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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: FENWAL, INC. AMICUS MNC APHERESIS KIT WITH DOUBLE NEEDLE; SEPARATOR, AUTOMATED, BLOOD CELL, DIAGNOSTIC
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FENWAL, INC. AMICUS MNC APHERESIS KIT WITH DOUBLE NEEDLE; SEPARATOR, AUTOMATED, BLOOD CELL, DIAGNOSTIC Back to Search Results
Model Number X6R2326
Device Problem Fluid/Blood Leak (1250)
Patient Problem Insufficient Information (4580)
Event Date 11/30/2022
Event Type  malfunction  
Event Description
Rn doing auto stem cell collection when the machine stopped at mid cycle 14 and alarmed noting centrifuge leak and blood all over the centrifuge.Leak noted at one of the chambers of the centrifuge pack of the kit used with lot #fa22g25121.Procedure aborted.Pic manager, bmt lab and company made aware.Manufacturer response for apheresis blood collection set, amicus mnc apheresis kit with double needle (per site reporter).Not known.
 
Event Description
Rn doing auto stem cell collection when the machine stopped at mid cycle 14 and alarmed noting centrifuge leak and blood all over the centrifuge.Leak noted at one of the chambers of the centrifuge pack of the kit used with lot #fa22g25121.Procedure aborted.Pic manager, bmt lab and company made aware.Manufacturer response for apheresis blood collection set, amicus mnc apheresis kit with double needle (per site reporter).Not known.
 
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Brand Name
AMICUS MNC APHERESIS KIT WITH DOUBLE NEEDLE
Type of Device
SEPARATOR, AUTOMATED, BLOOD CELL, DIAGNOSTIC
Manufacturer (Section D)
FENWAL, INC.
three corporate drive
2nd floor
lake zurich IL 60047
MDR Report Key15958500
MDR Text Key305252367
Report Number15958500
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,Followup
Report Date 12/06/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/12/2022
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 NumberFA22G25121
Was Device Available for Evaluation? Device Returned to Manufacturer
Date Returned to Manufacturer12/02/2022
Is the Reporter a Health Professional? Yes
Was the Report Sent to FDA? Yes
Date Report Sent to FDA12/06/2022
Event Location Hospital
Date Report to Manufacturer12/12/2022
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Age26280 DA
Patient SexMale
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