MAUDE Adverse Event Report: TERUMO BCT COBE SPECTRA; COBE SPECTRA RBCX SET

Model Number 70700

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

Patient Problem Reaction (2414)

Event Date 05/30/2017

Event Type  Injury  

Manufacturer Narrative

Lot number and expiry information are not available at this time investigation: per the article, in this study, the targeted hbs levels (mean level:\30%) were achieved with both machines; however, statistical analysis revealed a significant difference in post-rbcx hbs and fcra levels which were higher with so than with cs.The length of the procedure and replacement volume was statistically significant lower with so.This may have an influence over these results.No clinical implications of these results were observed.The subgroup analysis of the patients who underwent rbcx with both machines did not reveal any statistically significant differences between the pre- and post-rbcx hbs and fcra levels.The only significant difference in this subgroup was found in the post-rbcx platelet count.Although a statistically significant decrease was found in the post-rbcx platelet count with so in both groups, it was not clinically significant.The authors indicated that the rate of adverse events was 4% with a grade of 1¿2 in procedures with both machines.However, they did not specify their grading system and the number of occurrences for each grade.Article citation: buyukkurt, n, et al.2018.Comparative efficacy in red blood cell exchange transfusions with different apheresis machines in patients with sickle cell disease.Indian journal of hematol blood transfusion.(july-sept 2018) 34 (3):495¿500.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, comparative efficacy in red blood cell exchange transfusions with different apheresis machines in patients with sickle cell disease (buyukkurt 2018), as study was conducted on red blood cell exchange procedures.The purpose of the study was to compare the efficacy and side effects of two red blood cell exchange (rbcx) transfusion systems in sickle cell disease (scd).The data was collected retrospectively from the january 2010 to march 2015.Side effects, clinical and technical efficacy were compared in between procedures with cobe spectra (cs) and spectra optia (so) systems.Rbcx transfusions were performed using two different machines operating with a continuous flow apheresis system (cobe spectra version 7 and spectra optia version 7).There were a total of 447 procedures performed in 165 patients; 220 procedures were performed in 92 patients using the cs system and 227 procedures were performed in 113 patients using the so system.Acid citrate dextrose a (acd-a) solution was used in all procedures and whole blood to acd-a ratio was 15:1.The number of patients receiving the procedures using both machines was 40.Most of the procedures were performed due to vasoocclusive crises, preoperative preparation and foot ulcers (49.6, 13 and 15.2% respectively).No severe adverse events or unexpected events were observed during the rbcx procedure using both machines.The rate of adverse events was 4% with a grade of 1¿2 in procedures with both machines.No technical problems related to cell separators was noted in both machines.The post-rbcx platelet count was <100 x 10e9/l in 15 of the patients (9%), but thrombocytopenia was detected in 2 before the rbcx.9 patients had rbcx with cs and the remaining 6 with so.Adverse events noted in cobe spectra: 9 patient reactions involving mild nausea and dizziness with unknown medical intervention 7 patients' platelet counts dropped below <100x10^3/ul (thrombocytopenia) with unknown medical intervention 2 patients with thrombocytopenia before the procedure and later had platelet count dropped below <100x10^3/ul (thrombocytopenia) with unknown medical intervention exact details regarding the patients that experienced reactions, including patient information and outcomes, were not included in the article, therefore, this report is being provided as a summary of the adverse events noted in article.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 b.5, d.4, e.1, h.6 and h.10.Investigation: the purpose of this study is to compare the efficacy and side effects of two red blood cell exchange (rbcx) transfusion systems in sickle cell disease (scd).The data is collected retrospectively from the january 2010 to march 2015.447 rbcx transfusions were performed to 165 patients.Side effects, clinical and technical efficacy were compared in between procedures with cobe spectra (cs) and spectra optia (so) systems.Furthermore a subgroup analyses was performed for 40 patients who had rbcx transfusions with both system at least two times.Vasoocclusive crises, preoperative period and foot ulcers (49.6, 13, and 15.2% respectively) were the common indications of rbcx transfusion.While the levels of post-rbcx hbs and the actual fraction of cells remaining (fcra) were found significantly higher in the so compared to cs system (p = 0.018 and p = 0.016 respectively), the rate of targeted hemoglobin s (hbs) levels (<30%) were same in both.The length of procedure and replacement volume were significantly lower in so compared to cs system (p = 0.025 and 0.044 respectively).Subgroup analyses of 40 patients did not reveal any statistically significant differences regarding post-procedure hbs levels, fcra levels, replacement volume and procedure duration.The inter-rater correlation coefficient for fcra was calculated to be 0.82.Serious adverse reactions were not observed from either system.Both systems are efficiently achieved the targeted post-procedure hbs level.The recently introduced.So apheresis system is as effective and safe as the cs system, which has been used for all indications of scd for years.There were 18 adverse patient reactions alleged in the article linked to the cobe spectra device.There were 9 instances of mild nausea and dizziness with unknown medical intervention, 7 events where the platelet count dropped below <100e3/ul (thrombocytopenia) with unknown medical intervention and 2 patients with thrombocytopenia before the procedure who's platelet count later dropped below <100e3/ul (thrombocytopenia) with unknown medical intervention.According to therapeutic apheresis: a physician's handbook, adverse events occur during therapeutic procedures with a frequency of 4.8%.Transient hypocalcemia associated with apheresis is usually well tolerated.Symptoms often show as parasethesia (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.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.Since this was a retrospective study to compare the efficacy and side effects of two red blood cell exchange (rbcx) transfusion systems in sickle cell disease (scd) from (b)(6) 2015, the lot numbers are unknown; therefore, a dhr search could not be conducted for the reported incident.All lots must meet acceptance criteria for release.The disposable sets were not available for return.Since this was a retrospective study to compare the efficacy and side effects of two red blood cell exchange (rbcx) transfusion systems in sickle cell disease (scd) from january 2010 to march 2015, the lot numbers are unknown.Root cause: a definitive root cause for the patient reactions could not be determined.Possible causes for the suspected citrate reactions include but are not limited to ac management during the procedure, patient disease state, and/or patient sensitivity to anticoagulant.A definitive root cause for the platelet losses could not be determined.Possible causes 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 a definitive root cause for the patient access issue could not be determined.Possible causes include but are not limited to: - restriction of blood flow in the inlet line due to kinks, clamps, or clotting.If catheter is being used, check for blood flow - occluded access vein due to clotting - inlet pump flow rate is too high - access pressure alarm limit is too high for the operating conditions - inlet pump speed too high for rinseback mode - air accumulation in the access saline sterile barrier filter during rinseback - defective access pressure sensor.

Event Description

This was a retrospective study to compare the efficacy and side effects of two red blood cell exchange (rbcx) transfusion systems in sickle cell disease (scd) from (b)(6) 2015 involving 165 patients.There were 59 male and 33 female patients with an age range of 29.3 +/- 9.00 years who underwent procedures on cobe spectra.A request for specific patient information is not feasible.

• Brand Name: COBE SPECTRA
• Type of Device: COBE SPECTRA RBCX SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: scot hilden ; 10810 w. collins ave; lakewood, CO 80215 ; 3032314970
• MDR Report Key: 10414376
• MDR Text Key: 203360542
• Report Number: 1722028-2020-00381
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 35020583707000
• UDI-Public: 35020583707000
• Combination Product (y/n): N
• Reporter Country Code: TU
• 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
• 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: 70700
• Device Catalogue Number: 70700
• 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: 07/26/2022
• Supplement Dates FDA Received: 07/29/2022
• 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): Other