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

Model Number 10220

Device Problem Insufficient Information (3190)

Patient Problems Fever (1858); Low Blood Pressure/ Hypotension (1914)

Event Date 12/31/2019

Event Type  Injury  

Manufacturer Narrative

Lot number, manufacture and expiry are not available at this time.Investigation is in process.A follow up report will be provided.Article citation: sebastián, e., et.Al.Extracorporeal photopheresis in paediatric patients: a retrospective comparison between different 'off-line' protocols.Vox sang.2022.

Event Description

The journal article, extracorporeal photopheresis in paediatric patients: a retrospective comparison between different 'off-line' protocols' discusses a retrospective study of 91 patients diagnosed with acute or chronic graft vs host disease (gvhd) were included from september 2006 to november 2019 who underwent 1524 apheresis procedures with either the cobe spectra or spectra optia system.The most frequent collection-related adverse events concerned venous access in 329 (21.7%).Most procedures (930 of them, which represents 61%) were performed using a catheter placed in the femoral vein followed by the jugular (19.9%); only 8.1% of procedures were performed through peripheral veins.The catheter-related adverse events recorded were as follows: need to change return/access line in 214 of 329 procedures (65%); catheter flushing in 165 procedures (50.5%); use of urokinase anticoagulation to achieve the adequate flow rate in 104 (31.6%); infection in 48 (14.5%); and haematoma or pain in 10 (3%).Only one patient developed severe hypotension and fever (most likely secondary to infection).Additionally, citrate toxicity was recorded in 6.2% of all procedures, causing episodes of paraesthesia, nausea or vomiting related to mild hypocalcaemia.Median levels of haematocrit and platelet loss were 2.9% (0.7¿4.7) and 28.6% (15.7¿39.2), respectively.Transfusion support consisted of packed red blood in 20.1% of collections and platelet support in 11.8%.However, it is important to mention that most procedures were well-tolerated, and only one required interruption due to an adverse event (severe hypotension and fever as mentioned above).Exact patient details are not provided, therefore this report is being provided as a summary of events.Details are not provided regarding what, if any, medical intervention was required for any of the events.The sets are not available for return for evaluation.

Event Description

The journal article, extracorporeal photopheresis in paediatric patients: a retrospective comparison between different 'off-line' protocols' discusses a retrospective study of 91 patients diagnosed with acute or chronic graft vs host disease (gvhd) were included from september 2006 to november 2019 who underwent 1524 apheresis procedures with either the cobe spectra or spectra optia system.The most frequent collection-related adverse events concerned venous access in 329 (21.7%).Most procedures (930 of them, which represents 61%) were performed using a catheter placed in the femoral vein followed by the jugular (19.9%); only 8.1% of procedures were performed through peripheral veins.The catheter-related adverse events recorded were as follows: need to change return/access line in 214 of 329 procedures (65%); catheter flushing in 165 procedures (50.5%); use of urokinase anticoagulation to achieve the adequate flow rate in 104 (31.6%); infection in 48 (14.5%); and haematoma or pain in 10 (3%).Only one patient developed severe hypotension and fever (most likely secondary to infection).Additionally, citrate toxicity was recorded in 6.2% of all procedures, causing episodes of paraesthesia, nausea or vomiting related to mild hypocalcaemia.Median levels of haematocrit and platelet loss were 2.9% (0.7¿4.7) and 28.6% (15.7¿39.2), respectively.Transfusion support consisted of packed red blood in 20.1% of collections and platelet support in 11.8%.However, it is important to mention that most procedures were well-tolerated, and only one required interruption due to an adverse event (severe hypotension and fever as mentioned above).Exact patient details are not provided, therefore this report is being provided as a summary of events.Details are not provided regarding what, if any, medical intervention was required for any of the events.Patient information was not available.This was a journal publication to assess the role of extracorporeal photopheresis in the management of children with graft-vs-host disease on 33 patients between october 2013 and december 2021.A request for specific patient information is not feasible.The sets are not available for return for evaluation.

Manufacturer Narrative

This report is being filed to provide additional information in h.6 and h.11.Investigation: since this was a journal publication to assess the role of extracorporeal photopheresis in the management of children with graft-vs-host disease on 33 patients between october 2013 and december 2021, 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.Since this was a journal publication to assess the role of extracorporeal photopheresis in the management of children with graft-vs-host disease on 33 patients between october 2013 and december 2021, the lot numbers were not requested; therefore, a disposable lot history search could not be conducted.The authors explained mncs were collected and processed with an in-line system (cellextherakos.Mallinckrodt pharmaceuticals, bedminster, new jersey) from 2013 to 2014, and with an off-line system from 2015 onwards, using spectra optia (terumo bct, lakewood, colorado) for cell collection and macogenic g2 (macopharma, mouveaux, france) or uva-pit system (medtech solutions illuminator, cadolzburg, germany) for the illumination process.The transition from an in-line to an off-line system was due to providers' issues and it was not motivated by any technical consideration.Per protocol, blood volume processed per session was 1500 ml with the in-line system or one total blood volume (tbv) in children weighing <25 kg.With the off-line system, one tbv was processed per protocol, although children weighing <25 kg were processed 1.2-1.5 tbv.Anticoagulant citrate dextrose solution (acd-a) was perfused at a whole blood:acd-a ratio of 15:1.Patients weighing under 25 kg received prophylactic intravenous calcium and the system was primed with a concentrate of ab0-compatible, irradiated red blood cells.Red blood cell concentrates were diluted with the addition of 100-200 ml of saline solution in sterile conditions to achieve a hematocrit level similar to that of the patient.Cell collection efficiency was calculated with the ce2 formula, as follows: ce = (mnc)product * volumeproduct / (mnc)pre * (volumeprocessed ¿ volumeanticoagulant) a total of 710 sessions were initially planned.Of those, 9 could not be started due to inadequate vein access (n = 3), preprocedural anemia (n = 3), deteriorated clinical state (n = 2), and lymphopenia (n = 1).Among the remaining 701 sessions, 682 (97%) could be completely executed.The reasons that precluded ecp completion in 19 sessions were catheter dysfunction (n = 12), collection equipment errors (n = 5), and hypocalcemia and lipemic plasma (n = 1, each).Catheter dysfunction was attributed to catheter breakage and blood leaks (n = 3) and thrombosis (n = 2).In the remaining cases (n = 7) the cause was not identified.Issues that hindered ecp but did not impede its conclusion were: low flow (n = 46), postprocedural anemia (n = 3), pericatheter hematoma (n = 2), headache (n = 2), and hypocalcemia, abdominal pain, and tachypnea (n = 1, each).All these adverse effects were considered mild and were corrected spontaneously or with medical management in the apheresis unit.Additionally to the complications detected during ecp sessions, six catheter-related infections and two catheter thrombosis were detected during follow-up.In the interval between ecp sessions, one patient developed a lethal septic shock caused by a pseudomonas aeruginosa that was also isolated in the catheter.Ecp was the only reason to maintain a central line in all these patients.Four patients developed iron deficiency during ecp treatment, despite red blood cell priming in three of them.Six central catheters had to be substituted due to low flow during ecp (n = 2), catheter-related infections (n = 2), thrombosis (n = 1), and breakage (n = 1).Four catheters had to be replaced after accidental dislodgement.Table 3 lists causes of ecp interruption and complications as well as other adverse effects attributable to ecp.Overall, authors concluded ecp is feasible, safe and effective for pediatric patients with corticorefractory or corticodependant gvhd, offering a less toxic and nonimmunosuppressive treatment option.Per internal sterilization documents the disposable devices manufactured by terumo bct vietnam, costa rica, lakewood / littleton, co and harmac must have a final sterility assurance level (sal) of < 1.0 x 10-6.This means that following terminal sterilization one or fewer products out of 1 million products sterilized could potentially have a surviving organism.To ensure that this level of sterility is met or exceeded, terumo bct employs a sterility assurance system throughout the entire manufacturing process.The attributes of this sterility assurance system are listed below as well as how each contributes to ensuring the product meets or exceeds the required sal of < 1.0 x 10-6.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 parasethesia (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.The small amount of red cells lost in the apheresis circuit may be more apparent in an anemic patient who has meager production capacity and who is receiving multiple procedures.Although generally well tolerated, the large-volume leukocytapheresis for stem cell collections in patients often results in a decline in hematocrit and platelet count, particularly because some red cells and platelets are incidentally removed with the stem cells.Adverse effects related to vascular access are a frequent concern.Hematoma, venous sclerosis and thrombosis can complicate percutaneous needle puncture.Hemorrhage or pneumothorax or both may complicate cvc insertion, while thrombosis and infection are the most frequently observed complications of prolonged central venous access.Blocked cvcs can sometimes be cleared with a fibrinolytic agent such as tpa.Root cause: based on the available information within the journal article, a definitive root cause could not be determined for the reported adverse events.The journal mentioned allegations of hypocalcemia, anemia, infections and thrombosis related to the apheresis procedures.Hypocalcemia may occur due to decreased ionized calcium in circulation as a result of exogenous citrate administered during the apheresis procedure and are influenced by donor physiology, 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 ac infusion rate.Possible causes for iron deficiency include are not limited to: * patient's underlying disease state * patient's blood physiology interferes with separation of cellular components and chamber triggering (i.E.Abnormal rbcs, hyperviscous plasma) * incorrect setting of collection preference * the presence of a small buffy coat which resulted in red cells getting collected along with the target cells * inaccurate entry of the patient's hematocrit * inlet flow rate was too high to adequately separate red cells from buffy coat * rbc port height is too high * improper loading of the channel into the filler * hazy camera window which causes the light to diffuse around the collect port.This makes the collect port appear light, even when rbcs are flowing through the port * lighting is too bright due to improperly calibrated diffuser plate a definitive root cause for the infections could not be determined.Sources of bacterial contamination include but are not limited to patient connection to the disposable set (i.E.Prolonged cvl access) and/or post-processing laboratory practices such as qc sampling or handling techniques.Cause for the alleged thrombosis is undetermined but may be due to the patient¿s underlying condition and/or placement of the catheter.Several non-adverse events related to terumo bct product/performance related issues were documented.Lipemic plasma is most likely related to the patient¿s physiology.Headache, abdominal pain and polypnea could be related to patient sensitivity to the apheresis procedure.Possible causes for the hematomas include but are not limited to: *poor phlebotomy technique causing the needle to unintentionally enter the tissue surrounding the blood vessel *dislodgement of the needle from the vein due to arm movement, a poorly secured needle, or an inadequate choice of venous site to puncture *an excessively high return flow rate flow/access issues could be related to: *patient access was not properly positioned *inlet line or single-needle connector was obstructed due to kinks, clamps, or clumping *inlet pump flow rate was too high for the size of the patient access the documented patient death which occurred during the interval between ecp is not related to the use of the terumo bct device and/or apheresis procedure.Article citation: sebastián, e., et.Al.Extracorporeal photopheresis in paediatric patients: a retrospective comparison between different 'off-line' protocols.Vox sang.2022.

• Brand Name: SPECTRA OPTIA
• Type of Device: SPECTRA OPTIA EXCHANGE 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: 15640242
• MDR Text Key: 302094664
• Report Number: 1722028-2022-00345
• Device Sequence Number: 1
• Product Code: GKT
• UDI-Device Identifier: 05020583102200
• UDI-Public: 05020583102200
• Combination Product (y/n): N
• Reporter Country Code: SP
• PMA/PMN Number: BK150251
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: Foreign,Literature,Health Professional
• Reporter Occupation: Other Health Care Professional
• Type of Report: Initial
• Report Date: 10/20/2022

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: 10220
• Device Catalogue Number: 10220
• Was Device Available for Evaluation?: No
• Is the Reporter a Health Professional?: Yes
• Initial Date Manufacturer Received: 09/26/2022
• Initial Date FDA Received: 10/20/2022
• 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