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U.S. Department of Health and Human Services

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

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BAXTER HEALTHCARE CORPORATION CLEARLINK DUO-VENT CONTINU-FLO SOLUTION SET SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number 2C8541
Device Problems Filling Problem (1233); Material Twisted/Bent (2981); No Flow (2991)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 08/10/2021
Event Type  malfunction  
Manufacturer Narrative
(b)(4). Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that a clearlink system continu-flo solution set under infused. This occurred during infusion with calcium chloride. It was stated that the new bag hung only had about 100 ml gone where almost 500 ml should have infused. When the tubing was taken out of the pump it was noted it was completely flat and occluded. It was further reported that the unspecified pump never alarmed and stated the volume had infused. There was no report of patient injury or medical intervention associated with this event. No additional information is available.
 
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Brand NameCLEARLINK DUO-VENT 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 Key12454151
MDR Text Key270840686
Report Number1416980-2021-05590
Device Sequence Number1
Product Code FPA
Combination Product (y/n)Y
Reporter Country CodeUS
PMA/PMN Number
K961225
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 10/15/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received09/10/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue Number2C8541
Device Lot NumberASKU
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer09/07/2021
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received10/12/2021
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
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: 09/10/2021 Patient Sequence Number: 1
Treatment
CALCIUM CHLORIDE; UNSPECIFIED PUMP
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