• Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

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

  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 

TERUMO BCT, INC. SPECTRA OPTIA®; SEPARATOR, AUTOMATED, BLOOD CELL, DIAGNOSTIC Back to Search Results
Lot Number 2211216241
Patient Problem Insufficient Information (4580)
Event Date 02/14/2023
Event Type  malfunction  
Event Description
Patient was undergoing apheresis stem cell collection.Healthcare providers identified return pressure alarms with poor flow.Unable to obtain blood flow greater than 50-60ml/min.Flushing, reversing and repositioning of patient was attempted without change to.Upon inspection of tubing during attempts at fixing return flow, identified hermetic seal on return line.New kit set-up/primed.No other experienced once kit changed.
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
SPECTRA OPTIA®
Type of Device
SEPARATOR, AUTOMATED, BLOOD CELL, DIAGNOSTIC
Manufacturer (Section D)
TERUMO BCT, INC.
10810 west collins avenue
lakewood CO 80215
MDR Report Key18147602
MDR Text Key328260671
Report Number18147602
Device Sequence Number1
Product Code GKT
Combination Product (y/n)N
Number of Events Reported1
Summary Report (Y/N)N
Report Source User Facility
Reporter Occupation Risk Manager
Type of Report Initial
Report Date 09/23/2023,09/22/2023
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 Lot Number2211216241
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? No
Was the Report Sent to FDA? Yes
Date Report Sent to FDA09/23/2023
Event Location Hospital
Date Report to Manufacturer11/16/2023
Initial Date Manufacturer Received Not provided
Initial Date FDA Received11/16/2023
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Age23360 DA
Patient SexMale
Patient Weight93 KG
-
-