MAUDE Adverse Event Report: TERUMO BCT COBE SPECTRA; WBC SET, FUNCT. CLOSED, ISBT

Model Number 70620

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

Patient Problem Numbness (2415)

Event Date 01/01/2020

Event Type  Injury  

Manufacturer Narrative

Lot number and expiry information are not available at this time.Article citation: grubovikj rastvorceva, r., useini, s., petkovikj, e., georgievski, b., panovska-stavridis, i., pivkova- veljanovska, a., hristova-dimceva, a., genadieva-stavric, s., cevreska, l., stojanoski, z., chadievski, l., grubovic, m.Apheresis collection of mobilized peripheral blood stem cells in healty donors-20 years macedonian experience.Vox sanguinis.2020.115:372 investigation is in process.A follow-up report will be provided.

Event Description

In the abstract, apheresis collection of mobilized peripheral blood stem cells in healthy donor 20 years macedonian experience, the reported adverse effects of the apheresis procedure were bone pain as reaction of g-csf and numbness of the extremities as reaction of acd-a (hypocalcemia), which occur rarely and were very mild.The abstract did not provide specific patient details, including patient information, outcome, or if any medical intervention was requried, therefore, this report is being filed as a summary of the events and patients.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 h10.Investigation: per the article, methods used were: "this is a retrospective study performed in the institute for transfusion medicine of republic of north macedonia and university hematology hospital for period from 2000 till 2020.All donors were hla typed and matched; they were fully informed on the donation procedure and signed an informed consent for donation.Minimum dose required to ensure successful and sustained engraftment was 2x106/kg cd34+ cells and 2x108/kg mono-nucleated cells (mnc).Pbsc harvesting was performed with continuous flow cell separator baxter cs3000, cobe spectra and terumo bct spectra optia using conventional-volume apheresis processing the 2 - 2.5 total blood volumes per apheresis.A femoral catheter was used for harvesting and acid citrate dextrose formula a is used for anticoagulation.Recombinant human granulocyte colony-stimulating factor (g-csf) is used to mobilize pbpc for collection.Harvesting of pbsc is usually performed after 4 to 5 days of g-csf subcutaneous administration at a dose of 10 ¿g/kg body weight." results of the study were: "most of the donors were siblings of the patients treated at the university hematology hospital, 111 donors and 2 unrelated voluntary donors who donated through bmdw.There were 172 apheresis procedures performed in 113 donors.There were 71 male and 41 females, aged 16-63.One to two apheresis procedures were required to collect adequate graft.The single procedure usually took 3-4,5 hours and the volume of collected stem cells was 50-400 ml.The needed number of mnc and cd34+ cells was successfully collected with 1,5 apheresis.There were 43 abo incompatible donors." investigation is in process.A follow up report will be provided.

Manufacturer Narrative

Investigation: according to therapeutic apheresis: a physician's handbook, adverse events occur during therapeutic procedures with a frequency of 4.8%.Some of the most common reactions include fever, urticaria, hypocalcemic symptoms, pruritus, dyspnea, tachycardia, and mild hypotension.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 since this retrospective study was to present 20 years of experience with apheresis collecting of peripheral blood stem cells (pbsc) in donors for period from 2000 till 2020, the lot numbers were not provided; therefore, a dhr search could not be conducted for this specific 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.

Event Description

This retrospective study was to present 20 years of experience with apheresis collecting of peripheral blood stem cells (pbsc) in donors for period from 2000 till 2020.A request for specific patient information is not feasible.There were 71 male and 41 females, aged 16-63.

• Brand Name: COBE SPECTRA
• Type of Device: WBC SET, FUNCT. CLOSED, ISBT
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• Manufacturer Contact: scot hilden ; 10810 w. collins ave; lakewood, CO 80215 ; 3032314970
• MDR Report Key: 11436648
• MDR Text Key: 243103731
• Report Number: 1722028-2021-00101
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583706200
• UDI-Public: 05020583706200
• Combination Product (y/n): N
• Reporter Country Code: MK
• PMA/PMN Number: BK080035
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup,Followup
• Report Date: 03/08/2021

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 03/08/2021
• Is this an Adverse Event Report?: Yes
• Is this a Product Problem Report?: No
• Device Operator: Health Professional
• Device Model Number: 70620
• Device Catalogue Number: 70620
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 05/16/2022
• Was Device Evaluated by Manufacturer?: Device Not Returned to Manufacturer
• 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