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U.S. Department of Health and Human Services

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

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BAXTER HEALTHCARE CORPORATION CLEARLINK CONTINU-FLO SOLUTION SET SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number 2H8519
Device Problem Backflow (1064)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Type  malfunction  
Event Description
It was reported that there was backflow of intravenous (iv) iron through an unspecified access primary set. It was stated that during the administration of iron iv via clearlink system secondary medication set through a colleague pump (rate of 125 ml/hr), the nurse noticed that the iron was moving up through the primary set. This issue was identified during patient infusion. There was no patient injury or medical intervention associated with this event. No additional information is available.
 
Manufacturer Narrative
This event occurred during an unknown date of (b)(6) 2021. 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 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 Key12771471
MDR Text Key280542648
Report Number1416980-2021-06635
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 Foreign,Health Professional,Company Representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/13/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/08/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number2H8519
Device Lot NumberASKU
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received12/13/2021
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: 11/08/2021 Patient Sequence Number: 1
Treatment
CLEARLINK SYSTEM SECONDARY MEDICATION SET; COLLEAGUE PUMP; IRON IV
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