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U.S. Department of Health and Human Services

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

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TERUMO BCT SPECTRA OPTIA; SPECTRA OPTIA EXCHANGE SET,EA Back to Search Results
Model Number 12220
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
Patient Problem Hemolysis (1886)
Event Date 05/30/2023
Event Type  malfunction  
Event Description
The customer reported that they were performing a therapeutic plasma exchange (tpe) using a spectra optia device on a patient with high triglycerides levels.The customer noticed that there appeared to be some hemolysis in the plasma line.Per follow up from the customers doctor the procedure was discontinued as the patient has underlaying issues.When asked by terumo bct support to pause the device and check the fluids, the customer stated that the saline bag was 0.45 % instead of 0.9%.Patient information and outcome are unknown at this time.The collection set is not available for return because it was discarded by the customer.
 
Manufacturer Narrative
Lot number and expiry information are not available at this time.Investigation is in process, a follow-up report will be provided.
 
Manufacturer Narrative
This report is being filed to provide additional information in h.6 and h.10.Investigation: a photograph of the interface through the viewport was provided to tbct clinical support which confirmed the plasma in the connector was red and there was hemolysis.Additionally, a photograph showing an in-date 1l bag of 0.45% usp saline was provided.Lot number and expiry information are not available at this time.Investigation is in process, a follow-up report will be provided.
 
Event Description
The customer reported that they were performing a therapeutic plasma exchange (tpe) using a spectra optia device on a patient with high triglycerides levels.The customer noticed that there appeared to be some hemolysis in the plasma line.Per follow up from the customers doctor the procedure was discontinued as the patient has underlaying issues.When asked by terumo bct support to pause the device and check the fluids, the customer stated that the saline bag was 0.45 % instead of 0.9%.Patient information and outcome are unknown at this time.The collection set is not available for return because it was discarded by the customer.
 
Manufacturer Narrative
Investigation: a photograph of the interface through the viewport was provided to tbct clinical support which confirmed the plasma in the connector was red and there was hemolysis.Additionally, a photograph showing an in-date 1l bag of 0.45% usp saline was provided.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 reported that they were performing a therapeutic plasma exchange (tpe) using a spectra optia device on a patient with high triglycerides levels.The customer noticed that there appeared to be some hemolysis in the plasma line.Per follow up from the customers doctor the procedure was discontinued as the patient has underlaying issues.When asked by terumo bct support to pause the device and check the fluids, the customer stated that the saline bag was 0.45 % instead of 0.9%.Patient information and outcome are unknown at this time.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.10.Investigation: a photograph of the interface through the viewport was provided to tbct clinical support which confirmed the plasma in the connector was red and there was hemolysis.Additionally, a photograph showing an in-date 1l bag of 0.45% usp saline was provided.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: * patient's underlying disease state.Patient's medication and/or medical treatment.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 rbc¿s 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.Hemolysis due to incorrect saline concentration used resulting in a hypotonic environment to the rbcs.
 
Event Description
The customer reported that they were performing a therapeutic plasma exchange (tpe) using a spectra optia device on a patient with high triglycerides levels.The customer noticed that there appeared to be some hemolysis in the plasma line.Per follow up from the customers doctor the procedure was discontinued as the patient has underlaying issues.When asked by terumo bct support to pause the device and check the fluids, the customer stated that the saline bag was 0.45 % instead of 0.9%.Patient information and outcome are unknown at this time.The collection set is not available for return because it was discarded by the customer.
 
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Brand Name
SPECTRA OPTIA
Type of Device
SPECTRA OPTIA EXCHANGE SET,EA
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 Key17190542
MDR Text Key317775160
Report Number1722028-2023-00218
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,Followup
Report Date 06/23/2023
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 Number12220
Device Catalogue Number12220
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 05/30/2023
Initial Date FDA Received06/23/2023
Supplement Dates Manufacturer Received07/19/2023
09/14/2023
12/21/2023
Supplement Dates FDA Received08/11/2023
09/28/2023
12/21/2023
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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