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

Model Number SPECTRA OPTIA

Device Problems Loss of Power (1475); Self-Activation or Keying (1557)

Patient Problem No Code Available (3191)

Event Date 04/28/2020

Event Type  malfunction  

Event Description

Staff report: 14 minutes after starting stem cell collection, the apheresis machine issued a warning then immediately switched to a blue dos screen and then shut itself down.I came into the room at this point and tried to troubleshoot.We turned the machine back on and got a "processor for safety system failed to start correctly" warning.It suggested either restarting the machine or calling the company for assistance.I called the company since the machine had just restarted and she directed me to restart the machine.It brought us to a screen where we had to disconnect so that is what we did.Meanwhile i pulled the machine out of service.We were able to start over on a new machine but the patient need to be exposed to a second unit of blood for the blood prime as a result of this malfunction.Manufacturer came on site to evaluate the system.Service report states: examined dlogs and found 2 instances of safety failed to boot.Replaced safety stack, rj-45 cable and performed mother board alignment as per mfg procedures.

• Brand Name: SPECTRA OPTIA
• Type of Device: SEPARATOR, AUTOMATED, BLOOD CELL, DIAGNOSTIC
• Manufacturer (Section D): TERUMO BCT, INC.; 10811 w. collins avenue; lakewood CO 80215
• MDR Report Key: 10147932
• MDR Text Key: 194946584
• Report Number: 10147932
• Device Sequence Number: 1
• Product Code: GKT
• Combination Product (y/n): N
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: User Facility
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 05/27/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 06/12/2020
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Model Number: SPECTRA OPTIA
• Was Device Available for Evaluation?: Yes
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Report Sent to FDA: 05/27/2020
• Device Age: 5 YR
• Event Location: Hospital
• Date Report to Manufacturer: 06/12/2020
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: N
• Patient Sequence Number: 1
• Patient Age: 1 DA