MAUDE Adverse Event Report: TERUMO BCT COBE SPECTRA; COBE SPECTRA AUTOPBSC SET, ISBT

Model Number 70610

Device Problem Adverse Event Without Identified Device or Use Problem (2993)

Patient Problems Anemia (1706); Paralysis (1997); Vomiting (2144); Toxicity (2333); Test Result (2695)

Event Date 12/07/2014

Event Type  Injury  

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 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." adverse events occurred during the study: - 3 patients suffered from citrate toxicity, which consisted of perioral paresthesias and one had vomiting.Despite the prophylactic calcium perfusion administered at the beginning of the leukapheresis, an adjusted dose of oral calcium gluconate was immediately given to these children and all had their symptoms resolved.It is unknown if these events occured on the spectra optia or cobe spectra device) - 1 patient with anemia signs and a hemoglobin value of 6.5 g/dl after the first leukapheresis had to be transfused with one adjusted volume, irradiated and leukodepleted packed red blood cells; this patient was transfused once more at the second mobilization.- 2 patients received an irradiated platelet pool (10 ml/ kg) due to moderate thrombocytopenia.- 1 patient needed three platelet transfusions, two of these were in the first mobilization.Exact details (patient information and outcome, platform with which the events were associated) regarding the patients with adverse events 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.

Manufacturer Narrative

This report is being filed to provide additional information in b1 and b2.Investigation is in process.A follow up report will be provided.

Event Description

Within this article, the adverse events that were registered on the cobe spectra were the two patients with thrombocytopenia and one with anemia.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.

Manufacturer Narrative

This report is being filed to provide additional information in b5, e.1, h.6 and h.10.Investigation: per the article, "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." 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.Dhr: this is a retrospective data analysis of 19 children underwent hpc collection between 2003 and 2014, the lot numbers were 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 definitive root cause for the platelet and rbc losses could not be determined.- processing large volume tbv - collecting too dark resulting in rbc losses - use of diluted custom prime rbc resulting in rbc losses - collecting too light resulting in platelet losses - dilution effect due to large volume of acda or acda/heparin infused - use of higher separation factor than recommended - patient's underlying disease state.

• Brand Name: COBE SPECTRA
• Type of Device: COBE SPECTRA AUTOPBSC SET, ISBT
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: scot hilden ; 10810 w collins ave; lakewood, CO 80215 ; 3032314970
• MDR Report Key: 10420244
• MDR Text Key: 203479515
• Report Number: 1722028-2020-00387
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583706101
• UDI-Public: 05020583706101
• Combination Product (y/n): N
• PMA/PMN Number: BK080035
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 08/18/2020

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 08/18/2020
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 70610
• Device Catalogue Number: 70610
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 04/06/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• Is the Device Single Use?: Yes
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Initial
• Patient Sequence Number: 1
• Patient Outcome(s): Required Intervention; Other