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

Model Number 10310

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

Patient Problems Pulmonary Embolism (1498); Anemia (1706)

Event Date 01/01/2020

Event Type  Injury  

Manufacturer Narrative

Lot number and expiry information are not available at this time.Investigation: according to the article, "rbc exchange is the primary treatment for scd patients presenting with stroke-like symptoms.However, in the setting of hyerhemolysis syndrome, rbc transfusion (simple or exchange) should be avoided in favor of immunosuppression, to prevent further immune stimulation and hemolysis." article citation: hermelin, d., starr, d., blackall, d.Hyperhemolysis syndrome following red cell exchange in a newly diagnosed sickle cell disease patient with spinal cord infarction.Journal of clinical apheresis.2020.35:555 investigation is in process.A follow-up report will be provided.

Event Description

In the abstract, "hyperhemolysis syndrome following red cell exchange in a newly diagnosed sickle cell disease patient with spinal cord infarction", the authors present a unique case of a 36- year-old african-american (aa) woman, newly diagnosed with sickle cell disease (scd), who received two rbc exchanges during her hospitalization.A (b)(6) woman presented to the emergency department with a 3- day history of nausea, vomiting, and abdominal and back pain.She acutely developed weakness and numbness in her lower extremities.An mri exam showed evidence of a spinal cord infarction.Because of this unusual finding, capillary hb electrophoresis was performed and showed an abnormal pattern consistent with hbs-b+ thalassemia (hbs= 71.4%, hba= 19%, hba2= 6.3%, hbf= 3.2%).Hematology/oncology requested urgent rbc exchange.Pretransfusion testing demonstrated anti-e antibodies.The dat was negative.Rbc exchange was performed using c, e and k antigen-negative units that were hbsnegative (spectra optia® apheresis system).The postexchange hbs was 17.4% and the hb was 10.0 g/dl.Surprisingly, two weeks after the exchange, blood bank testing demonstrated additional antibodies to the fyb, jkb, c, and k antigens.However, the dat continued to be negative.With a rising hbs (45%) and pending discharge, a request for an additional rbc exchange was performed using c, e, fyb, jkb , and k antigen-negative units of blood that were hbs-negative.The post-exchange hbs was 16.0% with a hb of 9.6 g/dl.Ten days after discharge, the patient presented to an affiliated hospital with new-onset chest pain, bilateral pulmonary emboli, and severe anemia (h/h 5.3/17.1).Her hbs was 64.8%.In addition to the previously identified alloantibodies, she now had a reactive dat as well as a warm autoantibody with relative specificity for the d-antigen.These findings were most consistent with hyperhemolysis syndrome.The precipitous rise in hbs% was a reflection of an absolute reduction in transfused hba-positive rbcs secondary to a delayed hemolytic transfusion reaction.At that point, the authors advised against a third exchange transfusion.They recommended judicious transfusion, introduction of an erythropoietinstimulating agent, and an immunosuppressive agent.High-dose steroids and epoetin alfa were provided.The patient was transferred to a hospital with a comprehensive sickle cell center.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, e.1, h.6 and h.10.Investigation: 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.The disposable set was not available for return.A lot history search could not be performed since the disposable lot number remains unknown.Attempts were made to request disposable and device information, but no response was provided by the author of the article.Per the aabb therapeutic apheresis: a physician's handbook, the rate of adverse events during therapeutic apheresis is 4-5%, with most complications being minor and well tolerated.Per the handbook, erythrocytapherisis reactions occur with a 10.0% frequency.Per 2017 aabb circulation of information, delayed hemolytic reactions occur in previously red-cell-alloimmunized patients in whom antigens on transfused red cells provoke amamnestic production of antibody.The amamnestic response reaches a significant circulating level while the transfused cells are still present in the circulation; the usual time frame is 2 to 14 days after transfusion.Signs may include unexplained fever, development of a positive dat result, and unexplained decrease in hemoglobin/hematocrit.Hemolytic transfusion reactions in patients with sickle cell anemia may be particularly severe, with destruction of autologous as well as transfused red cells, resulting in a lower hemoglobin level after transfusion.This is suggestive of hyperhemolysis syndrome.Immediate treatment may include steroid use, ivig, and avoiding transfusions if possible.Root cause: based on the author's conclusions, the direct antiglobulin tests (dat) performed on the patient confirmed that she had developed antibodies against the donor red blood cells.These findings were most consistent with hyperhemolysis syndrome.The precipitous rise in hbs% was a reflection of an absolute reduction in transfused hba-positive rbcs secondary to a delayed hemolytic transfusion reaction.

Event Description

The journal article author did not respond to multiple attempt to obtain further information.No information was provided by the journal article with regard to patient id, weight, or outcome.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA IDL SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 11527716
• MDR Text Key: 252357231
• Report Number: 1722028-2021-00118
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583103108
• UDI-Public: 05020583103108
• Combination Product (y/n): N
• PMA/PMN Number: BK150251
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: health professional,literatur
• Type of Report: Initial,Followup
• Report Date: 03/19/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/19/2021
• 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
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 04/29/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other; Required Intervention