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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 Problems Fever (1858); Tachycardia (2095)
Event Date 04/26/2023
Event Type  Injury  
Event Description
Per the journal article "hpc(a) collection in low-weight pediatric patients.Journal of clinical apheresis." by weidner, k.,dandoy, and c.,alquist, c.R.Adverse reactions were limited to tachycardia in two collections, accompanied by a fever in one case.Specific details, such as patient information and outcome, were not included in the article for these events, therefore this report is being provided as a summary of the events.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.Special issue abstracts from the american society for apheresis 44th annual meeting april 26¿28, 2023.(2023).Journal of clinical apheresis, 38(3), 315.Https://doi.Org/10.1002/jca.22049.
 
Event Description
Per the journal article "hpc(a) collection in low-weight pediatric patients.Journal of clinical apheresis." by weidner, k.,dandoy, and c.,alquist, c.R.Adverse reactions were limited to tachycardia in two collections, accompanied by a fever in one case.An investigation was conducted for a journal publication presenting data of a retrospective analysis of clinical and hpc collection data from autologous and allogeneic pediatric donors weighing <25 kg collected on spectra optia platform using the continuous mononuclear cell collection (cmnc) program from 2020 through 2022.Adverse reactions were limited to tachycardia in two collections, accompanied by a fever in one case.Specific details, such as patient information and outcome, were not included in the article for these events, therefore this report is being provided as a summary of the events.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, e.1, h.6 and h.10.Investigation: purpose: hematopoietic progenitor cell (hpc) collection by apheresis, as opposed to bone marrow harvest, in pediatric patients, may be less invasive and allow faster recovery times, but adequate cell dose collections may be challenging in low-weight weight donors.Several technical modifications can aid successful apheresis collection efforts.Methods: we retrospectively analyzed clinical and hpc collection data from autologous and allogeneic pediatric donors weighing <25 kg collected at our local pediatric medical center from 2020 through 2022.All collections were performed with the spectra optia platform using the continuous mononuclear cell collection (cmnc) program via a central line after either granulocyte-colony stimulating factor (g-csf) or chemo-mobilization.Data included donor weight, pre-procedural peripheral blood (pb) cd34+ cell counts, total and whole blood processed volumes (tbv, wbpv), total cd34+ collection results, blood prime information, anticoagulant (ac) ratios, peri-procedural labs, calcium repletion, sedation approaches, and child-life service interventions for peri-procedural anticipatory guidance and comfort.Results: we reviewed 26 hpc collections in 23 donors weighing an average of 14.9 kg [5.4-23.5kg).One collection was from an allogeneic donor.Pre-collection viable pb cd34 cell counts averaged 310 cells/ul [2-2681 cell/ ul].Wbpv and number of tbv per procedure day averaged 8.9l [4.5-19l] and 7 [6-8], respectively.Each collection utilized a custom rbc prime, an initial inlet ac ratio of 15:1 or 12:1 with an initial ac infusion rate of >1.2 (dependent on inlet pump speed), followed by a platelet count-based ramp, and a weight ¿based calcium monitoring and repletion strategy.Additionally, sedation was reserved for select patients that could not be actively distracted or managed by child-life services or caregivers.Targeted cell dose of 5-20 x 10^6 cd34/recipient kg were met for each patient over 1 to 3 procedures.Twenty-one donor collections were completed in 1 day.Adverse reactions were limited to tachycardia in two collections, accompanied by a fever in one case.Conclusion: apheresis collection of hpcs from low weight donors (<25 kg) can be successfully completed via altered collection parameters, laboratory monitoring, and the involvement of the interdisciplinary team.Since this was a journal publication presenting data of a retrospective analysis of clinical and hpc collection data from autologous and allogeneic pediatric donors weighing <25 kg collected on spectra optia platform using the continuous mononuclear cell collection (cmnc) program from 2020 through 2022, the lot numbers were not requested; therefore, a disposable lot history search could not be conducted.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.Special issue abstracts from the american society for apheresis 44th annual meeting april 26¿28, 2023.(2023).Journal of clinical apheresis, 38(3), 315.Https://doi.Org/10.1002/jca.22049 root cause: a root cause assessment was performed for the adverse reactions (tachycardia).The reported adverse reactions are common side effects of therapeutic apheresis procedures.They are typically caused by fluid shift, blood loss, length of the procedure, patient's sensitivity to the procedure and/or hemodynamic stress of the procedure.A root cause assessment was performed for the adverse reactions (fever).Based on the available information a definitive root cause could not be determined but it is likely due to one or a combination of the possible causes listed below: patient¿s reactions to the mobilization regimen.Patient¿s underlying disease state.
 
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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 Key17321575
MDR Text Key319101298
Report Number1722028-2023-00234
Device Sequence Number1
Product Code LKN
UDI-Device Identifier05020583102200
UDI-Public05020583102200
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 Literature,Health Professional
Reporter Occupation Other Health Care Professional
Type of Report Initial,Followup
Report Date 07/13/2023
1 Device was Involved in the Event
1 Patient was Involved in the Event
Date FDA Received07/13/2023
Is this an Adverse Event Report? Yes
Is this a Product Problem Report? No
Device Operator Health Professional
Device Model Number10220
Device Catalogue Number10220
Device Lot NumberNOT PROVIDED
Was Device Available for Evaluation? No
Is the Reporter a Health Professional? Yes
Date Manufacturer Received08/28/2023
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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