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U.S. Department of Health and Human Services

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

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BAXTER HEALTHCARE-AIBONITO CLEARLINK CONTINU-FLO SOLUTION SET SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number 2H8537
Device Problems Fluid Leak (1250); Cut In Material (2454)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 09/15/2016
Event Type  malfunction  
Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that a clearlink system non-dehp continu-flo solution set leaked from a laceration directly under the slide clamp during infusion of chemotherapy. The set was used with a baxter pump. There was no report of patient injury or medical intervention associated with this event. No additional information is available.
 
Manufacturer Narrative
The device was received for evaluation out of the pouch and fully primed with chemo. Visual inspection noted a cut and a leak in the tubing located approximately 2 inches below the top y-site. The reported condition was verified. The cause of the condition could not be determined. 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-AIBONITO
aibonito
Manufacturer (Section G)
BAXTER HEALTHCARE-AIBONITO
rd 721 km 0 3 po box 1389
aibonito 00705
Manufacturer Contact
25212 w. illinois route 120
round lake, IL 60073
2242702068
MDR Report Key6045650
MDR Text Key58019156
Report Number1416980-2016-16480
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
K961225
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 11/23/2016
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received10/20/2016
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Expiration Date04/19/2021
Device Catalogue Number2H8537
Device Lot NumberR16D19145
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer10/25/2016
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received11/11/2016
Was Device Evaluated by Manufacturer? Yes
Date Device Manufactured04/20/2016
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage

Patient Treatment Data
Date Received: 10/20/2016 Patient Sequence Number: 1
Treatment
CHEMOTHERAPY; COLLEAGUE TRIPLE PUMP
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