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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 4122201
Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
Patient Problems Pain (1994); Insufficient Information (4580)
Event Date 09/05/2022
Event Type  Death  
Manufacturer Narrative
Investigation: 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 a patient was given an red blood cell exchange (rcbx).The patient later deteriorated then passed away.Patient identifier is not available at this time.The exchange set is not available for return for evaluation.This report is being filed due to patient death, though at this time there is not an allegation that the device caused or contributed to the patient death.
 
Manufacturer Narrative
Investigation: a review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.The run data file (rdf) was analyzed for this event.The system appeared to be operating as intended and there were no signals to indicate the device malfunctioned.The customer provided a photograph of the disposable set in lieu of the set return.The photo confirmed the cassette was loaded onto the device and was taken at the end of the procedure.It was not clear if the patient was connected at the time the photo was taken, but there was evidence of blood within the cassette.The blood at the removal side of the kit was noticeably lighter in colour compared to the inlet/return and replace lines.There were no obvious disposable manufacturing defects identified from the photo provided.Investigation is in process.A follow up report will be provided.
 
Event Description
The customer reported that a patient was given an red blood cell exchange (rcbx).The patient later deteriorated then passed away.The exchange set is not available for return for evaluation.This report is being filed due to patient death, though at this time there is not an allegation that the device caused or contributed to the patient death.
 
Event Description
The customer reported that a patient was given an red blood cell exchange (rcbx).The patient later deteriorated then passed away.The exchange set is not available for return for evaluation.This report is being filed due to patient death, though at this time there is not an allegation that the device caused or contributed to the patient death.
 
Manufacturer Narrative
This report is being filed to provide additional information in h.6 and h.10.Investigation: a review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.The run data file (rdf) was analyzed for this event.The system appeared to be operating as intended and there were no signals to indicate the device malfunctioned.The customer provided a photograph of the disposable set in lieu of the set return.The photo confirmed the cassette was loaded onto the device and was taken at the end of the procedure.It was not clear if the patient was connected at the time the photo was taken, but there was evidence of blood within the cassette.The blood at the removal side of the kit was noticeably lighter in colour compared to the inlet/return and replace lines.There were no obvious disposable manufacturing defects identified from the photo provided.The notes provided by the consultant haematologist stated the following regarding the cause of death: the patient developed multi organ failure, (liver, kidneys, lungs and bone marrow) and he received treatment with broad spectrum antibiotics, including specific cover for biliary sepsis.The rapid progression of multi organ failure (within 24hrs of being in hospital) raised the possibility of fat embolism syndrome.The ct abdomen showed: 1.Features suggest acute chest syndrome.2.Mild hepatomegaly with a mild increase in overall attenuation of the liver, which may be related to iron deposition from previous blood transfusions.Very mild hypo attenuation peripherally in the right lobe of the liver and narrowing of the hepatic segment of the ivc and proximal hepatic veins.This of uncertain significance but may be suggestive of possible hepatic veno-occlusive disease.3.Features suggestive of fluid overload (periportal oedema, pericholecystic fluid, small volume ascites and small bilateral pleural effusion notes provided by the pathologist are as follows: the case has been referred to the coroner as we could not definitely confirm the cause of death.Final result still pending histology from autopsy.Macroscopic postmortem (pm) suggested acute chest syndrome but in view of progressive liver and renal dysfunction with metabolic acidosis and being accompanied by laboratory abnormalities indicating a hyperinflammatory response as well as a marked fall in haemoglobin and platelets out of proportion to that typically seen in acute coronary syndrome acs.In the absence of evidence of sepsis this picture is most often caused by bone marrow necrosis with fat embolism in sickle cell disease (scd).The consultant haematologist stated that the autopsy report and the histological samples from the post-mortem could take up to 3 months (~(b)(6)) since the death occurred on (b)(6)2022.The customer declined to provide the autopsy result.A disposable complaint history search was performed for this lot and found no reports for similar issues on this lot worldwide.Root cause: a root cause assessment was performed for this complaint.Based on the available information a definitive root cause could not be determined but it is likely due to the patient's pre-existing disease condition.
 
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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 Key15928792
MDR Text Key304958490
Report Number1722028-2022-00392
Device Sequence Number1
Product Code GKT
Combination Product (y/n)N
Reporter Country CodeUK
PMA/PMN Number
BK150251
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,Followup
Report Date 12/06/2022
1 Device was Involved in the Event
1 Patient was Involved in the Event
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Catalogue Number4122201
Device Lot Number2208016241
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/11/2022
Initial Date FDA Received12/06/2022
Supplement Dates Manufacturer Received12/07/2022
01/20/2023
Supplement Dates FDA Received12/27/2022
01/20/2023
Was Device Evaluated by Manufacturer? No
Date Device Manufactured08/02/2022
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 Age18 YR
Patient SexMale
Patient Weight90 KG
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