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

Model Number 10310

Device Problems Infusion or Flow Problem (2964); Adverse Event Without Identified Device or Use Problem (2993)

Patient Problem Blood Loss (2597)

Event Date 01/04/2016

Event Type  Injury  

Manufacturer Narrative

Lot number and expiry information are not available at this time.Investigation: per the article, during both separation procedures, a statistically significant decrease in hemoglobin levels was observed.While no differences in pre- and post apheresis hemoglobin levels were found between the collection regimens, relative hemoglobin loss levels were significantly higher during continuous apheresis (10%) than during the tow-step collection regimen (8%) among the mm patients (p=0.019).Dilution of the peripheral blood certainly influenced platelet and hemoglobin levels after leukapheresis.The maximum acd infusion rate was set to 1.2 ml/(min l) tbv and the acd/blood ratio was set to 1:12 to 1:15, resulting in a total volume of infused acd of 0.5¿1.5 l (depending on the duration of the apheresis procedure and the blood volume of the patient).1¿2 l of sodium chloride were infused additionally over the duration of 1.5¿5 h of leukapheresis, which further contributed to dilution.Article citation: lisenko, k, pavel, petra, et al.2017.Comparison between intermittent and continuous spectra optia leukapheresis systems for autologous peripheral blood stem cell collection.Journal of clinical apheresis.2017; 32:27¿34.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

Per the article, 'comparison between intermittent and continuous spectra optia leukapheresis systems for autologous peripheral blood stem cell collection', a study was performed to compare continuous mononuclear cell (cmnc) collection and intermittent two-step cell separation on spectra optia, in regard to specific performance parameters.A retrospective data analysis of 150 patients who had undergone peripheral blood stem cell collection between march of 2014 and may of 2015 at their institution was performed.From march to november of 2014, pbsc collection was carried out as a two-step separation procedure (mnc software version 7.2).From november of 2014, a continuous pbsc collection method (mnc software version 11.2) was used.To achieve homogenization, the patients were subdivided into two groups by diagnosis and previous forms of therapy received: a homogeneous subgroup of mm patients (n=88) undergoing first line therapy and a heterogeneous group composed of the rest of the patients (n=62).Overall, 116 (61 two-step, 55 continuous) lp procedures for mm patients and 76 (37 two-step, 39 continuous) lp sessions for patients with other entities were evaluated.The mm and non-mm patients did not show any significant differences in terms of cd341 collection yields for either collection regimen.As a result of the lp process, platelet levels significantly dropped regardless of the diagnosis and collection regimen involved.With both collection regimens, a statistically significant drop of platelets after leukapheresis was observed, but they did not find any significant differences in platelet loss levels between the two regimens.For three patients, a post apheresis platelet count of <20 x 10e9/l was found, and only one patient received a prophylactic platelet transfusion after undergoing apheresis.Patient information for this patient is not available at this time.Per the article, "absolute and relative platelet loss values were similar between the two-step and continuous collection regimens.The two-step system was originally believed to save platelets.However, as maximizing the number of collected cd341 cells is the primary goal at our center, we always adjusted the machines accordingly (max.Time of 300 min.And 43 total blood volume).This may have contributed to this result." (lisenko 2017).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.Investigation: they observed three adverse events.With the two step separation they had one episode with vomiting, hypertension and bronchospasm right after finishing the collection procedure.The patient was transferred to the intensive care unit, recovered quickly and left the hospital a few days later without any residual symptoms.In another case they had to stop the collection procedure due to anxiety and noncompliance of the patient, but could not initiate retransfusion for technical reasons.The asymptomatic patient could leave the hospital a few hours later without any symptoms.With the cmnc system they had one episode of recurrent clotting in the tubing system.The procedure had to be interrupted and a new tubing set was mounted before continuing the collection procedure.They suggested a preexisting condition of hypercoagulopathy in this patient, but could not confirm this with further diagnostics.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 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.Root cause: a definitive root cause for the platelet and rbc losses could not be determined.The authors stated that "dilution of the peripheral blood certainly influenced platelet and hemoglobin levels after leukapheresis.The maximum acd infusion rate was set to 1.2 ml/(min l) tbv and the acd/blood ratio was set to 1:12 to 1:15, resulting in a total volume of infused acd of 0.5¿1.5 l (depending on the duration of the apheresis procedure and the blood volume of the patient).1¿2 l of sodium chloride were infused additionally over the duration of 1.5¿5 h of leukapheresis, which further contributed to dilution." (p.32).In addition, the authors stated that "as maximizing the number of collected cd341 cells is the primary goal at our center, we always adjusted the machines accordingly (max.Time of 300 min.And 43 total blood volume).This may have contributed to this result." (p.33).A definitive root cause for clotting could not be determined.The authors "suggested a preexisting condition of hypercoagulopathy in this patient, but could not confirm this with further diagnostics." (p.32).Possible causes include but are not limited to: - patient's underlying disease state - improper anticoagulation of the extracorporeal system.

Event Description

This is a retrospective data analysis of 150 patients who had undergone peripheral blood stem cell collection at a single institution between march of 2014 and may of 2015.A request for specific patient information is not feasible.Collection regimen two step continuous patient number n=47.N=41 age (years).62 (44¿79).55 (40¿70) male.N=26.N=23 female.N=21.N=18.Body weight (kg).79 (54¿108).80 (54¿118).

• Brand Name: SPECTRA OPTIA
• Type of Device: 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: 10416828
• MDR Text Key: 210002082
• Report Number: 1722028-2020-00384
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583103108
• UDI-Public: 05020583103108
• Combination Product (y/n): N
• PMA/PMN Number: K183081
• Number of Events Reported: 1
• 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: 08/17/2020

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
• Device Operator: Health Professional
• Device Model Number: 10310
• Device Catalogue Number: 10310
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Initial Date Manufacturer Received: 02/01/2019
• Initial Date FDA Received: 08/17/2020
• Supplement Dates Manufacturer Received: 04/06/2022
• Supplement Dates FDA Received: 04/12/2022
• 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