| Catalog Number 10220 |
| Device Problem
Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problem
Bacterial Infection (1735)
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| Event Date 01/26/2020 |
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Event Type
Injury
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Manufacturer Narrative
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Lot number and expiry information are not available at this time.Investigation: per the article, "although a significant number of patients experienced mild to moderate complications related mostly to hypocalcemia and allergic reactions, tpe-related mortality or severe complications are infrequent, and tpe is a relatively safe therapy." lot number and expiry information are not available at this time.Investigation: per the article, "although a significant number of patients experienced mild to moderate complications related mostly to hypocalcemia and allergic reactions, tpe-related mortality or severe complications are infrequent, and tpe is a relatively safe therapy." this was a retrospective study in a multi-institutional cohort of 109 patients with ittp between 2004 and 2017.This study included patients presenting between january 8, 2004, and april 26, 2017, with confirmed ittp at four large academic medical centers in boston.Venous access was often obtained via temporary dual-lumen apheresis catheters placed in the internal jugular or, less commonly, the femoral vein.Procedures were performed using an apheresis machine (cobe spectra or optia, terumo bct).Both standard (not virus inactivated) fresh frozen plasma and cryoprecipitate-poor plasma were used as replacement fluid, as designated by the treating physician.Anticoagulant citrate dextrose a solution was routinely infused at 1:10 inlet ratio for anticoagulation.Calcium gluconate was infused continuously throughout each procedure, and the infusion rate was increased in the setting of symptomatic hypocalcemia.Ionized calcium was not routinely measured when symptoms of hypocalcemia were reported.Most patients underwent daily, one plasma- volume exchanges.The authors had hypothesized that refractory disease, as defined by a high number of tpe treatments or long duration of hospitalization, might be associated with mortality.However, they found that neither extremes in length of hospital stay nor number of tpe procedures was predictive of mortality.The majority of deaths (5/8) were associated with delay in the diagnosis of ittp or initiation of tpe or presentation to the hospital in a moribund state.See attached article for full study details.Article citation: colling, m., et.Al.2020.Deaths and complications associated with the management of acute immune thrombotic thrombocytopenic purpura.Transfusion 2020;9999;1¿6.Investigation is in process.A follow-up report will be provided.
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Event Description
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Per the article 'deaths and complications associated with the management of acute immune thrombotic thrombocytopenic purpura' in the journal transfusion, a retrospective study was performed on 109 immune thrombotic thrombocytopenic purpura (ittp) patients between 2004 and 2017.Complications of therapeutic plasma exchange (tpe) were analyzed in a subset of the cohort.Two severe complications were included related to line- associated infections.Exact details of the complications, including patient information, exact medical intervention provided, and patient outcomes, were not provided.A summary of the complications was included in the article.This report is for the 2 line-associated reactions based on the summary provided.The disposable sets are not available for return because they were discarded by the customer.
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Manufacturer Narrative
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This report is being filed to provide additional information.Investigation: per the investigating physician, the deaths were not related to anything other than the patients' medical condition.There is no evidence to indicate that the optia device caused or contributed to the patients' death.According to therapeutic apheresis: a physician's handbook, adverse events occur during therapeutic procedures with a frequency of 4.8%.Symptoms of allergic reactions may include hives, dyspnea, wheezing, burning eyes, tachycardia, hypotension, and or facial swelling and flushing.Mild reactions can be treated with diphenhydramine administered through an iv.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.According to 'dissecting the pathophysiology of immune thrombotic thrombocytopenic purpura: interplay between genes and environmental triggers' (haematologica 2018 volume 103(2):1099-1109), thrombotic thrombocytopenic purpura (ttp) is a devastating disease resulting from a severe deficiency in the von willebrand factor (vwf)- cleaving protease adamts13.This deficiency causes the accumulation of ultra-large vwf multimers in the circulation and the formation of thrombi in the microvasculature under high shear stress conditions.When left untreated, these microthrombi cause multi-organ failure and lead to death.In the acquired immune-mediated form of, patients develop antibodies (abs) against adamts13 that enhance its clearance or inhibit its vwf processing activity.Therapeutic plasma exchange (tpe) greatly improves the fatal outcome of ittp leading to survival rates of more than 80%.Adverse effects related to vascular access are a frequent concern.Hemorrhage or pneumothorax or both may complicate cvc insertion, while thrombosis and infection are the most frequently observed complications of prolonged central venous access.During a dressing change, the site should be cleaned and observed for signs of infection such as redness, swelling, drainage, and foul odor.If an infection is suspected, cvc removal should be considered, and the patient should be treated for infection as appropriate.The cause of a cvc flow problem may sometimes be difficult to determine, although patient repositioning will sometimes improve flow.A common situation is that the cvc can be flushed without resistance but does not yield blood return; this scenario may be the result of kinking, poor positioning, intralumenal clots, or venous thrombosis.Blocked cvcs can sometimes be cleared with a fibrinolytic agent such as tpa.The placement of a cvc is considered by some to be the greatest risk related to the apheresis procedures, and it should be avoided if the procedure can be performed using peripheral iv based on literature reference, therapeutic apheresis: a physician's handbook, allergic reactions are usually associated with replacement procedures that include blood components but sensitivity to disposable tubing sterilized with ethylene oxide can also be associated with allergic reactions.Access pressure alarms may occur if the inlet line is clamped when it shouldn¿t be or if the patient/donor access is being restricted.The procedure can be continued in most circumstances once the aps pressure goes above the minimum limit.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.Investigation is in process.A follow up report will be provided.
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Manufacturer Narrative
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This report is being filed to provide additional information in investigation: according to therapeutic apheresis: a physician's handbook, adverse effects related to vascular access are a frequent concern.Hemorrhage or pneumothorax or both may complicate cvc insertion, while thrombosis and infection are the most frequently observed complications of prolonged central venous access.During a dressing change, the site should be cleaned and observed for signs of infection such as redness, swelling, drainage, and foul odor.If an infection is suspected, cvc removal should be considered, and the patient should be treated for infection as appropriate.The cause of a cvc flow problem may sometimes be difficult to determine, although patient repositioning will sometimes improve flow.A common situation is that the cvc can be flushed without resistance but does not yield blood return; this scenario may be the result of kinking, poor positioning, intralumenal clots, or venous thrombosis.Blocked cvcs can sometimes be cleared with a fibrinolytic agent such as tpa.The placement of a cvc is considered by some to be the greatest risk related to the apheresis procedures, and it should be avoided if the procedure can be performed using peripheral iv.Investigation is in process.A follow up report will be provided.
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Manufacturer Narrative
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Investigation: per internal sterility documentation, the devices terumo bct manufactures to collect, separate, and store blood products are terminally sterilized to a sterility assurance level (sal) of
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Event Description
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Since this was a retrospective study in a multi-institutional cohort of 109 patients with ittp between 2004 and 2017; a request for patient information is not feasible.Guidelines for retrospective chart reviews typically recommend that information recorded by the researcher must not identify the subject and instruct that individually identifiable data elements may not be recorded.Additionally, the researcher is not allowed to keep a linking list of any sort; it must not be possible to determine which data belong to a patient, once the data have been recorded by the researcher.
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Manufacturer Narrative
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Root cause: death associated with ittp occurred in a total of 8 of 109 patients.Of the eight (8) deaths, only four (4) of the patients underwent tpe.Based on the physician's statements in the articles, five (5) of the deaths were related to significant end-organ injury, or for whom treatment with tpe was delayed or initiation of tpe or presentation to the hospital in a moribund state.Two (2) patients died due to ittp refractory to medical therapy that included tpe and was comatose at presentation.One (1) additional patient died of line-associated bacteremia after 25 tpe procedures.Possible causes for the bacteremia include but are not limited to contamination at the time of catheter insertion, contamination during manipulation of the catheter, and/or patient susceptibility to infections.A definitive root cause for the allergic reactions could not be determined.Possible causes include but are not limited to: allergy to the replacement solution, patients' sensitivity to eto, patients' sensitivity to the disposable and/or the procedures a definitive root cause for the hypo calcemic reactions could not be determined.Possible causes include but are not limited to: ac management during the procedure and/or patient sensitivity to anticoagulant, patients' disease state a definitive root cause for the line associated complications could not be determined.Possible causes include but are not limited to: obstructed or misplaced catheter, contamination at the time of catheter insertion or during manipulation of the catheter, patients' hypercoagulable states including malignancy, sepsis, renal failure and underlying disease state.Insufficient sterilization of the access port/line a definitive root cause for the non-allergic transfusion reaction could not be determined.Possible causes include patient disease state and/or patient sensitivity to the procedure.A definitive root cause for the access pressure alarms could not be determined.Possible causes for this alarm include but are not limited to: patients' accesses were not properly positioned, inlet line or single-needle connector was obstructed due to kinks, clamps, or clumping, intralumenal clots, or venous thrombosis.Inlet pump flow rates were too high for the size of the patients' accesses, defective access pressure sensor (aps), aps out of calibration.
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Search Alerts/Recalls
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