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 Numbness (2415); No Clinical Signs, Symptoms or Conditions (4582)

Event Date 01/01/2020

Event Type  malfunction  

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 donors 20 years macedonian experience, reported adverse effects of apheresis procedure were bone pain as reaction of g-csf and numbness of the extremities as reaction of acd-a hypocalcemia.The abstract did not provide specific patient details, including patient information, outcome, or if any medical intervention was required, 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 b.5, e.1, g.2, h.6, and h.10.Corrected information is provided in h.1 and h.10.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.The reactions were reported as mild and no medical intervention was required.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.Root cause: a definitive root cause for the patient's reaction could not be determined.Possible causes for the alleged citrate reaction include but are not limited to ac management during the procedure, the length of the procedure and/or patient sensitivity to anticoagulant corrected investigation: the statement "according to aabb technical manual 16th edition, adverse events seen at the time of donation or those reported later average about 3.5% of donations.Reactions that need medical care after the donor has left the donation site are seen in 1 in 3400 donors." provided in follow up 1 is no longer applicable to this investigation.

Event Description

The author declined to provide any further event or patient information.

Manufacturer Narrative

This report is being filed to provide additional information in e1, h6 & 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." according to aabb technical manual 16th edition, adverse events seen at the time of donation or those reported later average about 3.5% of donations.Reactions that need medical care after the donor has left the donation site are seen in 1 in 3400 donors.The customer did not provide the lot number pertaining to this event, therefore a device history record (dhr) search could not be conducted for this specific incident.All lots must meet acceptance criteria before release.Since the lot number was not provided, a disposable lot history search could not be performed.Investigation is in process.A follow up report will be provided.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA IDL SET
• Manufacturer (Section D): TERUMO BCT; lakewood CO 80215
• MDR Report Key: 11436563
• MDR Text Key: 247073111
• Report Number: 1722028-2021-00100
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583103108
• UDI-Public: 05020583103108
• Combination Product (y/n): N
• PMA/PMN Number: BK150251
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: foreign,health 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: 10310
• Device Catalogue Number: 10310
• Was Device Available for Evaluation?: No
• Was the Report Sent to FDA?: Yes
• Date Manufacturer Received: 05/10/2021
• Is This a Reprocessed and Reused Single-Use Device?: No
• Patient Sequence Number: 1
• Patient Outcome(s): Other