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

TERUMO BCT SPECTRA OPTIA; SPECTRA OPTIA EXCHANGE SET

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Catalog Number 10220

Device Problems No Apparent Adverse Event (3189); Insufficient Information (3190)

Patient Problems Hypersensitivity/Allergic reaction (1907); Insufficient Information (4580)

Event Date 08/02/2023

Event Type malfunction

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

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.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.Since we did not have pre- and post-ivig infusion data on patient #1, we performed immunoglobulin analysis on another patient (patient #2) undergoing tpe and low-dose ivig infusions for post-transplant focal segmental glomerulosclerosis (fsgs).This is a 49-year-old female, weighing 49 kg, undergoing tpe every 7¿8 days using 5 % albumin as the replacement fluid.She receives 5 g ivig (gammagard® (human immunoglobulin 10 % infusion) or approximately 100 mg/kg of ivig after each tpe.Pre- and post-tpe results demonstrated an igg depletion of between 57 % and 65 % in two consecutive procedures.After low-dose ivig infusion, her levels were still between 28 % and 32 % below her baseline (see table 1).However, the levels did rise above our minimum reportable range of 300 mg/dl.As expected, her levels of iga and igm did not improve with the ivig infusion, as compared to our patient that received tp.We also tested our albumin products (manufactured by shire and grifols), which resulted as 0 mg/dl of iga, igg, and igm.The results from patient #2 suggest that low-dose ivig may be insufficient to maintain baseline levels of igg, post-tpe.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

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.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.

Manufacturer Narrative

This report is being filed to provide additional information in h.6 and h.10.Corrected information is provided in h.6.Investigation: further evaluation of this event has determined that the device did not cause or contribute to a death or serious injury, nor is there a likely potential for death or serious injury associated with this event based on additional investigational information.Since the authors did not have pre- and post-ivig infusion data on patient #1, they performed immunoglobulin analysis on another patient (patient #2) undergoing tpe, and pre-prescribed low-dose ivig infusions for post-transplant focal segmental glomerulosclerosis (fsgs).See report 1722028-2023-00308 for event details.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.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 patients 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.Since we did not have pre- and post-ivig infusion data on patient #1, we performed immunoglobulin analysis on another patient (patient #2) undergoing tpe and low-dose ivig infusions for post-transplant focal segmental glomerulosclerosis (fsgs).This is a 49-year-old female, weighing 49 kg, undergoing tpe every 7-8 days using 5 % albumin as the replacement fluid.She receives 5 g ivig (gammagard (human immunoglobulin 10 % infusion) or approximately 100 mg/kg of ivig after each tpe.Pre- and post-tpe results demonstrated an igg depletion of between (b)(4) consecutive procedures.After low-dose ivig infusion, her levels were still between (b)(4) below her baseline (see table 1).However, the levels did rise above our minimum reportable range of 300 mg/dl.As expected, her levels of iga and igm did not improve with the ivig infusion, as compared to our patient that received tp.We also tested our albumin products (manufactured by shire and grifols), which resulted as 0 mg/dl of iga, igg, and igm.The results from patient #2 suggest that low-dose ivig may be insufficient to maintain baseline levels of igg, post-tpe.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.

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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

17767735

MDR Text Key

323649094

Report Number

1722028-2023-00309

Device Sequence Number

Product Code

LKN

Combination Product (y/n)

Reporter Country Code

PMA/PMN Number

K183081

Number of Events Reported

Summary Report (Y/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

Is this an Adverse Event Report?

Yes

Is this a Product Problem Report?

Yes

Device Operator

Health Professional

Device Catalogue Number

10220

Was Device Available for Evaluation?

Is the Reporter a Health Professional?

Yes

Initial Date Manufacturer Received

08/24/2023

Initial Date FDA Received

09/18/2023

Supplement Dates Manufacturer Received

10/31/2023
11/08/2023
11/29/2023

Supplement Dates FDA Received

11/03/2023
11/28/2023
12/06/2023

Was Device Evaluated by Manufacturer?

Is the Device Single Use?

Yes

Is This a Reprocessed and Reused Single-Use Device?

Type of Device Usage

Initial

Patient Sequence Number

Patient Outcome(s)

Other;

Patient Age

44 YR

Patient Sex

Female

Patient Weight

49 KG

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

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