MAUDE Adverse Event Report: TERUMO BCT OPTIA WBC KIT; OPTIA SPECTRA APHERESIS SYSTEM

Model Number OPTIA WBC KIT

Device Problems Air Leak (1008); Break (1069); Device Displays Incorrect Message (2591)

Patient Problem Blood Loss (2597)

Event Date 06/06/2016

Event Type  Injury  

Event Description

Approx 4 hours into a stem cell collection, the optia device started to display an alarm.Some small air bubbles were noted in the cassette tray.Pt access and return lines were closed.Assessment of the tubing showed no visible kinks, clots or leaks.Next, the centrifuge was stopped and a visual inspection was also performed.No abnormalities noted.The procedure was restarted and the alarm continued.Again the tubing placement was correct and leak free.The instrument door was closed the procedure restarted.The procedure was restarted and at this time a loud noise and a blood leak alarm came on.All lines were immediately closed including the cellular therapy product.The centrifuge was opened and there was a visible blood leak in the centrifuge.The procedure was immediately halted.No rinseback performed and the pt was disconnected from the device.The md was notified as well as the stem cell lab.The cellular therapy product collected had a volume 300 ml and a plasma volume of 100 ml.The total whole blood volume processed was 12.121 liters.The extracorporeal blood loss was approx 191 ml.Blood cultures negative to date.When the device was unloaded, it was noted a break on the upper bearing which is inserted in the upper bearing holder.The procedural kit was not retained.Diagnosis or reason for use: multiple myeloma pt in for a stem cell collection.Is the product compounded: no.Is the product over-the-counter: no.

• Brand Name: OPTIA WBC KIT
• Type of Device: OPTIA SPECTRA APHERESIS SYSTEM
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 6547372
• MDR Text Key: 74629649
• Report Number: MW5069584
• Device Sequence Number: 1
• Product Code: LKN
• 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: 06/21/2016

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 05/04/2017
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Expiration Date: 04/01/2018
• Device Model Number: OPTIA WBC KIT
• Device Lot Number: 04Z3128
• 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
• Patient Age: 58 YR
• Patient Weight: 82