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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION CLEARLINK DUO-VENT SOLUTION ADMINISTRATION SETS; SET, ADMINISTRATION, INTRAVASCULAR
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BAXTER HEALTHCARE CORPORATION CLEARLINK DUO-VENT SOLUTION ADMINISTRATION SETS; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number 2H8480
Device Problem Filling Problem (1233)
Patient Problem No Consequences Or Impact To Patient (2199)
Event Date 01/08/2020
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 non dehp solution set under infused.The expected infusion time was one hour; however, the actual infusion time was an hour and fifty minutes.The device was filled with 500ml of etoposide programmed at 500ml/hour via a baxter spectrum pump.There was no 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 SOLUTION ADMINISTRATION SETS
Type of Device
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
deerfield IL
MDR Report Key9665809
MDR Text Key177627855
Report Number1416980-2020-00389
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
PMA/PMN Number
K153158
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Type of Report Initial,Followup
Report Date 03/10/2020
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received02/04/2020
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number2H8480
Was Device Available for Evaluation? No
Date Manufacturer Received02/25/2020
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Treatment
BAXTER SPECTRUM PUMP; ETOPOSIDE; BAXTER SPECTRUM PUMP; ETOPOSIDE
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