MAUDE Adverse Event Report: TERUMO BCT COBE SPECTRA; COBE SPECTRA AUTOPBSC SET, ISBT

Model Number	70610
Health Effect - Clinical Code	Reaction (2414)
Date of Event	01/01/2012
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Lot number and expiry information are not available at this time.Citation: baricevic, marijana."ucestalost ne¿eljenih reakcija tijekom prikupljanja krvotvornih maticnih stanica iz periferne krvi." clinical institute for transfusion medicine and transplantation biology of the clinical hospital center.Investigation is in process.A follow-up report will be provided.
Event or Problem Description
Per the article, 'the presence of unwanted reactions by the purchase of hematopoietic stem stations from peripheral blood', 1804 autologous apheresis procedures in 909 patients and 184 allogenic apheresis procedures in 104 healthy donors were assessed.This journal analyzed 1804 autologous apheresis procedures performed in 909 patients (54,2% males, 45,8% females) who were mobilized using chemotherapy and/or hematopoietic growth factors.Also, they analyzed 184 allogenic apheresis procedures performed in 104 health donors (48% males, 52% females).The leukapheresis procedures were performed with cell separator cobe spectra.Most of the patients required a double-lumen central vein catheter (99,8%).Most of the leukapheresis procedures performed in healthy donors required peripheral vein access (88,5%).During all procedures calcium was administered preventively.Per the article, adverse reactions were observed during 16 procedures (6.8%) in pediatric patients and during 119 procedures (7.6%) in adult patients.Healthy adult donors experienced adverse reactions during 9 procedures (5.5%), while no reaction occurred in pediatric healthy donors.The citrate induced reactions were most commonly observed.The reactions were mostly mild, and cessation of collection was required in only 1.3% cases in patients donations and in 1.6% healthy donor donations.Summary of adverse reactions: 138 citrate reactions in adults and pediatrics with unknown medical intervention 21 vasovagal reactions in adults and pediatrics with unknown medical intervention 7 unspecified pains in adults and pediatrics with unknown medical intervention 1 chill in adult with unknown medical intervention 2 periorbital swelling of face in pediatric with unknown medical intervention 1 petechiae--tiny purple, red, or brown spots on the skin in adult with unknown medical intervention 10 citrate reactions in adults with unknown medical intervention 1 vasovagal reaction in adult with unknown medical intervention 1 pain in the hand for an adult patient with unknown medical intervention 1 pain behind the sternum for an adult patient with unknown medical intervention the disposable set is not available for return because it was discarded by the customer.
Event or Problem Description
This was a retrospective clinical study to evaluate the incidence of adverse reactions during collection of peripheral blood hematopoietic progenitor cells in 1804 autologous apheresis procedures performed in 909 patients (54,2% males, 45,8% females) who were mobilized using chemotherapy and/or hematopoietic growth factors.Also, they analyzed 184 allogenic apheresis procedures performed in 104 health donors (48% males, 52% females).Attainment of individual patient details is not feasible.
Additional Manufacturer Narrative
This report is being filed to provide additional information in b.5, e.1, e.3,and h.10.Investigation: 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 paresthesia (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.Vasovagal incidents occur around 0.5% of procedures.The reactions generally manifest as pallor and diaphoresis.In a full blown attack, the reaction progresses from pallor and sweating to pulse slowing and blood pressure decreasing.More severe vasovagal reactions may include nausea, vomiting, and/or convulsions.Symptoms of these allergic reactions may include hives, dyspnea, wheezing, burning eyes, tachycardia, hypotension, and or facial swelling and flushing.Mild reactions can be treated with diphenhydramine administered through an iv.The disposable sets were not available for return.Since this was a retrospective clinical study to evaluate the incidence of adverse reactions during collection of peripheral blood hematopoietic progenitor cells in 1804 autologous apheresis procedures and 184 allogenic apheresis procedures, the lot numbers are unknown.Dhr details: 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.Root cause: a specific root cause for the reported citrate reactions could not be determined.These reactions occur due to decreased ionized calcium in circulation as a result of exogenous citrate administered during the apheresis procedure and are influenced by patient physiology, the patient's disease state, the rate of ac infusion, and/or the length of the procedure.These symptoms may be treated with oral or intravenous calcium supplements or by adjusting the acd infusion.Possible causes for the alleged vasovagal reaction include but are not limited to patient disease state and/or patient sensitivity to the procedure.A definitive root cause of the allergic reactions could not be determined.Possible causes include but are not limited to: - patient sensitivity to the replacement fluids - patient sensitivity to the ethylene oxide used to sterilize the disposable set.

• Brand Name: COBE SPECTRA
• Common Device Name: COBE SPECTRA AUTOPBSC SET, ISBT
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: scot hilden ; 10810 w. collins ave; lakewood, CO 80215 ; 3032314970
• MDR Report Key: 9996285
• Report Number: 1722028-2020-00184
• Device Sequence Number: 11681587
• Product Code: GKT
• UDI-Device Identifier: 05020583706101
• UDI-Public: 05020583706101
• Combination Product (Y/N): N
• Initial Reporter Country: HR
• PMA/510(K) Number: BK080035
• Number of Events Summarized: 1
• Summary Report (Y/N): N
• Serviced by Third Party (Y/N): Unknown
• Reporter Type: Manufacturer
• Report Source: Foreign,Literature,Health Professional
• Initial Reporter Occupation: Nurse
• Type of Report: Initial,Followup
• Report Date (Section B): 04/24/2020

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
• Operator of Device: Health Professional
• Device Model Number: 70610
• Device Catalogue Number: 70610
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 04/01/2020
• Supplement Date Received by Manufacturer: 06/30/2022
• Initial Report FDA Received Date: 04/24/2020
• Supplement Report FDA Received Date: 07/08/2022
• Was Device Evaluated by Manufacturer? (Y/N): Device Not Returned to Manufacturer
• Is the Device Labeled for Single Use? (Y/N): Yes
• Is This a Single-Use Device that was Reprocessed and Reused on a Patient? (Y/N): No
• Usage of Device: Initial
• Patient Sequence Number: 1
• Outcome Attributed to Adverse Event: Other
• Patient Sex: Unknown