• 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 SPECTRA OPTIA; SPECTRA OPTIA APHERESIS SYSTEM

  • 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 SPECTRA OPTIA; SPECTRA OPTIA APHERESIS SYSTEM Back to Search Results
Model Number 61000
Device Problems Use of Device Problem (1670); Inadequate User Interface (2958); Patient Data Problem (3197)
Patient Problem No Known Impact Or Consequence To Patient (2692)
Event Date 04/11/2016
Event Type  malfunction  
Manufacturer Narrative
Investigation is in process.A follow-up report will be provided.
 
Event Description
An internal investigation was performed of events in which an operator may have incorrectly entered patient data, creating an unreasonable body mass index (bmi).This event was identified during the internal investigation, not reported by the customer, therefore patient outcome is not available.Patient information is not available at this time.Entered weight of patient: (b)(6).Protocol performed: secondary plasma device (spd).
 
Manufacturer Narrative
The run data file (rdf) was reviewed for this run as part of an internal study.It was identified in the rdf that the patient weight and height may have been enteredincorrectly, resulting in an unreasonable body mass index.Such a data entry error can lead to, insome instances, an over infusion of ac or a hypervolemic or hypovolemic condition if the error isnot identified and corrected by the operator.There has been no indication that such an eventdid occur with this procedure.This issue was identified during an internal evaluation of available run data files.No on-siteservice was performed.One year of service history was reviewed for this device with no issues related to the reportedcondition identified.Terumo bct has followed up with this customer to provide feedback on the reported condition.Root cause: the root cause has been determined to be a user interface issue.Optia field action 24 has been initiated to correct this issue by releasing a safetynotification to all optia users to express the importance of entering the correct patient data andfollowing the operator's manual and on-screen prompts.An internal capa has been initiated to address incorrect patient dataentry.The field action referenced above will address this issue by updating all optia devices in thefield to software version 11.3.This software version will allow the optia device to determine ifentered patient height and weight combinations are feasible.
 
Event Description
Due to (b)(6) personal data protection laws, the patient information is not available from the customer.Patient¿s gender and weight were obtained from the run data file (rdf).
 
Search Alerts/Recalls

  New Search  |  Submit an Adverse Event Report

Brand Name
SPECTRA OPTIA
Type of Device
SPECTRA OPTIA APHERESIS SYSTEM
Manufacturer (Section D)
TERUMO BCT
lakewood CO 80215
Manufacturer Contact
steve kern
10810 w. collins ave
lakewood, CO 80215
3032392246
MDR Report Key6395065
MDR Text Key70056185
Report Number1722028-2017-00064
Device Sequence Number1
Product Code LKN
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K131744
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type company representative
Reporter Occupation Health Professional
Remedial Action Notification
Type of Report Initial,Followup
Report Date 03/10/2017
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 Model Number61000
Other Device ID Number05020583610002
Was Device Available for Evaluation? Yes
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 02/13/2017
Initial Date FDA Received03/10/2017
Supplement Dates Manufacturer ReceivedNot provided
Supplement Dates FDA Received03/23/2017
Was Device Evaluated by Manufacturer? Device Not Returned to Manufacturer
Date Device Manufactured09/04/2013
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Unknown
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Weight85
-
-