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U.S. Department of Health and Human Services

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

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BAXTER HEALTHCARE CORPORATION CLEARLINK CONTINU-FLO SOLUTION SET SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number 2H8519
Device Problems Partial Blockage (1065); No Flow (2991)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/25/2019
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 unspecified solution would not flow through the line of a clearlink system non-dehp continu-flo solution set. It was further reported that the chamber was occluded. This was identified during patient infusion. There was no patient injury or medical intervention associated with this event. No additional information is available.
 
Manufacturer Narrative
Additional information : the device was received for evaluation. Visual inspection did not identify any abnormalities that could have contributed to the reported condition. Functional test including pressure and clear passage under water testing were performed and the tubing was observed blocked inside the drip chamber. The reported condition was verified. The cause of the condition was due to excess solvent on the drip chamber. The medical dispenser was replaced. There are manufacturing process controls in place to detect and prevent blockages from occurring. A nonconformance has been opened to address this issue. 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.
 
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Brand NameCLEARLINK CONTINU-FLO SOLUTION SET
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
deerfield IL
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 Key9531552
MDR Text Key173094330
Report Number1416980-2019-07235
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeCO
PMA/PMN Number
K961225
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation Pharmacist
Type of Report Initial,Followup
Report Date 02/05/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/30/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number2H8519
Device Lot NumberR19H08070
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer01/10/2020
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received01/28/2020
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured08/09/2019
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 12/30/2019 Patient Sequence Number: 1
Treatment
SOLUTION (UNSPECIFIED)
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