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

Model Number 10310

Device Problems Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)

Patient Problems Headache (1880); Pain (1994)

Event Date 03/01/2017

Event Type  Injury  

Event Description

The article, 'increased serum pro-b-type natriuretic peptide in hematopoietic progenitor cell donors stimulated with g-csf' describes a study of eighteen healthy donors who underwent a mobilization regimen of 10 g/kg granulocyte-colony stimulating factor (g-csf) daily for 5 days prior to allogeneic (hematopoietic stem cell) hpc collection using spectra optia between january 2016 and february 2017.Serum probnp (pro-b-type natriuretic peptide), a serum marker of heart failure, levels were measured before and after g-csf stimulation and immediately after apheresis.The majority of donors (86.7%) had post-g-csf elevation of serum probnp.Seven of those had elevated probnp above upper normal range (124 pg/ml).The subgroup of donors with normal probnp is younger (median age of 37 vs 42 years), with majority being male (90.9% vs 28.6%) and with smaller processed blood volume (2.2 vs 3 x total blood volume).Per the article, "donors were evaluated after receiving g-csf for hpc mobilization.The symptoms were graded as: mild¿no medication needed, moderate¿pain responded to medication (nonsteroid anti-inflammatory drugs [nsaids] or oxycodone), and severe¿when pain did not respond to medication (nsaid or oxycodone)." donors characteristics: n (%) (total n = 18) sex: male 12 (66.7%) female 6 (33.3%) age (years) median = 38 (range: 21-58) bmi median = 29 (range: 20.9-38.1) race white 10 (55.6%) black 2 (11.1%) hispanic 6 (33.3%) processed volume median = 2.6 (range: 1.5-5.9) (fold of tbv) baseline probnp median = 24 (range: 5-64) (pg/ml) (n = 15) post-g-csf symptoms severe 3 (16.7%) moderate 2 (11.1%) mild 13 (72.2%) of the 18 donors, the index donor that resulted in the initiation of the study was a healthy donor, 41 years old, female.During the apheresis procedure, she complained of intractable headache, photophobia and nausea; however, her vitals remained stable, with pre-procedure blood pressures of 113/74 mmhg vs post-procedure 113/76 mmhg.She was counseled and discharged with a dose of oxycodone (5 mg).However, her symptoms worsened and she presented to the emergency department (ed) 5 h after completion of her donation.She reported ¿the worst headache in my life¿ at the ed, and she also appeared to be dyspneic.Her blood pressure at ed was elevated to 131/78 mmhg, heart rate was 90 beats per minute.Head ct was negative for hemorrhage or mass effect.Laboratory findings included several signs associated with gcsf mobilization and apheresis, such as leukocytosis, decreased platelets, increased alkaline phosphatase (257 u/l [reference range 35-105 u/l]) and transaminases (ast 53 u/l) (range < 31 u/l) and alt 50 u/l (range < 33 u/l), in addition to markedly elevated serum probnp at 483 pg/ml (normal <125 pg/ml for <75 year old), despite no other clinical evidence of cardiac insufficiency or pulmonary abnormalities.Her chest x-ray and echocardiogram were within normal limits.Her other laboratory results showed normal kidney function (bun/creatinine ratio of 9, normal 5-20), troponin t < 0.01 ng/ml.Treatment for symptoms is not specified in the article.Further details regarding patient information or recovery from events is not provided in the article, therefore this report is being provided as a summary.The device is not available for return for evaluation.

Manufacturer Narrative

Investigation: per the article, " serum probnp levels (roche cobas 6000 analyzer) were measured before g-csf stimulation, after 5-days of g-csf stimulation, both prior to and immediately after apheresis procedure.For four healthy donors who returned to have postcollection follow-up more than 7 days after apheresis collection, serum probnp levels were also measured." the authors conclude the case series demonstrates an increase of serum probnp can be common in hpc donors stimulated with 5 days of 10 mcg/kg g-csf.The authors note that this is an adverse reaction that has not been described before.The temporary elevation of probnp in these donors is not associated with ventricular dysfunction of the heart.Article citation: chen, l.N., c montemayor-garcia, ka west-mitchell, cc cantilena.Increased serum pro-b-type natriuretic peptide in hematopoietic progenitor cell donors stimulated with g-csf.Journal of clinical apheresis.2022; 1-6.Doi: 10.1002/jca.21979 investigation is in process.A follow up report will be provided.

Manufacturer Narrative

This report is being filed to provide additional information in h.6 and h.10.Investigation: per the article, " serum probnp levels (roche cobas 6000 analyzer) were measured before g-csf stimulation, after 5-days of g-csf stimulation, both prior to and immediately after apheresis procedure.For four healthy donors who returned to have postcollection follow-up more than 7 days after apheresis collection, serum probnp levels were also measured." the authors conclude the case series demonstrates an increase of serum probnp can be common in hpc donors stimulated with 5 days of 10 mcg/kg g-csf.The authors note that this is an adverse reaction that has not been described before.The temporary elevation of probnp in these donors is not associated with ventricular dysfunction of the heart.Article citation: chen, l.N., c montemayor-garcia, ka west-mitchell, cc cantilena.Increased serum pro-b-type natriuretic peptide in hematopoietic progenitor cell donors stimulated with g-csf.Journal of clinical apheresis.2022; 1-6.Doi: 10.1002/jca.21979 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.It was confirmed that this event is a non-complaint because the authors stated that all the adverse reactions were a result of g-csf and had nothing to do with tbct device.No further reporting will be provided as this does not represent a reportable event.

Event Description

The article, 'increased serum pro-b-type natriuretic peptide in hematopoietic progenitor cell donors stimulated with g-csf' describes a study of eighteen healthy donors who underwent a mobilization regimen of 10 ¿g/kg granulocyte-colony stimulating factor (g-csf) daily for 5 days prior to allogeneic (hematopoietic stem cell) hpc collection using spectra optia between january 2016 and february 2017.Serum probnp (pro-b-type natriuretic peptide), a serum marker of heart failure, levels were measured before and after g-csf stimulation and immediately after apheresis.The majority of donors (86.7%) had post-g-csf elevation of serum probnp.Seven of those had elevated probnp above upper normal range (124 pg/ml).The subgroup of donors with normal probnp is younger (median age of 37 vs 42 years), with majority being male (90.9% vs 28.6%) and with smaller processed blood volume (2.2 vs 3 x total blood volume).Per the article, "donors were evaluated after receiving g-csf for hpc mobilization.The symptoms were graded as: mild¿no medication needed, moderate¿pain responded to medication (nonsteroid anti-inflammatory drugs [nsaids] or oxycodone), and severe¿when pain did not respond to medication (nsaid or oxycodone)." donors characteristics: n (%) (total n = 18) sex: male 12 (66.7%) female 6 (33.3%) age (years) median = 38 (range: 21-58) bmi median = 29 (range: 20.9-38.1) race white 10 (55.6%) black 2 (11.1%) hispanic 6 (33.3%) processed volume median = 2.6 (range: 1.5-5.9) (fold of tbv) baseline probnp median = 24 (range: 5-64) (pg/ml) (n = 15) post-g-csf symptoms severe 3 (16.7%) moderate 2 (11.1%) mild 13 (72.2%) of the 18 donors, the index donor that resulted in the initiation of the study was a healthy donor, 41 years old, female.During the apheresis procedure, she complained of intractable headache, photophobia and nausea; however, her vitals remained stable, with pre-procedure blood pressures of 113/74 mmhg vs post-procedure 113/76 mmhg.She was counseled and discharged with a dose of oxycodone (5 mg).However, her symptoms worsened and she presented to the emergency department (ed) 5 h after completion of her donation.She reported ¿the worst headache in my life¿ at the ed, and she also appeared to be dyspneic.Her blood pressure at ed was elevated to 131/78 mmhg, heart rate was 90 beats per minute.Head ct was negative for hemorrhage or mass effect.Laboratory findings included several signs associated with gcsf mobilization and apheresis, such as leukocytosis, decreased platelets, increased alkaline phosphatase (257 u/l [reference range 35-105 u/l]) and transaminases (ast 53 u/l) (range < 31 u/l) and alt 50 u/l (range < 33 u/l), in addition to markedly elevated serum probnp at 483 pg/ml (normal <125 pg/ml for <75 yearold), despite no other clinical evidence of cardiac insufficiency or pulmonary abnormalities.Her chest x-ray and echocardiogram were within normal limits.Her other laboratory results showed normal kidney function (bun/creatinine ratio of 9, normal 5-20), troponin t < 0.01 ng/ml.Treatment for symptoms is not specified in the article.Further details regarding patient information or recovery from events is not provided in the article, therefore this report is being provided as a summary.The device is not available for return for evaluation.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA IDL 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: 14187975
• MDR Text Key: 289895192
• Report Number: 1722028-2022-00135
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583103108
• UDI-Public: 05020583103108
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: BK150251
• 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
• Report Date: 04/22/2022

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
• Initial Date Manufacturer Received: 03/28/2022
• Initial Date FDA Received: 04/22/2022
• Supplement Dates Manufacturer Received: 05/17/2022
• Supplement Dates FDA Received: 05/19/2022
• 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: 41 YR
• Patient Sex: Female