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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TERUMO BCT, INC. APHERESIS KIT; SEPARATOR, AUTOMATED, BLOOD CELL, DIAGNOSTIC
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TERUMO BCT, INC. APHERESIS KIT; SEPARATOR, AUTOMATED, BLOOD CELL, DIAGNOSTIC Back to Search Results
Lot Number 2102113130
Device Problems Coagulation in Device or Device Ingredient (1096); No Flow (2991)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 04/14/2021
Event Type  malfunction  
Event Description
Patient for second day of autologous stem cell collection (b)(6) 2021.During procedure, clot noted in collection bag.Upon observation, no acd-a was draining from the bag.Md informed and ordered additional acd-a to be added to the product.Stem cell processing facility notified of clotting issue prior to sending product to the lab.Of note, the rn visualized the acd-a was dripping when it was hung, and no alarms were made by the machine.Kit lot # 2102113130, exp 2/1/2023; acd-a lot # 4359801, exp 8/22/2021.Fda safety report id# (b)(4).
 
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Brand Name
APHERESIS KIT
Type of Device
SEPARATOR, AUTOMATED, BLOOD CELL, DIAGNOSTIC
Manufacturer (Section D)
TERUMO BCT, INC.
lakewood CO 80215
MDR Report Key11684932
MDR Text Key246260738
Report NumberMW5100829
Device Sequence Number1
Product Code GKT
Reporter Country CodeUS
Number of Events Reported1
Summary Report (Y/N)N
Report Source Voluntary
Reporter Occupation Nurse
Type of Report Initial
Report Date 04/14/2021
2 Devices were Involved in the Event: 1   2  
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 Expiration Date02/01/2023
Device Lot Number2102113130
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received Not provided
Initial Date FDA Received04/16/2021
Was Device Evaluated by Manufacturer? No Information
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage N
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age51 YR
Patient Weight100
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