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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
Catalog Number 12220
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
Patient Problem Hemolysis (1886)
Event Date 11/09/2023
Event Type  malfunction  
Event Description
The customer reported that during a therapeutic plasma exchange (tpe) procedure on a spectra optia device, there were many inlet pressure low alarms and return pressure high alarms and that cells were detected in the plasma line from the centrifuge, possible observed hemolysis.The customer stated that the hemolysis was in the return line and plasma was yellow.The solutions were correctly attached and there were no clots in the channel or channel lines.The customer reported that no medical intervention was given and the patient is in stable condition.The collection set is not available for return because it was discarded by the customer.
 
Manufacturer Narrative
Investigation is in process, a follow-up report will be provided.
 
Event Description
The customer reported that during a therapeutic plasma exchange (tpe) procedure on a spectra optia device, there were many inlet pressure low alarms and return pressure high alarms and that cells were detected in the plasma line from the centrifuge, possible observed hemolysis.The customer stated that the hemolysis was in the return line and plasma was yellow.The solutions were correctly attached and there were no clots in the channel or channel lines.The customer reported that no medical intervention was given and the patient is in stable condition.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 h.6 and h.10.Investigation: the customer submitted a photograph to aid the investigation.The photograph shows the signs of hemolysis and there is slight colour variation for the plasma observed.Investigation is in process, a follow-up report will be provided.
 
Event Description
The customer reported that during a therapeutic plasma exchange (tpe) procedure on a spectra optia device, there were many inlet pressure low alarms and return pressure high alarms and that cells were detected in the plasma line from the centrifuge, possible observed hemolysis.The customer stated that the hemolysis was in the return line and plasma was yellow.The solutions were correctly attached and there were no clots in the channel or channel lines.The customer reported that no medical intervention was given and the patient is in stable condition.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.6, h.6 and h.10.Investigation: the customer submitted a photograph to aid the investigation.The photograph shows the signs of hemolysis and there is slight colour variation for the plasma observed.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Investigation is in process, a follow-up report will be provided.
 
Event Description
The customer reported that during a therapeutic plasma exchange (tpe) procedure on a spectra optia device, there were many inlet pressure low alarms and return pressure high alarms and that cells were detected in the plasma line from the centrifuge, possible observed hemolysis.The customer stated that the hemolysis was in the return line and plasma was yellow.The solutions were correctly attached and there were no clots in the channel or channel lines.The customer reported that no medical intervention was given and the patient is in stable condition.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 h.6, h.10 and h.11.Investigation: the customer submitted a photograph to aid the investigation.The first photograph shows a used optia set containing blood throughout loaded on the machine.There is slight color variation in the plasma observed.The second photograph shows blood warmer tubing attached to the device and confirms the presence of hemolysis / plasma discoloration.A third photograph shows the replacement fluid and confirms that the albumin bottle has been vented properly.The last photograph shows the channel connector and it is evident that there is no hemolysis as the plasma is a clear yellow color.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.A disposable complaint history search was performed for this lot and found one report for similar issues on this lot.See mdr 1722028-2023-00263.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: patient's underlying disease state.Patient's medication and/or medical treatment.Hemolysis due to pinched return line resulting in rbc¿s exposed to pressure drop in return line.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 Key18257098
MDR Text Key329613204
Report Number1722028-2023-00405
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 Administrator/Supervisor
Type of Report Initial,Followup,Followup,Followup
Report Date 12/04/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received12/04/2023
Is this an Adverse Event Report? No
Is this a Product Problem Report? Yes
Device Operator Health Professional
Device Catalogue Number12220
Device Lot Number2301243141
Was Device Available for Evaluation? No
Date Manufacturer Received03/22/2024
Was Device Evaluated by Manufacturer? No
Date Device Manufactured01/24/2023
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 Age66 YR
Patient SexFemale
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