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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 Filling Problem (1233)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Type  malfunction  
Manufacturer Narrative
(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 under infused.The unspecified primary medication was infused via a baxter spectrum iq infusion pump at 400ml/hour.When the infusion was completed, approximately 25ml of the solution had not infused and remained in the bag.There was no report of patient injury or medical intervention associated with this event.No additional information is available.
 
Manufacturer Narrative
The device was not returned, and the lot number is unknown; therefore, a device analysis could not be completed.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 Key10269026
MDR Text Key198688490
Report Number1416980-2020-03965
Device Sequence Number1
Product Code FPA
Combination Product (y/n)Y
PMA/PMN Number
K961225
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 08/13/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/14/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number2C8541
Was Device Available for Evaluation? No
Date Manufacturer Received08/03/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
SPECTRUM IQ INFUSION PUMP; UNSPECIFIED DRUG SOLUTION; SPECTRUM IQ INFUSION PUMP; UNSPECIFIED DRUG SOLUTION
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