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U.S. Department of Health and Human Services

MAUDE Adverse Event Report: TERUMO BCT SPECTRA OPTIA; SPECTRA OPTIA EXCHANGE SET

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TERUMO BCT SPECTRA OPTIA; SPECTRA OPTIA EXCHANGE SET Back to Search Results
Model Number 10220
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
Patient Problem Hemolysis (1886)
Event Date 04/06/2023
Event Type  malfunction  
Manufacturer Narrative
This report is being filed to provide additional information in d.4, h.6 and h.10.Investigation: the customer submitted a photograph of the interface through the viewport to tbct clinical support which confirmed the plasma in the connector was red and there was hemolysis.The lot number was not provided, therefore, a dhr search could not be conducted for this specific incident.All lots must meet acceptance criteria for release.Investigation is in process, a follow-up report will be provided.
 
Event Description
The customer called because at the beginning of the run the system continued to detect cells in the plasma line in the centrifuge.The customer did a blood prime with a hct of 65 and the patient hct of 36.Customer raised the patient's hct to 50.The patient has transverse myelitis and he said the interface was high.The procedure was paused and the physician was notified.Dr.Redwine wanted to continue with the procedure.Patient information is unknown at this time.The patient was reported as stable and did not allege any medical intervention.The collection set is not available for return because it was discarded by the customer.
 
Event Description
The customer called because at the beginning of a therapeutic plasma exchange (tpe) to inform that the system continued to detect cells in the plasma line in the centrifuge.The customer did a blood prime with a hematocrit (hct) of 65% and the patient hct of 36%.The customer raised the patient's hct to 50.The patient has transverse myelitis and he said the interface was high.The procedure was paused and the physician was notified.The doctor wanted to continue with the procedure.Clinical support talked him through pressing disable on the alarm screen.He was trying to continue with the procedure but at this time he was having inlet pressure alarms.Clinical support suggested he lower the inlet flow rate.The patient catheter is in the femoral, they have already tried switching the line.After multiple follow-ups no patient, disposables or additional details were obtained.The patient was reported as stable and did not require any medical intervention.The collection set is not available for return because it was discarded by the customer.
 
Manufacturer Narrative
This report is being filed to provide additional information in b.5, h.6 and h.10.Investigation: the customer submitted a photograph of the interface through the viewport to tbct clinical support which confirmed the plasma in the connector was red and there was hemolysis.The lot number was not provided, therefore, a dhr search could not be conducted for this specific incident.All lots must meet acceptance criteria for release.Root cause: a root cause assessment was performed for this complaint.Based on the available information a definitive root cause for hemolysis could not be determined but it is likely due to one or a combination of the possible causes listed below: hemolysis due to inlet needle replaced with smaller diameter or incompletely broken septum resulting in rbcs exposed to pressure drop in the inlet line.Hemolysis due to inlet needle replaced with smaller diameter or incompletely broken septum resulting in rbcs exposed to pressure drop in the inlet line.Hemolysis due to pinched return line resulting in rbcs exposed to pressure drop in return line.Hemolysis due to pinched inlet line resulting in rbcs exposed to pressure drop in inlet line.The residual total risk is determined to be low.Hemolysis due to an occlusion in the tubing resulting in rbcs exposed to a pressure drop.
 
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Brand Name
SPECTRA OPTIA
Type of Device
SPECTRA OPTIA EXCHANGE SET
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 Key16825238
MDR Text Key337541722
Report Number1722028-2023-00158
Device Sequence Number1
Product Code LKN
Combination Product (y/n)N
Reporter Country CodeUS
PMA/PMN Number
K183081
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup,Followup
Report Date 04/27/2023
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 Model Number10220
Device Catalogue Number10220
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 04/05/2023
Initial Date FDA Received04/27/2023
Supplement Dates Manufacturer Received08/15/2023
12/12/2023
Supplement Dates FDA Received08/28/2023
12/19/2023
Was Device Evaluated by Manufacturer? No
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;
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