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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 Problem Adverse Event Without Identified Device or Use Problem (2993)
Patient Problems Low Blood Pressure/ Hypotension (1914); Thrombocytopenia (4431); Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
Event Date 07/17/2021
Event Type  Injury  
Event Description
The journal article "therapeutic plasma exchange in clinical pediatric neurology practice: experience from a tertiary referral hospital" by yildirim et al 2021 was a retrospective study investigated the efficacy, tolerability, and safety of therapeutic plasma exchange (tpe) in children with neuroimmunological disorders.Twenty three patients (60.9% male, mean age = 9.4 yrs) underwent 186 tpe procedures using spectra optia apheresis system.The mean follow up was 27.1 months.No life-threatening complication occurred.Eight patients experienced complications.During the 186 tpe procedures, 13 complications occurred including hypocalcemia (n=2), hypokalemia (n=2), hypophosphatemia (n=1), anemia (n=3), thrombocytopenia (n=1), hypotension (n=2), mild edema of the eyelids and lips (n=1), and urticaria (n=1).Of the 13 complications, 11 were characterized as mild.During the follow up (mean = 27.1 months; range = 2 to 111 months), 5 patients (21.7%) died.The authors stated that ¿no mortality or long-term morbidity due to tpe occurred.¿ the results are reported in sections 3.3 and 3.6.The authors concluded that ¿tpe was found to be effective in children with various types of neuroimmunological disorder and provided an at least mild improvement in approximately 80% of the patients.Moreover, tpe was well-tolerated without life-threatening complications.The moderate complications were anemia necessitating blood transfusion and urticaria.For this event, one patient with myasthenia gravis (mg) experienced hypocalcemia treated with 10% calcium gluconate intravenous infusion, anemia, hypotension and thrombocytopenia during the 1st of 5 therapeutic plasma exchange (tpe) procedures performed on this patient.The disease duration prior to tpe was 14 days.The reported improvement with tpe was reported as moderate.The patient was reported as full recovery after follow-up in 47 months.Patient weight was not provided in the journal article.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.Citation: yildirim, m., bektas, o., botan, e., sahin, s., gurbanov, a., teber, s., & kendirli, t.(2021).Therapeutic plasma exchange in clinical pediatric neurology practice: experience from a tertiary referral hospital.Clinical neurology and neurosurgery, 207, 106823.Https://doi.Org/10.1016/j.Clineuro.2021.106823.
 
Event Description
The journal article "therapeutic plasma exchange in clinical pediatric neurology practice: experience from a tertiary referral hospital" by yildirim et al 2021 was a retrospective study investigated the efficacy, tolerability, and safety of therapeutic plasma exchange (tpe) in children with neuroimmunological disorders.Twenty three patients (60.9% male, mean age = 9.4 yrs) underwent 186 tpe procedures using spectra optia apheresis system.The mean follow up was 27.1 months.No life-threatening complication occurred.Eight patients experienced complications.During the 186 tpe procedures, 13 complications occurred including hypocalcemia (n=2), hypokalemia (n=2), hypophosphatemia (n=1), anemia (n=3), thrombocytopenia (n=1), hypotension (n=2), mild edema of the eyelids and lips (n=1), and urticaria (n=1).Of the 13 complications, 11 were characterized as mild.During the follow up (mean = 27.1 months; range = 2 to 111 months), 5 patients (21.7%) died.The authors stated that ¿no mortality or long-term morbidity due to tpe occurred.¿ the results are reported in sections 3.3 and 3.6.The authors concluded that ¿tpe was found to be effective in children with various types of neuroimmunological disorder and provided an at least mild improvement in approximately 80% of the patients.Moreover, tpe was well-tolerated without life-threatening complications.The moderate complications were anemia necessitating blood transfusion and urticaria.For this event, one patient with myasthenia gravis (mg) experienced hypocalcemia treated with 10% calcium gluconate intravenous infusion, anemia, hypotension and thrombocytopenia during the 1st of 5 therapeutic plasma exchange (tpe) procedures performed on this patient.The disease duration prior to tpe was 14 days.The reported improvement with tpe was reported as moderate.The patient was reported as full recovery after follow-up in 47 months.Patient weight was not provided in the journal article.The collection set is not available for return because it was discarded by the customer.
 
Manufacturer Narrative
Investigation: since this was a journal publication to investigate the efficacy, tolerability, and safety of therapeutic plasma exchange (tpe) in children with neuroimmunological disorders between january 2010 and september 2020, the lot numbers were not requested; therefore, a disposable lot history search or device history record search could not be conducted.All lots must meet acceptance criteria for release.According to therapeutic apheresis: a physician's handbook, with current centrifugal technology, reductions in platelet count are usually modest, and levels quickly return to baseline.In a severely thrombocytopenic patient, however, such a loss may mask the beginning of platelet recovery.Similarly, the small amount of red cells lost in the apheresis circuit may be more apparent in an anemic patient who has meager production capacity and who is receiving multiple procedures.Although generally well tolerated, the large-volume leukocytapheresis for stem cell collections in patients often results in a decline in hematocrit and platelet count, particularly because some red cells and platelets are incidentally removed with the stem cells.According to therapeutic apheresis: a physician's handbook, adverse events occur during therapeutic procedures with a frequency of 4.8%.Some of the most common reactions include fever, urticaria, hypocalcemic symptoms, pruritus, dyspnea, tachycardia, and mild hypotension transient hypocalcemia associated with apheresis is usually well tolerated.Symptoms often show as paresthesia (tingling) but patients may also experience unusual taste, nausea, lightheadedness, shivering, and tremors.Severe hypocalcemia may also cause muscle contractions and can progress to tetany and seizures if hypocalcemia escalates and is not corrected.Citation: yildirim, m., bektas, o., botan, e., sahin, s., gurbanov, a., teber, s., & kendirli, t.(2021).Therapeutic plasma exchange in clinical pediatric neurology practice: experience from a tertiary referral hospital.Clinical neurology and neurosurgery, 207, 106823.Https://doi.Org/10.1016/j.Clineuro.2021.106823 root cause: based on the available information a definitive root cause for the patient reactions could not be determined.Possible causes for the thrombocytopenia could not be determined.Possible causes for a drop in platelet levels may be due to: * processing large volume tbv * dilution effect due to large volume of acda or acda/heparin infused * patient's underlying disease state * clumping in the extracorporeal system * running a lengthy procedure * collect flow rate was set too high possible causes for the alleged hypotension include but are not limited to patient disease state, patient sensitivity to the procedure, the length of the procedure, and/or the hemodynamic stress of the procedure.
 
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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 Key13054071
MDR Text Key282772182
Report Number1722028-2021-00398
Device Sequence Number1
Product Code LKN
UDI-Device Identifier05020583102200
UDI-Public05020583102200
Combination Product (y/n)N
Reporter Country CodeTU
PMA/PMN Number
K183081
Number of Events Reported1
Summary Report (Y/N)N
Report Source Manufacturer
Source Type Foreign,Literature
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 12/21/2021
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 Model Number10220
Device Catalogue Number10220
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Initial Date Manufacturer Received 11/29/2021
Initial Date FDA Received12/21/2021
Supplement Dates Manufacturer Received02/20/2023
Supplement Dates FDA Received03/01/2023
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) Required Intervention;
Patient Age13 YR
Patient SexFemale
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