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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 Problem Use of Device Problem (1670)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 11/14/2019
Event Type  malfunction  
Manufacturer Narrative
The suspected lot numbers were reported (b)(4).(b)(6).(b)(4).Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported a clearlink system continu-flo solution set was difficult to use in conjunction with a clearlink system secondary medication set.It was further reported the primary tubing was ¿not allowing the secondary set to pull from the bag¿.This issue was identified during patient use.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
 
Manufacturer Narrative
Additional information was added to d10, h3, h4 and h6.H4: the potential lot number¿s were manufactured on: r19h14037- 08/16/2019, r19g22057- 07/23/2019, r19h07130- 08/08/2019, r19h23053- 08/24/2019.H10: the device was received for evaluation.All components are correctly placed and according to specifications.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.Functional testing was performed, including pressure and clear passage testing; and the device operated according to product specifications.The reported condition was not verified.A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot.Should additional relevant information become available, a supplemental report will be submitted.
 
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Brand Name
CLEARLINK DUO-VENT CONTINU-FLO SOLUTION SET
Type of Device
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
deerfield IL
MDR Report Key9452831
MDR Text Key170433552
Report Number1416980-2019-06828
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
PMA/PMN Number
K961225
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 01/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/11/2019
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue Number2C8541
Device Lot NumberASKU
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/13/2019
Date Manufacturer Received12/19/2019
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
CLEARLINK SYSTEM SECONDARY MEDICATION SET
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