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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION CLEARLINK LUER ACTIVATED VALVE SET, ADMINISTRATION, INTRAVASCULAR

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BAXTER HEALTHCARE CORPORATION CLEARLINK LUER ACTIVATED VALVE SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number JC8419
Device Problems Filling Problem (1233); Protective Measures Problem (3015)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 07/28/2022
Event Type  malfunction  
Event Description
It was reported that there was an overinfusion during use with a clearlink system solution set. The set was being used for intravenous immunoglobulin (ivig) therapy with a spectrum iq pump. The first 300ml bottle had four (4) upstream occlusion alarms at different times throughout the infusion and that bottle ended up with a delivered volume of 370ml. Then the second 300 ml bottle had no upstream alarms but delivered a total volume of 383 ml. This was observed during patient infusion. There was no report of 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 LUER ACTIVATED VALVE
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 73875 0
SN 738750
Manufacturer Contact
25212 w. illinois route 120
round lake, IL 
2242702068
MDR Report Key15266322
MDR Text Key301760690
Report Number1416980-2022-04366
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 Other Health Care Professional
Type of Report Initial,Followup
Report Date 09/26/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received08/22/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberJC8419
Device Lot NumberASKU
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received09/16/2022
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: 08/22/2022 Patient Sequence Number: 1
Treatment
INTRAVENOUS IMMUNOGLOBULIN (IVIG).; SPECTRUM IQ PUMP.
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