MAUDE Adverse Event Report: TERUMO BCT, INC. APHERESIS KIT; SEPARATOR, AUTOMATED, BLOOD CELL, DIAGNOSTIC

Lot Number 2010093130

Device Problems Device Alarm System (1012); Complete Blockage (1094)

Patient Problem Insufficient Information (4580)

Event Date 03/26/2021

Event Type  malfunction  

Event Description

Patient underwent autologous stem cell collection (b)(6) 2021.At the end of collection, product was noted to be clotted and unsuitable for use.As a result, the product was discarded.Terumobct was notified.It was found the second bag of acd-a hung was not properly infusing into the product, though no alarms were produced to notify the operator of the interrupted ac flow.Apheresis kit # 2010093130, exp 10/1/22; acd-a, lot # 20044084, exp 10/1/22.The patient had to return a subsequent to re-collect.Fda safety report id# (b)(4).

• Brand Name: APHERESIS KIT
• Type of Device: SEPARATOR, AUTOMATED, BLOOD CELL, DIAGNOSTIC
• Manufacturer (Section D): TERUMO BCT, INC.
• MDR Report Key: 11607943
• MDR Text Key: 243771026
• Report Number: MW5100510
• Device Sequence Number: 1
• Product Code: GKT
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Nurse
• Type of Report: Initial
• Report Date: 03/30/2021

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 Expiration Date: 10/01/2022
• Device Lot Number: 2010093130
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: Not provided
• Initial Date FDA Received: 04/01/2021
• Was Device Evaluated by Manufacturer?: No Information
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Outcome(s): Other
• Patient Age: 63 YR
• Patient Weight: 77