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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION CLEARLINK SECONDARY MEDICATION SET SET, ADMINISTRATION, INTRAVASCULAR

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BAXTER HEALTHCARE CORPORATION CLEARLINK SECONDARY MEDICATION SET SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number JC7453
Device Problems Backflow (1064); Air/Gas in Device (4062)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/26/2021
Event Type  malfunction  
Event Description
It was reported that a clearlink system secondary medication set had air in the line and back flow. The set-up is a secondary unspecified chemotherapy iv bag is spiked with a non-baxter device; connected on the other end is a non-dehp extension set. At the opposite end of the non-dehp extension set is a non-baxter closed male luer which is connected to a clearlink system secondary medication set. They then connect to the upper y port of the clearlink system continu-flo solution set. ¿the issue is that when the secondary infusion ran complete the secondary iv set had air in the line but still had fluid in the secondary drip chamber and there was no fluid in the secondary medication bag¿. It is further observed ¿there is back flow from the primary up into the secondary set when this set up is used¿. The event occurred post chemo infusion. There was no patient injury or medical intervention associated with this event. No additional information is available.
 
Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
 
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Brand NameCLEARLINK SECONDARY MEDICATION SET
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
deerfield IL
Manufacturer (Section G)
BAXTER HEALTHCARE - SINGAPORE
2 woodlands industrial park d
street 2
singapore 73875 0
SN 738750
Manufacturer Contact
25212 w. illinois route 120
round lake, IL 
2242702068
MDR Report Key13060590
MDR Text Key282725416
Report Number1416980-2021-07504
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeCA
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 01/20/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/22/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberJC7453
Device Lot NumberASKU
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received01/03/2022
Was Device Evaluated by Manufacturer? No Answer Provided
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial

Patient Treatment Data
Date Received: 12/22/2021 Patient Sequence Number: 1
Treatment
BD PHASEAL DEVICE; CLEARLINK SYSTEM CONTINU-FLO SOLUTION SET; NON-DEHP EXTENSION SET; UNSPECIFIED CHEMOTHERAPY SOLUTION
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