| Catalog Number 4121201 |
| Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
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| Patient Problem
Bacterial Infection (1735)
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| Event Date 09/01/2023 |
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Event Type
malfunction
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Manufacturer Narrative
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Lot number, manufacture and expiry date are not available at this time.Investigation: the articles conclusion is as follows: "overall, the outcomes of this study strongly support the use of off-line ecp treatment as an effective therapeutic option for adult patients with agvhd and cgvhd, providing valuable insights into the response rates and associated factors in each group.Future research can build on these findings to enhance treatment strategies and improve patient outcomes in the management of gvhd." investigation is in process, a follow-up report will be provided.Citation: cantó, p.A., sanz, j., pell-ilderton, c.S., ruiz, j.S., madrid, p.L., villalba, m., malvar, a., chorão, p., guerreiro, m., balaguer-roselló, a., gómez, j., balsera, m.S., alcaína, p.S., sanz, m.Á., de la rubia comos, j., & gómez-seguí, i.(2023).Real-world experience in extracorporeal photopheresis for adults with graft-versus-host disease.Transplantation and cellular therapy, 29(12), 765.E1-765.E8.Https://doi.Org/10.1016/j.Jtct.2023.09.001.
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Event Description
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Per journal article "real-world experience in extracorporeal photopheresisfor adults with graft-versus-host disease".Transplant cell ther #volume# (2023): #pages#" by asensi cantó, p.,sanz caballer, j.,sopeña pell-ilderton, c.,solís ruiz, j.,lloret madrid, p.,montaner villalba, m.,facal malvar, a.,chorão, p.,guerreiro, m.,balaguer roselló, a.,montoro gómez, j.,santiago balsera, m.,solves alcaína, p.,sanz alonso, m.A.,de la rubia comos, j.,gómez-seguí, i.Bacterial isolates found in the apheresis product included micrococcus luteus, klebsiella pneumoniae, and escherichia coli.Immediate antibiotics administration was initiated on detection of k.Pneumoniae and e.Coli, preventing the progression to clinical infection.Because m.Luteus was considered a contamination of cultures, no specific action was taken.All 3 cases were thoroughly investigated, and the presence of bacteremia was considered an early recognition of silent bacteremia rather than a manipulation-transmitted infection.Patient information and outcome are unknown at this time.The collection set is not available for return because it was discarded by the customer.
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Manufacturer Narrative
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This report is being filed to provide additional information in h.6 and h.11.Investigation: the articles conclusion is as follows: "overall, the outcomes of this study strongly support the use of off-line ecp treatment as an effective therapeutic option for adult patients with agvhd and cgvhd, providing valuable insights into the response rates and associated factors in each group.Future research can build on these findings to enhance treatment strategies and improve patient outcomes in the management of gvhd." 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.The authors attributed silent bacteremia as the root cause of the microbial contamination in all three products.There is no evidence to indicate that the spectra optia device caused or contributed to the microbial contamination.Therefore, there is no failure mode or associated risk that can be evaluated for spectra optia.A request for lot numbers is not feasible because there are many months between collection of data, to peer review, to final publication.Therefore, a dhr search could not be conducted for this specific incident.All lots must meet acceptance criteria for release.This study shows the feasibility, safety, and efficacy of off- line ecp treatment in adult patients with agvhd and cgvhd, performed on 1 day and processing 1 total blood volume.The results indicate a significantly high response rate in both agvhd patients (61%) and cgvhd patients (87%).Notably, the vast majority of the responders in the agvhd group achieved cr (94.4%), whereas in the cgvhd group, there was a more balanced distribution with 45% achieving a cr and 55% achieving a pr.On multivariate analysis, the severity of agvhd emerged as the sole factor associated with response in patients with agvhd.On the other hand, among patients with cgvhd, oral involvement and lymphocyte count were identified as fac- tors associated with treatment response.These findings under- score the importance of considering specific factors that influence treatment response in both agvhd and cgvhd.In terms of safety and feasibility, several differences emerged in the comparison with our pediatric series, who received homogeneous treatment in the same institution.In adults, the proportions of suspended and complicated sessions, as well as catheter-related infections, were substantially reduced.Adults had lower use of central access, leading us to think that catheter infections in patients receiving ecp are more likely related to the presence of a central catheter itself rather than to ecp-induced immunosuppression.The absence of an increase in infectious risk favors ecp over other available alternatives in the second-line treatment of gvhd [25].After the analysis of both series, we conclude that the safety and feasibility profile of ecp, already acceptable in children, is considerably better in adults.The phenomenon of bacterial contamination in blood products, especially platelets, is known to occur.With current technologies, given the nature of microorganisms on human skin and the mechanical act of piercing the skin coupled with the fact that platelets must be incubated at room temperature it is not possible to eliminate this phenomenon from occurring.The devices terumo bct manufactures in lakewood / littleton, co, vietnam, costa rica and harmac to collect, separate and store blood products are terminally sterilized to an sal of < 1.0 x 10-6.Additionally, a sterility assurance system has been designed and employed to ensure this sal will be achieved for every product manufactured.Therefore, it may be concluded bacterial contamination observed in collected blood products from terumo bct devices is most likely due to the inherit hazard of collecting blood as it relates to bacterial contamination.Root cause: a root cause assessment was performed for the reported low flow in venous catheter.The authors stated that ¿sessions affected by venous access or apheresis device issues were performed at a slower flow rate and were ultimately completed.¿ a root cause assessment was performed for the reported hypocalcemia.The authors stated that ¿hypocalcemia symptoms were resolved in all cases through oral calcium supplementation.¿ 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 or underlying 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 ac infusion rate.A root cause assessment was performed for the reported bacterial contamination of the apheresis products.The authors stated that ¿bacterial isolates found in the apheresis product included micrococcus luteus, klebsiella pneumoniae, and escherichia coli.Immediate antibiotics administration was initiated on detection of k.Pneumoniae and e.Coli, preventing the progression to clinical infection.Because m.Luteus was considered a contamination of cultures, no specific action was taken.All 3 cases were thoroughly investigated, and the presence of bacteremia was considered an early recognition of silent bacteremia rather than a manipulation-transmitted infection.¿ a root cause assessment was performed for the reported thrombus in the apheresis tubing.Based on the available information a definitive root cause could not be determined but it is likely due to one or a combination of the possible causes listed below: the inlet/anti-coagulant ratios used in the procedure were inadequate to keep the extracorporeal circuit properly anti-coagulated, resulting in the activation of platelets.Activation of platelets as a result of the patient's physiology.When a dual-lumen catheter is used during calcium supplementation, there is some risk of recirculation.Calcium infused at the return site could be pumped into the extracorporeal circuit rather than to the patient.This could reverse some of the effect of the citrate anticoagulation and cause clumping in the circuit.Pausing the procedure but not the calcium infusion could cause clumping in the return line and potentially the circuit.Giving a bolus of calcium rather than a continuous infusion could also increase the likelihood of clumping in the circuit.Excessive calcium infusion in combination with a higher inlet:ac ratio could lead to clotting in the circuit.A root cause assessment was performed for the reported system leaks.Based on the available information a definitive root cause could not be determined but it is likely due to one or a combination of the possible causes listed below: a defective disposable set an operator error where the disposable set was misloaded a root cause assessment was performed for the reported unsolved system alarm.Based on the available information a definitive root cause could not be determined but it is likely due to one or a combination of the possible causes listed below: a defective disposable set an equipment malfunction, inaccurate entry of patient¿s parameters, alarms as a result of patient¿s physiology or underlying disease state citation: cantó, p.A., sanz, j., pell-ilderton, c.S., ruiz, j.S., madrid, p.L., villalba, m., malvar, a., chorão, p., guerreiro, m., balaguer-roselló, a., gómez, j., balsera, m.S., alcaína, p.S., sanz, m.Á., de la rubia comos, j., & gómez-seguí, i.(2023).Real-world experience in extracorporeal photopheresis for adults with graft-versus-host disease.Transplantation and cellular therapy, 29(12), 765.E1-765.E8.Https://doi.Org/10.1016/j.Jtct.2023.09.001.
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Event Description
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Per journal article "real-world experience in extracorporeal photopheresis for adults with graft-versus-host disease".Transplant cell ther #volume# (2023): #pages#" by asensi cantó, p.,sanz caballer, j.,sopeña pell-ilderton, c.,solís ruiz, j.,lloret madrid, p.,montaner villalba, m.,facal malvar, a.,chorão, p.,guerreiro, m.,balaguer roselló, a.,montoro gómez, j.,santiago balsera, m.,solves alcaína, p.,sanz alonso, m.A.,de la rubia comos, j.,gómez-seguí, i.Bacterial isolates found in the apheresis product included micrococcus luteus, klebsiella pneumoniae, and escherichia coli.Immediate antibiotics administration was initiated on detection of k.Pneumoniae and e.Coli, preventing the progression to clinical infection.Because m.Luteus was considered a contamination of cultures, no specific action was taken.All 3 cases were thoroughly investigated, and the presence of bacteremia was considered an early recognition of silent bacteremia rather than a manipulation-transmitted infection.A request for specific patient information is not feasible because there are many months between collection of data, to peer review, to final publication.The collection set is not available for return because it was discarded by the customer.
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Search Alerts/Recalls
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