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

Model Number 90819

Device Problems Disconnection (1171); Loose or Intermittent Connection (1371)

Patient Problem Insufficient Information (4580)

Event Date 12/15/2020

Event Type  Injury  

Event Description

Upon debulking a marrow on the cobe cell washer, a line became loose and disconnected from the cobe bag.We opened up another bag of the same lot and tried to re-create the event, but couldn't get the line to loosen or pull away from the bag.We think it was a faulty bag initially.Fda safety report id # (b)(4).

• Brand Name: SEPARATOR, AUTOMATED, BLOOD CELL, DIAGNOSTIC
• Type of Device: SEPARATOR, AUTOMATED, BLOOD CELL, DIAGNOSTIC
• Manufacturer (Section D): TERUMO BCT INC. ; lakewood CO 80215
• MDR Report Key: 11261212
• MDR Text Key: 230090839
• Report Number: MW5099119
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): Y
• Reporter Country Code: US
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Voluntary
• Reporter Occupation: Administrator/Supervisor
• Type of Report: Initial
• Report Date: 01/28/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 01/29/2021
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 09/01/2022
• Device Model Number: 90819
• Device Catalogue Number: 90819
• Device Lot Number: 09D15004
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• 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): Required Intervention