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

Catalog Number	70610
Medical Device Problem Codes	Adverse Event Without Identified Device or Use Problem (2993); Insufficient Device Problem Information (3190)
Health Effect - Clinical Codes	Bradycardia (1751); Fever (1858); Low Blood Pressure/ Hypotension (1914); Pulmonary Edema (2020); Vomiting (2144); Bronchospasm (2598)
Date of Event	10/07/2020
Type of Reportable Event	Serious Injury
Additional Manufacturer Narrative
Lot number, manufacture and expiry date are not available at this time.Investigation is in process, a follow-up report will be provided.Devasia, a.J., abraham, m.A., sagadevan, c., korula, a., kulkarni, u., fouzia, n., abraham, a., srivastava, a., mathews, v., george, s.P., & george, b.(2021).Safety of peripheral blood stem cell harvest in children under anaesthesia in the day care setting a single centre experience.Transfusion and apheresis science, 60(1), 102962.Https://doi.Org/10.1016/j.Transci.2020.102962.
Event or Problem Description
Per journal article "safety of peripheral blood stem cell harvest in children under anaesthesia in the day care setting a single centre experience" by devasia, a.J., abraham, m.A., sagadevan, c., korula, a., kulkarni, u., fouzia, n.A., abraham, a., srivastava, a., mathews, v., george, s.P., george, b.Potential adverse event : bone and generalized body pain was reported by 35 (22.7%) children when they received g-csf for stem cell mobilization.These donors were given oral analgesics and they completely responded.Pain was not reported after g-csf priming was over.During insertion of the access line, one donor developed a local hematoma in the femoral region, while in another donor, the guide wire was not easily negotiated.No donor developed symptoms related to hypocalcaemia during the infusion.The vital signs were monitored with non-invasive devices.Seven donors developed transient hypotension requiring fluid boluses and intermittent doses of ephedrine in 6 donors and phenylephrine in 1 donor.One donor had transient bradycardia which was managed successfully with bronchodilators.Recovery from sedation was smooth and all donors were fully awake at a median of 20 (560) minutes from the time of harvest.In donors in whom lma was inserted, the median time to wake up was found to be 10 min longer than the other groups.One donor needed to be shifted to the intensive care unit for monitoring for a short period of 8 h as he developed acute pulmonary edema secondary to infusion of blood products.None of the donors required intubation during the procedure.Following the procedure fever and vomiting was seen in one donor each.Vascular access channels were removed on the same day of the harvest, except in cases where it had to be preserved for a repeat harvest on the next day.All donors were discharged on the next day of harvest.No long term complications have so far been reported in any of these donors.Specific details, such as patient information and outcome, were not included in the article for these events, therefore this report is being provided as a summary of the events.The collection set is not available for return because it was discarded by the customer.
Additional Manufacturer Narrative
This report is being filed to provide additional information in b.5, h.6 and h.11 and corrections in d.2a, d2.B and d.4.Investigation: summary of terumo bct product in relation to the journal article: stem cell harvest: stem cell harvest was done with a continuous flow blood cell separator (cobe spectra pbsc).The psbc apheresis kit cobe spectra apheresis system is loaded on to the apheresis machine.The weight, height, hematocrit and gender of the donor is entered into the pbsc system.Based on this the total blood volume of the donor is estimated as 80 ml/kg.Volume equivalent to 3 times the estimated blood volume of the donor is processed for the harvest which is called the processed inlet volume.Acid citrate dextrose (acd - terumo penpol) is mixed automatically into the apheresis system at a ratio of 1 ml of acd to every 12 ml of blood volume.The amount of blood to be processed per minute is estimated by the apheresis system based on the donor blood and acd volume and is called the blood flow rate.The extra corporeal line was primed with 300 ml of irradiated red blood cells that is compatible with the donor if the donor weight is less than 30 kg.The remaining packed red cells were transfused during the procedure, if the donor hemoglobin was less than 10gm% prior to the harvest.Whole blood drawn from the donor via the access line, and mixed with the anticoagulant (acd) is let into the centrifuser, where stem cells are separated based on density.These stem cells are collected into pvc collection bags (cobe).The collection rate calculated by the machine and hematopoietic progenitor cells were collected in the collection bag at the rate of 1 ml/minute.Adjustment of the interphase was optimized under visual control to a colorgram of 1 to 2 %.Autologous platelet rich plasma after separation of hematopoietic progenitor cells were returned to the donors via the return line.After collection, 1 ml of the stem cells was sent for cd34 and mononuclear cell (mnc) estimation in heparinized and edta vacutainers respectively.For cd34 enumeration in the graft, ishage gating strategy was performed as described previously.Total cell count on the harvest product was estimated by automated cell counters.Manually mnc% was estimated (proportion of uni-nucleated cells which includes lymphocytes and monocytes) and mnc cell dose was calculated from it.The harvested stem cells were stored at 4 c in the blood bank blood storage unit (for a maximum duration of up to 72 hours) till they are infused to the recipient or cryopreserved for later use.Vital signs (heart rate, blood pressure, oxygen saturation and respiration) are monitored continuously with non-invasive monitoring de vice throughout the harvest.Donors are not given oral/intravenous calcium as prophylaxis prior to the harvest procedure.Once donors are fully awake from the sedation, they are shifted to the ward and oral feeds are started after 4 hours.Donors are discharged on the next day morning.Results: between january 2009 and june 2017, a total of 152 pediatric donors and 2 patients underwent 164 pbsc harvests were done under anaesthesia in the day care at our centre.Of these, two were autologous harvests towards autologous stem cell transplants for acute promyelocytic leukemia while the rest were allogeneic harvests.The most common indication for transplant was thalassemia major (n being 110) followed by bone marrow failure syndromes (n being 23).In 10 children, a repeat harvest was done out of which, 5 underwent a repeat harvest on the next day for inadequate stem cell dose on the first day of harvest.The rest 5 were for a repeat transplant (4 for rejection of the first graft and 1 for relapse of the underlying disease 4 years later).An adequate stem cell dose was obtained with a single session of stem cell harvest in 149 (97 %) children.Complications during stem cell mobilization, harvest and recovery from anaesthesia: bone and generalized body pain was reported by 35 (22.7%) children when they received g-csf for stem cell mobilization.These donors were given oral analgesics and they completely responded.Pain was not reported after g-csf priming was over.During insertion of the access line, one donor developed a local hematoma in the femoral region, while in another donor, the guide wire was not easily negotiated.No donor developed symptoms related to hypocalcaemia during the infusion.The vital signs were monitored with non-invasive devices.Seven donors developed transient hypotension requiring fluid boluses and intermittent doses of ephedrine in 6 donors and phenylephrine in 1 donor.One donor had transient bradycardia requiring atropine.Transient bronchospasm developed in 4 donors which was managed successfully with bronchodilators.Recovery from sedation was smooth and all donors were fully awake at a median of 20 (5¿60) minutes from the time of harvest.In donors in whom lma was inserted, the median time to wake up was found to be 10 min longer than the other groups.One donor needed to be shifted to the intensive care unit for monitoring for a short period of 8 h as he developed acute pulmonary edema secondary to infusion of blood products.None of the donors required intubation during the procedure.Following the procedure fever and vomiting was seen in one donor each.Vascular access channels were removed on the same day of the harvest, except in cases where it had to be preserved for a repeat harvest on the next day.All donors were discharged on the next day of harvest.No long term complications have so far been reported in any of these donors.Overall, authors concluded the present study demonstrates that venous access placement and leukapheresis can be done under anaesthesia in small children who are unlikely to co-operate for the procedure otherwise.With due precautions, adequate expertise and proper support system, it is feasible, safe and can be performed in the day care setting in the hands of a consultant anaesthesiologist.Since this was a journal publication to assess the safety of peripheral blood stem cell harvest in children under anaesthesia in the day care setting between january 2009 to june 2017, the lot numbers were not requested; therefore, a disposable lot history search could not be conducted.Since this was a journal publication to assess the safety of peripheral blood stem cell harvest in children under anaesthesia in the day care setting between january 2009 to june 2017.A total of 158 children underwent 164 pbsc harvests during the study period.Donors were predominantly females with a median age of 5 years (1 to 12) and a median weight of 17.5 kg (9.4 to 51)., the lot numbers were not requested; therefore, a dhr search could not be conducted for this specific incident.All lots must meet acceptance criteria for release.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.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, syncope, loss of bowel and bladder control, convulsions, or a combination of these.All these phenomena have been related to imbalances in autonomic tone.The slow pulse rate is the most useful sign in differentiating vasovagal effects from hypovolemia.Attacks are best treated by maintaining the patient in a supine position with the head below the legs (trendelenburg position).The apheresis procedure should be halted until the reaction is reversed root cause: based on the available information within the journal article, acute pulmonary edema, secondary to transfusion of blood product was seen in one donor requiring a short stay in the intensive care unit (icu) for monitoring.He was shifted out of the icu on the same day and was discharged the next day.This complication could not be attributed to the procedure, and according to the authors was probably related to transfusion reaction.The reported bronchospasms are a known side effect of anaethesia and not believed to be related to the apheresis procedure.The reported bradycardia and hypotension are common side effects of therapeutic apheresis procedures, typically caused by fluid shift, blood loss, length of the procedure, donor¿s sensitivity to the procedure and/or hemodynamic stress of the procedure.Citation: devasia, a.J., abraham, m.A., sagadevan, c., korula, a., kulkarni, u., fouzia, n., abraham, a., srivastava, a., mathews, v., george, s.P., & george, b.(2021).Safety of peripheral blood stem cell harvest in children under anaesthesia in the day care setting ¿ a single centre experience.Transfusion and apheresis science, 60(1), 102962.Https://doi.Org/10.1016/j.Transci.2020.102962.
Event or Problem Description
Per journal article "safety of peripheral blood stem cell harvest in children under anaesthesia in the day care setting ¿ a single centre experience" by devasia, a.J., abraham, m.A., sagadevan, c., korula, a., kulkarni, u., fouzia, n.A., abraham, a., srivastava, a., mathews, v., george, s.P., george, b.Potential adverse event : bone and generalized body pain was reported by 35 (22.7%) children when they received g-csf for stem cell mobilization.These donors were given oral analgesics and they completely responded.Pain was not reported after g-csf priming was over.During insertion of the access line, one donor developed a local hematoma in the femoral region, while in another donor, the guide wire was not easily negotiated.No donor developed symptoms related to hypocalcaemia during the infusion.The vital signs were monitored with non-invasive devices.Seven donors developed transient hypotension requiring fluid boluses and intermittent doses of ephedrine in 6 donors and phenylephrine in 1 donor.One donor had transient bradycardia which was managed successfully with bronchodilators.Recovery from sedation was smooth and all donors were fully awake at a median of 20 (5 to 60) minutes from the time of harvest.In donors in whom lma was inserted, the median time to wake up was found to be 10 min longer than the other groups.One donor needed to be shifted to the intensive care unit for monitoring for a short period of 8 h as he developed acute pulmonary edema secondary to infusion of blood products.None of the donors required intubation during the procedure.Following the procedure fever and vomiting was seen in one donor each.Vascular access channels were removed on the same day of the harvest, except in cases where it had to be preserved for a repeat harvest on the next day.All donors were discharged on the next day of harvest.No long term complications have so far been reported in any of these donors.Specific details, such as patient information and outcome, were not included in the article for these events, therefore this report is being provided as a summary of the events.This was a journal publication to assess the safety of peripheral blood stem cell harvest in children under anaesthesia in the day care setting between january 2009 to june 2017.A total of 158 children underwent 164 pbsc harvests during the study period.Donors were predominantly females with a median age of 5 years (1 to 12) and a median weight of 17.5 kg (9.4 to 51).A request for specific donor information is not feasible.The collection set is not available for return because it was discarded by the customer.

• Brand Name: COBE SPECTRA
• Common Device Name: COBE SPECTRA AUTOPBSC SET, ISBT
• 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: 19864230
• Report Number: 1722028-2024-00311
• Device Sequence Number: 7514009
• Product Code: GKT
• UDI-Device Identifier: 05020583706101
• UDI-Public: 05020583706101
• Combination Product (Y/N): N
• Initial Reporter Country: IN
• 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
• Initial Reporter Occupation: Other Health Care Professional
• Type of Report: Initial,Followup
• Report Date (Section B): 07/30/2024

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 Catalogue Number: 70610
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Type of Report(Section G): Thirty-Day
• Initial Date Received by Manufacturer: 07/05/2024
• Supplement Date Received by Manufacturer: 01/24/2025
• Initial Report FDA Received Date: 07/30/2024
• Supplement Report FDA Received Date: 01/29/2025
• Was Device Evaluated by Manufacturer? (Y/N): No
• 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: Required Intervention; Other
• Patient Sex: Unknown