MAUDE Adverse Event Report: TERUMO BCT SPECTRA OPTIA; SPECTRA OPTIA IDL SET

Model Number	10120
Medical Device Problem Code	Self-Activation or Keying (1557)
Health Effect - Clinical Code	Death (1802)
Date of Event	12/07/2014
Type of Reportable Event	Death
Additional Manufacturer Narrative
Lot number and expiry information are not available at this time.Article citation: spinola, a, ferreira, s, et al.2016.Hematopoietic progenitor cells collection in pediatric patients with brain tumor.Journal of clinical apheresis 2016; 31:22¿28.Investigation is in process.A follow-up report will be provided.This report was filed beyond the 30-day timeframe due to an internal processing error.An internal capa has been initiated to address the issue.
Event or Problem Description
The article, 'hematopoietic progenitor cells collection in pediatric patients with brain tumor' (spinola 2016), describes a series of 19 pediatric patients with brain tumors who underwent hematopoietic progenitor cell collections with spectra optia (n=10) and cobe spectra (n=9).The study was done to analyze the efficacy and safety of hematopoietic progenitor cells (hpc) collections by leukapheresis in pediatric patients with brain tumors."between 2003 and 2014, we collected hpc from 19 children (12 boys/7 girls), median age at the diagnosis of 5 years old (<1¿15 years old) and weight of 16.8 kg (6.7¿42).Diagnoses were medulloblastoma (n510), primitive neuroectodermal tumor (n55), atypical teratoid rhabdoid tumor (n53) and secreting germ cell tumor (n51).All patients performed leukapheresis by a central venous catheter, at the fifth day of mobilization with g-csf (median dose 11.7 mg/kg/day), 9 of them with cobe spectra and 10 with spectra optia.The anticoagulant used was acd- a, ratio of 14:1 or acd-a plus heparin, ratio 25:1.The tubing set was primed with a compatible, irradiated, leukodepleted and hematocrit adjusted packed red cells for all children <30 kg (n517).A median of 1.5 (1¿3) leukapheresis per patient was performed with an average of 3 (1.5¿5.4) blood volumes processed; 3 children did a second mobilization and one additional leukapheresis.The median number of cd341 cells collected was 4.6 3 106/kg (0.18¿22.6) of patient body weight; 12 children collected for a tandem transplant.The median time between cell collection and infusion was 3 (0.6¿9.1) months." two patients who received hpc single transplant died 8 and 52 months after transplant.The article did not specify the associated platform (optia or cobe spectra therefore the deaths are being reporting under the optia).Exact details and patient information regarding the patient deaths were not provided in the article, therefore this report is being provided as a summary of the events.The disposable set is not available for return because it was discarded by the customer.This report is being filed due to patient death, though it is not alleged that the device caused or contributed to the death.
Additional Manufacturer Narrative
Investigation: per the article, "all patients performed leukapheresis by a central venous catheter, at the fifth day of mobilization with g-csf (median dose 11.7 mg/kg/day), 9 of them with cobe spectra and 10 with spectra optia.The collections performed in the cobe spectra were done with a semiautomatic mode: the interface was monitored by the operator and the collection flow rate was continuous at 1 ml/min.The separator spectra optia was used with the mnc protocol, which includes an automatic interface management system and collection cycles being triggered without operative intervention.Until january 2013, they used citrate at a constant ratio; after an adverse event during a leukapheresis in a low weight pediatric patient (multiple clots in the tubing set), they decided to perform in all children with less than 30 kg a citrate ramping.The anticoagulant used was acd-a, ratio of 14:1 or acd-a plus heparin, ratio 25:1.This anticoagulation method consists of processing the patient¿s blood volume with a ratio of 1:8 and gradually progressing to 1:14.During this anticoagulation phase, a 10% calcium gluconate 1 ml/kg was given intravenously for one hour to prevent hypocalcemia.The choice of citrate alone or in combination with heparin was based on a careful individual, case by case, risk benefit analysis.Children with increased bleeding risk, past history of moderate to severe hemorrhagic events, recent central nervous system surgery (<3 months prior leukapheresis) and peripheral platelet count <100 x 10^3/ml were considered for citrate alone.Previous and following the apheresis procedure, a complete blood count and electrolyte panel (na1, k1, ca21, mg21) was performed.Transfusion requirement was clinically and analytically evaluated: if an increased hemorrhagic risk was present and a platelet count <100 x 10^3/ml, a platelet pool was given to the child; if signs or symptoms of anemia occurred or hemoglobin level <7.5 g/dl, a packed red blood cell unit was infused.The tubing set was primed with a compatible, irradiated, leukodepleted and hematocrit adjusted packed red cells for all children <30 kg (n=17).The priming of the extracorporeal circuit was made with a compatible, irradiated, leukodepleted packed red cell in children weighing <30 kg.The hematocrit of a 42-day stored red blood cell unit is 55¿60%; so, it must be adjusted to the child hematocrit by dilution with a predetermined volume of saline (a) in a sterile laminar flow chamber.Knowing the red blood cell unit volume (b) and its hematocrit (c), as well as the child hematocrit (d), the volume of the diluted packed red blood cell unit (e) can be calculated by the formula: e5(b x c)/d.The total volume of saline to be added is calculated as followed: a=e ¿ b.A median of 1.5 (1¿3) leukapheresis per patient was performed with an average of 3 (1.5¿5.4) blood volumes processed; 3 children did a second mobilization and one additional leukapheresis.The median number of cd34 cells collected was 4.6 3 10^6/kg (0.18¿22.6) of patient body weight; 12 children collected for a tandem transplant.The median time between cell collection and infusion was 3 (0.6¿9.1) months." the customer did not provide the lot number pertaining to this event, therefore a device history record (dhr) search could not be conducted for this specific incident.All lots must meet acceptance criteria before release.Terumo bct medical safety concluded that, based on the clinical and investigation findings in this publication, the cobe spectra and spectra optia electromechanical devices and disposable sets performed as intended, there were no suggested device failures, malfunctions, mislabeling, improper or inadequate design or manufacturing errors.The two deaths noted in this report were not temporally related to the leukapheresis procedures and were likely due to the patient¿s underlying complex medical condition related to their brain tumor or complications related to their stem cell transplant.The non-serious complications noted in this report are well known adverse events identified in the product labeling for the cobe spectra and spectra optia devices.Root cause: a definitive root cause for the patient death could not be determined.Possible causes include but are not limited to: patient's underlying disease - failure of graft engraftment.
Event or Problem Description
This is a retrospective data analysis of 19 children underwent hpc collection between 2003 and 2014, 12 boys and 7 girls.The median age at the leukapheresis was 5 years old (range, <1¿15 years old) and median weight of 16.8 kg (range, 6.7-42 kg); 17 patients had less than or equal to 30 kg and three of them less than or equal to 10 kg.A request for specific patient information is not feasible.

• Brand Name: SPECTRA OPTIA
• Common Device Name: SPECTRA OPTIA IDL SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: scot hilden ; 10810 w collins ave; lakewood, CO 80215 ; 3032314970
• MDR Report Key: 10420502
• Report Number: 1722028-2020-00391
• Device Sequence Number: 3859860
• Product Code: LKN
• UDI-Device Identifier: 05020583101203
• UDI-Public: 05020583101203
• Combination Product (Y/N): N
• PMA/510(K) Number: K183081
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Literature,Health Professional
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 08/18/2020

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
• Operator of Device: Health Professional
• Device Model Number: 10120
• Device Catalogue Number: 10120
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 02/01/2019
• Supplement Date Received by Manufacturer: 04/06/2022
• Initial Report FDA Received Date: 08/18/2020
• Supplement Report FDA Received Date: 04/14/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown