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

Catalog Number 10220

Device Problems Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)

Patient Problems Nausea (1970); Vomiting (2144); Malaise (2359); Insufficient Information (4580)

Event Date 08/02/2023

Event Type  Injury  

Manufacturer Narrative

Lot number and expiry information are not available at this time.Investigation is in process, a follow-up report will be provided.Williams, l. a., thiele, b. a., kinard, t., kaleta, e., adamski, j., su, l., jones, s., & lu, q.(2023).Thawed plasma (tp) as a substitute for intravenous immune globulin (ivig) to prevent hypogammaglobulinemia post-therapeutic plasma exchange. transfusion and apheresis science, 62(4), 103716. https://doi.Org/10.1016/j.Transci.2023.103716.

Event Description

Per journal article "thawed plasma (tp) as a substitute for intravenous immune globulin (ivig) to prevent hypogammaglobulinemia post-therapeutic plasma exchange transfus apher sci, 62(4), 103716" by, williams, l.A., 3rd,thiele, b.A.,kinard, t.,kaleta, e.,adamski, j.,su, l.,jones, s.,lu, q.(2023).Intravenous immune globulin (ivig) is a common treatment given after plasma exchange procedures to either prevent secondary hypogammaglobulinemia or as an adjunctive treatment for organ transplant rejection.However, side-effects are relatively common with this medication during and after infusion.This case-report describes our alternative to ivig infusions post-plasma exchange.We hypothesize that in patients unable to tolerate ivig, using thawed plasma as a replacement fluid provides a suitable increase in the patients post procedure immunoglobulin g (igg) levels for patients with secondary hypogammaglobulinemia that are unable to tolerate ivig infusions.Specific details, such as patient information and outcome, were not included in the article for these events, therefore this report is being provided as a summary of the events.The collection 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 h.6 and h.10.Investigation: part evaluation is not feasible for this journal article investigation because there are many months between collection of data, to peer review, to final publication.This was a journal publication presenting data of a case-report detailing their experience with a patient undergoing chronic tpe.A request for lot numbers is not feasible because there are many months between collection of data, to peer review, to final publication.Therefore, a dhr search could not be conducted for this specific incident.All lots must meet acceptance criteria for release.According to therapeutic apheresis: a physician's handbook, the extent to which tpe depletes a substance from the body is affected by its distribution between intravascular and extravascular compartments.In the course of a single tpe procedure, removal of igm and fibrinogen, which are located predominantly in the intravascular compartment, is more complete than removal of igg, which has a larger extravascular distribution and, therefore, an actual reduction that may not be as great as predicted.Such a result is due to re-equilibration from the extravascular compartment.Lower-molecular-weight compounds that are highly diffusible or subject to active homeostatic regulation in the plasma (eg, calcium, potassium) are removed much less efficiently by tpe, in effect behaving as though their intravascular and extravascular masses are exchanged simultaneously.The return of a substance toward baseline levels, after being depleted by apheresis, is governed by a balance of synthesis, catabolism, and re-equilibration between compartments, although the administration of immunosuppressive drugs may affect the contribution of synthesis to the recovery of immunoglobulins after tpe.Antibody levels decline when tpe is performed with albumin replacement.Although humoral immunodeficiency caused by decreased circulating antibody might logically be predicted in patients receiving numerous treatments, it is rarely observed.Replacement with plasma or intravenous immune globulin (ivig) for the purpose of replenishing lost immunoglobulins is not indicated.Investigation is in process.A follow-up report will be provided.Williams, l. a., thiele, b. a., kinard, t., kaleta, e., adamski, j., su, l., jones, s., & lu, q.(2023).Thawed plasma (tp) as a substitute for intravenous immune globulin (ivig) to prevent hypogammaglobulinemia post-therapeutic plasma exchange. transfusion and apheresis science, 62(4), 103716. https://doi.Org/10.1016/j.Transci.2023.103716.

Event Description

Per journal article "thawed plasma (tp) as a substitute for intravenous immune globulin (ivig) to prevent hypogammaglobulinemia post-therapeutic plasma exchange transfus apher sci, 62(4), 103716" by, williams, l.A., 3rd,thiele, b.A.,kinard, t.,kaleta, e.,adamski, j.,su, l.,jones, s.,lu, q.(2023).Intravenous immune globulin (ivig) is a common treatment given after plasma exchange procedures to either prevent secondary hypogammaglobulinemia or as an adjunctive treatment for organ transplant rejection.However, side-effects are relatively common with this medication during and after infusion.This case-report describes our alternative to ivig infusions post-plasma exchange.We hypothesize that in patients unable to tolerate ivig, using thawed plasma as a replacement fluid provides a suitable increase in the patients post procedure immunoglobulin g (igg) levels for patients with secondary hypogammaglobulinemia that are unable to tolerate ivig infusions.Patient #1 is a 55-year-old female, weighing 82 kg, with myasthenia gravis (mg) undergoing weekly tpe (performed on the spectra optia® ¿ terumo bct, lakewood, co) for maintenance therapy using 5 % albumin as the replacement fluid.During the course of her chronic tpe treatments, we identified low levels of immunoglobulin g (igg).To prevent the negative effects of this secondary hypogammaglobulinemia, the patient initially received low dose ivig infusions post-tpe (gammagard® (human immunoglobulin 10 % infusion) 10 g; approximately 120 mg/kg).The patient tolerated weekly tpe, but experienced severe side-effects (nausea, vomiting, malaise from the ivig infusions lasting 2¿4 days post-infusion.Even with lower doses (5 g), premedications (e.G., diphenhydramine), and slower infusion rates, the side-effects persisted.Therefore, during her next procedure we used tp as the sole replacement fluid and measured igg, iga, and igm levels pre- and post- tpe.As seen in table 1, we found that this strategy provided post-tpe igg levels that were 23 % and 33 % above her baseline igg levels in two back-to-back procedures.Her post-tpe igm and iga levels demonstrated marked improvement over her baseline, and she had no side-effects or transfusion reactions associated with the tp.After this success, we posited that less tp might achieve equilibrium with her baseline igg levels, while minimizing unnecessary exposure to blood products.Therefore, we provided tp: albumin replacement percentages ranging from 43 % to 62 % over the course of six consecutive procedures.Interestingly, we found that tpe using at least 60 % tp as the replacement fluid was sufficient to maintain baseline igg levels post tpe.This strategy allowed us to avoid using 3¿4 units of tp per procedure, thereby minimizing the patient¿s risk for transfusion reactions and transfusion-transmitted infections.Fig.1 tracks her response to varying levels of tp replacement.This was a journal publication presenting data of a case-report detailing their experience with a patient undergoing chronic tpe.A request for further patient information is not feasible because there are many months between collection of data, to peer review, to final publication.The collection 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.7, h.6 and h.10.Investigation: part evaluation is not feasible for this journal article investigation because there are many months between collection of data, to peer review, to final publication.This was a journal publication presenting data of a case-report detailing their experience with a patient undergoing chronic tpe.A request for lot numbers is not feasible because there are many months between collection of data, to peer review, to final publication.Therefore, a dhr search could not be conducted for this specific incident.All lots must meet acceptance criteria for release.According to therapeutic apheresis: a physician's handbook, the extent to which tpe depletes a substance from the body is affected by its distribution between intravascular and extravascular compartments.In the course of a single tpe procedure, removal of igm and fibrinogen, which are located predominantly in the intravascular compartment, is more complete than removal of igg, which has a larger extravascular distribution and, therefore, an actual reduction that may not be as great as predicted.Such a result is due to re-equilibration from the extravascular compartment.Lower-molecular-weight compounds that are highly diffusible or subject to active homeostatic regulation in the plasma (eg, calcium, potassium) are removed much less efficiently by tpe, in effect behaving as though their intravascular and extravascular masses are exchanged simultaneously.The return of a substance toward baseline levels, after being depleted by apheresis, is governed by a balance of synthesis, catabolism, and re-equilibration between compartments, although the administration of immunosuppressive drugs may affect the contribution of synthesis to the recovery of immunoglobulins after tpe.Antibody levels decline when tpe is performed with albumin replacement.Although humoral immunodeficiency caused by decreased circulating antibody might logically be predicted in patients receiving numerous treatments, it is rarely observed.Replacement with plasma or intravenous immune globulin (ivig) for the purpose of replenishing lost immunoglobulins is not indicated.Root cause: a root cause assessment was performed for the reported hypogammaglobulinemia.The authors concluded that the use of albumin products as replacement fluids containing 0 mg/dl of iga, igg, and igm contributed to the patient¿¿¿s hypogammaglobulinemia after undergoing weekly tpe procedure.Williams,¿¿l.¿¿a., thiele,¿¿b.¿¿a., kinard,¿¿t., kaleta,¿¿e., adamski,¿¿j., su,¿¿l., jones,¿¿s., & lu,¿¿q.(2023).Thawed plasma (tp) as a substitute for intravenous immune globulin (ivig) to prevent hypogammaglobulinemia post-therapeutic plasma exchange.¿¿transfusion and apheresis science,¿¿62(4), 103716.¿¿https://doi.Org/10.1016/j.Transci.2023.103716.

Event Description

Per journal article "thawed plasma (tp) as a substitute for intravenous immune globulin (ivig) to prevent hypogammaglobulinemia post-therapeutic plasma exchange transfus apher sci, 62(4), 103716" by, williams, l.A., 3rd,thiele, b.A.,kinard, t.,kaleta, e.,adamski, j.,su, l.,jones, s.,lu, q.(2023).Intravenous immune globulin (ivig) is a common treatment given after plasma exchange procedures to either prevent secondary hypogammaglobulinemia or as an adjunctive treatment for organ transplant rejection.However, side-effects are relatively common with this medication during and after infusion.This case-report describes our alternative to ivig infusions post-plasma exchange.We hypothesize that in patients unable to tolerate ivig, using thawed plasma as a replacement fluid provides a suitable increase in the patients post procedure immunoglobulin g (igg) levels for patients with secondary hypogammaglobulinemia that are unable to tolerate ivig infusions.Patient #1 is a 55-year-old female, weighing 82 kg, with myasthenia gravis (mg) undergoing weekly tpe (performed on the spectra optia¿¿ ¿¿¿ terumo bct, lakewood, co) for maintenance therapy using 5 % albumin as the replacement fluid.During the course of her chronic tpe treatments, we identified low levels of immunoglobulin g (igg).To prevent the negative effects of this secondary hypogammaglobulinemia, the patient initially received low dose ivig infusions post-tpe (gammagard¿¿ (human immunoglobulin 10 % infusion) 10 g; approximately 120 mg/kg).The patient tolerated weekly tpe, but experienced severe side-effects (nausea, vomiting, malaise from the ivig infusions lasting 2¿¿¿4 days post-infusion.Even with lower doses (5 g), premedications (e.G., diphenhydramine), and slower infusion rates, the side-effects persisted.Therefore, during her next procedure we used tp as the sole replacement fluid and measured igg, iga, and igm levels pre- and post- tpe.As seen in table 1, we found that this strategy provided post-tpe igg levels that were 23 % and 33 % above her baseline igg levels in two back-to-back procedures.Her post-tpe igm and iga levels demonstrated marked improvement over her baseline, and she had no side-effects or transfusion reactions associated with the tp.After this success, we posited that less tp might achieve equilibrium with her baseline igg levels, while minimizing unnecessary exposure to blood products.Therefore, we provided tp: albumin replacement percentages ranging from 43 % to 62 % over the course of six consecutive procedures.Interestingly, we found that tpe using at least 60 % tp as the replacement fluid was sufficient to maintain baseline igg levels post tpe.This strategy allowed us to avoid using 3¿¿¿4 units of tp per procedure, thereby minimizing the patient¿¿¿s risk for transfusion reactions and transfusion-transmitted infections.Fig.1 tracks her response to varying levels of tp replacement.This was a journal publication presenting data of a case-report detailing their experience with a patient undergoing chronic tpe.A request for further patient information is not feasible because there are many months between collection of data, to peer review, to final publication.The collection set is not available for return because it was discarded by the customer.

Event Description

Per journal article "thawed plasma (tp) as a substitute for intravenous immune globulin (ivig) to prevent hypogammaglobulinemia post-therapeutic plasma exchange transfus apher sci, 62(4), 103716" by, williams, l.A., 3rd,thiele, b.A.,kinard, t.,kaleta, e.,adamski, j.,su, l.,jones, s.,lu, q.(2023).Intravenous immune globulin (ivig) is a common treatment given after plasma exchange procedures to either prevent secondary hypogammaglobulinemia or as an adjunctive treatment for organ transplant rejection.However, side-effects are relatively common with this medication during and after infusion.This case-report describes our alternative to ivig infusions post-plasma exchange.We hypothesize that in patients unable to tolerate ivig, using thawed plasma as a replacement fluid provides a suitable increase in the patients post procedure immunoglobulin g (igg) levels for patients with secondary hypogammaglobulinemia that are unable to tolerate ivig infusions.Specific details, such as patient information and outcome, were not included in the article for these events, therefore this report is being provided as a summary of the events.The collection set is not available for return because it was discarded by the customer.

Manufacturer Narrative

This report is being filed to provide investigation: part evaluation is not feasible for this journal article investigation because there are many months between collection of data, to peer review, to final publication.According to therapeutic apheresis: a physician's handbook, the extent to which tpe depletes a substance from the body is affected by its distribution between intravascular and extravascular compartments.In the course of a single tpe procedure, removal of igm and fibrinogen, which are located predominantly in the intravascular compartment, is more complete than removal of igg, which has a larger extravascular distribution and, therefore, an actual reduction that may not be as great as predicted.Such a result is due to re-equilibration from the extravascular compartment.Lower-molecular-weight compounds that are highly diffusible or subject to active homeostatic regulation in the plasma (eg, calcium, potassium) are removed much less efficiently by tpe, in effect behaving as though their intravascular and extravascular masses are exchanged simultaneously.The return of a substance toward baseline levels, after being depleted by apheresis, is governed by a balance of synthesis, catabolism, and re-equilibration between compartments, although the administration of immunosuppressive drugs may affect the contribution of synthesis to the recovery of immunoglobulins after tpe.Antibody levels decline when tpe is performed with albumin replacement.Although humoral immunodeficiency caused by decreased circulating antibody might logically be predicted in patients receiving numerous treatments, it is rarely observed.Replacement with plasma or intravenous immune globulin (ivig) for the purpose of replenishing lost immunoglobulins is not indicated.This was a journal publication presenting data of a case-report detailing their experience with a patient undergoing chronic tpe.A request for lot numbers is not feasible because there are many months between collection of data, to peer review, to final publication.Therefore, a dhr search could not be conducted for this specific incident.All lots must meet acceptance criteria for release.Investigation is in process, a follow-up report will be provided.Williams, l. a., thiele, b. a., kinard, t., kaleta, e., adamski, j., su, l., jones, s., & lu, q.(2023).Thawed plasma (tp) as a substitute for intravenous immune globulin (ivig) to prevent hypogammaglobulinemia post-therapeutic plasma exchange. transfusion and apheresis science, 62(4), 103716. https://doi.Org/10.1016/j.Transci.2023.103716.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA EXCHANGE SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer (Section G): TERUMO BCT; 10810 w. collins ave; lakewood CO 80215
• Manufacturer Contact: scot hilden ; 10810 w. collins ave; lakewood, CO 80215
• MDR Report Key: 17767745
• MDR Text Key: 323649149
• Report Number: 1722028-2023-00308
• Device Sequence Number: 1
• Product Code: LKN
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: K183081
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Literature
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup,Followup
• Report Date: 09/18/2023

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/18/2023
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Catalogue Number: 10220
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Date Manufacturer Received: 11/29/2023
• Was Device Evaluated by Manufacturer?: No
• 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
• Patient Age: 55 YR
• Patient Sex: Female
• Patient Weight: 82 KG