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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TERUMO BCT SPECTRA OPTIA; SPECTRA OPTIA SYSTEM
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TERUMO BCT SPECTRA OPTIA; SPECTRA OPTIA SYSTEM Back to Search Results
Catalog Number 10116
Device Problems Use of Device Problem (1670); Insufficient Information (3190); Device Handling Problem (3265)
Patient Problem No Clinical Signs, Symptoms or Conditions (4582)
Event Date 01/10/2023
Event Type  malfunction  
Manufacturer Narrative
Investigation: the run data file (rdf) was analyzed for this event.Review of the rdf and aim images confirmed that significant clumping was present during the run and issues with the aim system lighting likely contributed to the low collection efficiency reported for this procedure.The clumping worsened as the run progressed until the collect port was occluded.At 267 minutes into the procedure, the ¿inlet pressure sensor malfunctioned¿ alarm occurred twice.If the inlet line or inlet line trap develops an obstruction or partial occlusion from a skin plug or clot, this can cause the malfunction of the inlet pressure sensor and generate this alarm.In addition, a development of a clot in this location may cause the inlet line to stop drawing entirely, or to draw less fluid into the system because it is blocking the fluid pathway causing fluid balance and other alarms.Additionally, it was noted that the patient gender was changed from female to male at 232 minutes into the run; it was subsequently changed back 15 minutes later.This action is never recommended as it presents a safety issue to the patient with an increase of ac fluid being returned due to the higher total blood volume (tbv) calculated for males versus females.A disposable complaint history search was performed for this lot and found no reports for similar issues on this lot.The customer history report indicates no further related issues have been reported for this customer.The device history records (dhr) were reviewed for this lot.There were no events noted in the dhr that would have contributed to the low collection or entry error experienced by the customer.Correction: retraining was completed by the customer following this incident.Investigation is in process, a follow-up report will be provided.
 
Event Description
The operator found the wbc concentration of collected cells was low after the procedure finished.It was then discovered that the customer changed the gender from female to male at 232 minutes into the procedure.The customer declined to provide the patient identifier.The collection set was not returned because it was discarded by the customer.This product is not available within the us, but this report is being filed due to an alleged failure that could occur on a similarly marketed device platform cleared for use by the fda.
 
Manufacturer Narrative
This report is being filed to provide additional information in h.6 and h.10.Investigation: the run data file (rdf) was analyzed for this event.Review of the rdf and aim images confirmed that significant clumping was present during the run and issues with the aim system lighting likely contributed to the low collection efficiency reported for this procedure.The clumping worsened as the run progressed until the collect port was occluded.At 267 minutes into the procedure, the ¿inlet pressure sensor malfunctioned¿ alarm occurred twice.If the inlet line or inlet line trap develops an obstruction or partial occlusion from a skin plug or clot, this can cause the malfunction of the inlet pressure sensor and generate this alarm.In addition, a development of a clot in this location may cause the inlet line to stop drawing entirely, or to draw less fluid into the system because it is blocking the fluid pathway causing fluid balance and other alarms.Additionally, it was noted that the patient gender was changed from female to male at 232 minutes into the run; it was subsequently changed back 15 minutes later.This action is never recommended as it presents a safety issue to the patient with an increase of ac fluid being returned due to the higher total blood volume (tbv) calculated for males versus females.A disposable complaint history search was performed for this lot and found no reports for similar issues on this lot.The customer history report indicates no further related issues have been reported for this customer.The device history records (dhr) were reviewed for this lot.There were no events noted in the dhr that would have contributed to the low collection or entry error experienced by the customer.Correction: retraining was completed by the customer following this incident.Root cause: a root cause assessment was performed for this complaint.The root cause of the low collection efficiency was determined to be due to significant clumping in the set, causing the collect port to become occluded.Potential causes of clumping include but are not limited to: the inlet/anti-coagulant ratios used in the procedure were inadequate to keep the extracorporeal circuit properly anti-coagulated activation of platelets because of the patient's physiology.The root cause of the potential ac overinfusion was determined to be due to an operator error where they changed the patient gender during the procedure.
 
Event Description
The operator found the wbc concentration of collected cells was low after the procedure finished.It was then discovered that the customer changed the gender from female to male at 232 minutes into the procedure.The customer declined to provide the patient identifier.The collection set was not returned because it was discarded by the customer.This product is not available within the us, but this report is being filed due to an alleged failure that could occur on a similarly marketed device platform cleared for use by the fda.
 
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Brand Name
SPECTRA OPTIA
Type of Device
SPECTRA OPTIA SYSTEM
Manufacturer (Section D)
TERUMO BCT
lakewood CO 80215
Manufacturer (Section G)
TERUMO BCT
10810 w. collins ave
lakewood CO 80215
Manufacturer Contact
scot hilden
10810 w. collins ave
lakewood, CO 80215
MDR Report Key16397779
MDR Text Key309993574
Report Number1722028-2023-00062
Device Sequence Number1
Product Code GKT
Combination Product (y/n)N
Reporter Country CodeCH
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Health Professional
Reporter Occupation Nurse
Type of Report Initial,Followup
Report Date 02/17/2023
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 Catalogue Number10116
Device Lot Number2208293130
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 01/24/2023
Initial Date FDA Received02/17/2023
Supplement Dates Manufacturer Received06/06/2023
Supplement Dates FDA Received06/16/2023
Was Device Evaluated by Manufacturer? No
Date Device Manufactured08/30/2022
Is the Device Single Use? Yes
Is This a Reprocessed and Reused Single-Use Device? No
Type of Device Usage Initial
Patient Sequence Number1
Patient Outcome(s) Other;
Patient Age43 YR
Patient SexFemale
Patient Weight50 KG
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