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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 2H8401
Device Problems Fluid Leak (1250); Material Split, Cut or Torn (4008)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/09/2021
Event Type  malfunction  
Manufacturer Narrative
Device manufacturer address: (b)(4). Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported a clearlink system non-dehp solution set line was "splitting horizontally" which resulted in a leak of an unknown chemotherapy drug. It was further reported that once the line started to split, the blue slide would push the tubing and cause the alarm to go off and when the pump was opened, saline or chemotherapy drug would spill out. This issue was found while attached to the patient. The device was used with flogard pump. The chemotherapy drug was reported as "infliximab, nivolumab or pembrolizumab. There was no patient injury or medical intervention associated with this event. No additional information is available.
 
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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 - CARTAGO
see h10
see h10
cartago 30106
CS 30106
Manufacturer Contact
25212 w. illinois route 120
round lake, IL 
2242702068
MDR Report Key12158998
MDR Text Key261257796
Report Number1416980-2021-04261
Device Sequence Number1
Product Code FPA
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
K112893
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation
Type of Report Initial,Followup
Report Date 08/12/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/13/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number2H8401
Device Lot NumberR20E08057
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received08/10/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Date Device Manufactured05/09/2020
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: 07/13/2021 Patient Sequence Number: 1
Treatment
(INFLIXIMAB, NIVOLUMAB OR PEMBROLIZUMAB); CHEMOTHERAPY (UNKNOWN); FLOGARD PUMP; NORMAL SALINE
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