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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FRESENIUS KABI AG AMICUS MNC APHERESIS KIT - DOUBLE NEEDLE; SEPARATOR, AUTOMATED, BLOOD CELL, DIAGNOSTIC
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FRESENIUS KABI AG AMICUS MNC APHERESIS KIT - DOUBLE NEEDLE; SEPARATOR, AUTOMATED, BLOOD CELL, DIAGNOSTIC Back to Search Results
Model Number X6R2326
Device Problem Fluid/Blood Leak (1250)
Patient Problem Hemorrhage/Bleeding (1888)
Event Date 12/20/2022
Event Type  malfunction  
Event Description
Centrifuge blood leak in cycle 12 of apheresis procedure, procedure ended 20 minutes early and unable to perform reinfusion.Total blood processed: 17416 ml.Procedure ran for 336 minutes instead of 360 minutes.Patient experienced approximately 163 ml of blood loss.Vss stable and no complaints at end of procedure.Manufacturer response for amicus mnc apheresis kit - double needle, amicus mnc apheresis kit - double needle (per site reporter).Fresenius stated that they have found the manufacturing defect and is producing new collection sets.
 
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Brand Name
AMICUS MNC APHERESIS KIT - DOUBLE NEEDLE
Type of Device
SEPARATOR, AUTOMATED, BLOOD CELL, DIAGNOSTIC
Manufacturer (Section D)
FRESENIUS KABI AG
three corporate drive 2nd floor
lake zurich IL 60047
MDR Report Key16321709
MDR Text Key309043524
Report Number16321709
Device Sequence Number1
Product Code GKT
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Other Health Care Professional
Type of Report Initial
Report Date 02/03/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Model NumberX6R2326
Device Catalogue NumberX6R2326
Device Lot NumberFA22H22134
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA02/03/2023
Event Location Outpatient Treatment Facility
Date Report to Manufacturer02/08/2023
Initial Date Manufacturer Received Not provided
Initial Date FDA Received02/08/2023
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Age14600 DA
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