago 30106
CS 30106
Manufacturer Contact
25212 w. illinois route 120
round lake, IL 60073
2242702068
MDR Report Key6589336
MDR Text Key75919421
Report Number1416980-2017-04475
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K961225
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Reporter Occupation
Type of Report Initial,Followup
Report Date 06/28/2017
1 Device was Involved in the Event
0 Patients were Involved in the Event:
Date FDA Received05/24/2017
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number2C8519
Device Lot NumberR17C07067
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 Received06/02/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured03/08/2017
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

-
-