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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER HEALTHCARE CORPORATION CLEARLINK SOLUTION ADMINISTRATION SETS; SET, ADMINISTRATION, INTRAVASCULAR
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BAXTER HEALTHCARE CORPORATION CLEARLINK SOLUTION ADMINISTRATION SETS; SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Catalog Number 2H8671
Device Problem Fluid/Blood Leak (1250)
Patient Problem Hypoglycemia (1912)
Event Date 04/28/2021
Event Type  Injury  
Manufacturer Narrative
Mfr site : device manufacturer address 1: (b)(4).Should additional relevant information become available, a supplemental report will be submitted.
 
Event Description
It was reported that after six hours of patient infusion of dextrose 12.5% at 6 ml/hr using a clearlink set, leakage was observed, and the patient's bed mattress became wet.Subsequently, the patient experienced ¿blood sugar dropped¿ (values not provided).A new bag with the medication was set up.The leak was observed ¿where the flat piece connects to the cylinder of the filter¿.No separation or cracks were observed.It was reported the luer connections were checked prior to use.The cause of the leak was not reported.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
The device was received for evaluation.Visual inspection did not identify any abnormalities that could have contributed to the reported condition.Pressure test and clear passage under water testing was performed with no issues noted.Priming was performed at the set with a bag of sterile water and leak was observed in the vent of filter.The reported condition of leak was verified.The cause of the condition was determined to be a manufacturing issue.This issue is being further investigated.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 SOLUTION ADMINISTRATION SETS
Type of Device
SET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
BAXTER HEALTHCARE CORPORATION
deerfield IL
MDR Report Key11863519
MDR Text Key251949535
Report Number1416980-2021-03090
Device Sequence Number1
Product Code FPA
UDI-Device Identifier00085412080956
UDI-Public(01)00085412080956
Combination Product (y/n)Y
PMA/PMN Number
K153158
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative,health
Type of Report Initial,Followup
Report Date 06/29/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received05/21/2021
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number2H8671
Device Lot NumberR21A30117
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer05/27/2021
Date Manufacturer Received06/23/2021
Is This a Reprocessed and Reused Single-Use Device? No
Patient Sequence Number1
Patient Outcome(s) Required Intervention;
Patient Age1 DA
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