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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE - DOMINICAN REPUBLIC CLEARLINK BURETROL SOLUTION SETS SET, ADMINISTRATION, INTRAVASCULAR

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BAXTER HEALTHCARE - DOMINICAN REPUBLIC CLEARLINK BURETROL SOLUTION SETS SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number A2C9801
Device Problem Filling Problem (1233)
Patient Problem Respiratory Distress (2045)
Event Date 10/16/2018
Event Type  Injury  
Manufacturer Narrative
Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
A pediatric patient experienced respiratory distress after the burette of a clearlink buretrol set overfilled. It was reported the burette overfilled ¿1 hour later¿ after initiation of treatment with normal saline and "flucloacillin". The cause of the burette overfill was reported as due to a failed roller clamp (between the iv bag and the burette chamber). A full line change was required. It was reported the patient was fluid restricted. The amount of the fluid overfill was not reported. Seven hours after the overfill, the patient experienced respiratory distress and was transferred to the intensive care unit. Treatment for the event was not reported. At the time of this report, the patient outcome was not reported. No additional information is available.
 
Manufacturer Narrative
A batch review was conducted and there were no deviations found related to this reported condition during the manufacture of this lot. The device was not received for evaluation; 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 NameCLEARLINK BURETROL SOLUTION SETS
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
BAXTER HEALTHCARE - DOMINICAN REPUBLIC
haina, san cristobal
Manufacturer (Section G)
BAXTER HEALTHCARE - DOMINICAN REPUBLIC
carretera sanchez km 18.5
parque industrial itabo, piisa
haina, san cristobal
DR
Manufacturer Contact
25212 w. illinois route 120
round lake, IL 60073
2242702068
MDR Report Key8057042
MDR Text Key126723780
Report Number1416980-2018-07140
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeAS
PMA/PMN Number
NA
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,foreig
Reporter Occupation
Type of Report Initial,Followup
Report Date 12/14/2018
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received11/09/2018
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator
Device Catalogue NumberA2C9801
Device Lot NumberDR18C12025
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA?
Event Location No Information
Date Manufacturer Received12/04/2018
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

Patient Treatment Data
Date Received: 11/09/2018 Patient Sequence Number: 1
Treatment
"FLUCLOACILLIN"; NORMAL SALINE
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