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U.S. Department of Health and Human Services

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

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BAXTER HEALTHCARE CORPORATION DUO-VENT CLEARLINK LUER ACTIVATED VALVE SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number 2R8875
Device Problems No Flow (2991); Protective Measures Problem (3015)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Manufacturer Narrative
This event occurred during an unspecified date of june 2020. Device manufacturer address 1: (b)(4). Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that an unspecified iv (intravenous) infusion pump displayed an a ¿downstream occlusion alarm¿ while being used with a clearlink system, solution set. It was further reported that inorder to clear the alarm, the nurse secured a saline flush syringe to the addition port (clearlink port). Once the port¿s mechanism was depressed, the infusion pump began to infuse. The set-up was infusing valproate sodium. There was no report of patient injury or medical intervention associated with this event. No additional information is available.
 
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Brand NameDUO-VENT CLEARLINK LUER ACTIVATED VALVE
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 
2242702068
MDR Report Key15078965
MDR Text Key297227871
Report Number1416980-2022-03772
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K180739
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional,Company Representative
Reporter Occupation Pharmacist
Type of Report Initial,Followup,Followup
Report Date 08/25/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/21/2022
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number2R8875
Device Lot NumberASKU
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/19/2022
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: 07/21/2022 Patient Sequence Number: 1
Treatment
IV INFUSION PUMP; SALINE FLUSH SYRINGE; VALPROATE SODIUM
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