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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 No Clinical Signs, Symptoms or Conditions (4582)
Event Date 11/14/2022
Event Type  malfunction  
Event Description
The allogenic stem cell collection was nearing the end of the day.The patient was in cycle number 11 of the 12 planned cycles.The apheresis rn received a centrifuge leak alarm and noted blood leak in the centrifuge compartment.The product and plasma bags were immediately clamped.The procedure was aborted due to this leak.Unfortunately the patient could not have re-infusion of blood back at the end of the procedure as the sterile kit had been breached.A post cbc was drawn.The patient was stable and the happenings were explained to her.Manufacturer response for stem cell collection kit, amicus mnc apheresis kit with double needle (per site reporter) unknown.
 
Event Description
The allogenic stem cell collection was nearing the end of the day.The patient was in cycle number 11 of the 12 planned cycles.The apheresis rn received a centrifuge leak alarm and noted blood leak in the centrifuge compartment.The product and plasma bags were immediately clamped.The procedure was aborted due to this leak.Unfortunately the patient could not have re-infusion of blood back at the end of the procedure as the sterile kit had been breached.A post cbc was drawn.The patient was stable and the happenings were explained to her.Manufacturer response for stem cell collection kit, amicus mnc apheresis kit with double needle (per site reporter).
 
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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 IL 60047
MDR Report Key15958476
MDR Text Key305250301
Report Number15958476
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 Manufacturer11/15/2022
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 Outcome(s) Other;
Patient Age22265 DA
Patient SexFemale
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