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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: BAXTER INTERNATIONAL INC. CLEARLINK SET, ADMINISTRATION, INTRAVASCULAR

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BAXTER INTERNATIONAL INC. CLEARLINK SET, ADMINISTRATION, INTRAVASCULAR Back to Search Results
Model Number 2H8603
Device Problems Fluid Leak (1250); Material Puncture/Hole (1504); Product Quality Problem (1506); Inaccurate Delivery (2339); Filtration Problem (2941)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 10/07/2021
Event Type  malfunction  
Event Description
Rn noted patients (b)(6) and bed linens to be damp in morning, noted tpn fluid to be seeping out of one of the indents (holes) in the back of the tpn filter cartridge. Emailed baxter with the incident details and requested an rma and mailer to return the sample for analysis. Baxter email question received and answered.
 
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Brand NameCLEARLINK
Type of DeviceSET, ADMINISTRATION, INTRAVASCULAR
Manufacturer (Section D)
BAXTER INTERNATIONAL INC.
one baxter parkway
deerfield IL 60015
MDR Report Key13009769
MDR Text Key282275535
Report Number13009769
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation
Type of Report Initial
Report Date 11/30/2021
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/15/2021
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator
Device Model Number2H8603
Device Catalogue Number2H8603
Device Lot NumberR21D10030
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer11/18/2021
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA11/30/2021
Event Location Hospital
Date Report to Manufacturer12/15/2021
Was Device Evaluated by Manufacturer? No Answer Provided
Type of Device Usage Unkown

Patient Treatment Data
Date Received: 12/15/2021 Patient Sequence Number: 1
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