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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 2C7461
Device Problems Complete Blockage (1094); Disconnection (1171); Fluid/Blood Leak (1250)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
It was reported that there was a connection issue between a clearlink system continu-flo solution set and a clearlink system secondary medication set which resulted in a blockage and leak of solution. The connection issue was described as, the connector at the end of the secondary set does not work with the integrated needleless connectors that are installed on the primary set. When attaching the secondary tubing to the needleless connector on the primary tubing, there appeared to be a blockage. When the tubing was removed from the needleless connector, the fluid leaked out of the disconnected tubing because of the back pressure. This was observed during an unspecified process step. There was no report of patient injury or medical intervention associated with this event. No additional information is available.
 
Manufacturer Narrative
Initial reporter address: (b)(6). 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
singapore
SN
Manufacturer Contact
25212 w. illinois route 120
round lake, IL 
2242702068
MDR Report Key15233296
MDR Text Key302335148
Report Number1416980-2022-04261
Device Sequence Number1
Product Code FPA
UDI-Device Identifier00085412049069
UDI-Public(01)00085412049069
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K203609
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 09/15/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/16/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number2C7461
Device Lot NumberSR22F14041
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received09/11/2022
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: 08/16/2022 Patient Sequence Number: 1
Treatment
CLEARLINK CONTINU-FLO SOLUTION SET; NORMAL SALINE
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