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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FRESENIUS KABI USA, LLC LVP PRIMARY ADMIN SET 2 INLET & YSITE; ADMINISTRATION SET
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FRESENIUS KABI USA, LLC LVP PRIMARY ADMIN SET 2 INLET & YSITE; ADMINISTRATION SET Back to Search Results
Catalog Number SET0032
Device Problems Failure to Infuse (2340); Infusion or Flow Problem (2964)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/24/2023
Event Type  malfunction  
Event Description
The following has been reported: the problems have been unable to load the cassette or the secondary port.The issues have delayed treatment several minutes while troubleshooting and trying to find tubing that would work.This morning i had to turn the pump off then on, try a second pump then get a second tubing on the first patient then the second patient it took 3 lines before i got one that worked.Delayed starting therapy but did not delay an active infusion.Reporting due to the referenced issue.No adverse effects were reported.More information is needed to complete the investigation.
 
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Brand Name
LVP PRIMARY ADMIN SET 2 INLET & YSITE
Type of Device
ADMINISTRATION SET
Manufacturer (Section D)
FRESENIUS KABI USA, LLC
50 high street
suite 50
north andover MA 01845
Manufacturer (Section G)
FRESENIUS KABI USA, LLC
50 high street
suite 50
north andover MA 01845
Manufacturer Contact
rebecca mccandless
3 corporate drive
lake zurich, IL 60047-8930
8475502913
MDR Report Key18389793
MDR Text Key331495068
Report Number3014732157-2023-00241
Device Sequence Number1
Product Code FPA
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K183311
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type User Facility
Reporter Occupation Other
Type of Report Initial
Report Date 12/23/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/23/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Other
Device Catalogue NumberSET0032
Was Device Available for Evaluation? Yes
Date Manufacturer Received11/24/2023
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 Initial
Patient Sequence Number1
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