| Catalog Number 10220 |
| Device Problems
Complete Blockage (1094); Device Displays Incorrect Message (2591); Adverse Event Without Identified Device or Use Problem (2993)
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| Patient Problem
Pulmonary Embolism (1498)
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| Event Date 12/22/2020 |
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Event Type
Injury
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Manufacturer Narrative
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Investigation : the run data file (rdf) was analyzed for this event.Review of the dlogs and images associated with this procedure did show excessive signs of clumping as the procedure progressed.The procedure started at an inlet:ac ratio of 10 throughout the entirety of the procedure.This was not adjusted even as the images started showing excessive clumping.There were several ¿inlet pressure was too low¿ and ¿return pressure was too high¿ alarms throughout the run.In addition, there were also several ¿plasma pressure was too high¿ alarms.All these could be indicative of clumping during a run.For procedures that are known to clump or have a higher probability of clumping.It may be advisable to start at a lower inlet:ac ratio and perhaps run the entire procedure at a lower ratio if it is determined that the patient has a higher probability of clumping/clotting.The likelihood for platelet clumping to occur during a run is difficult to predict since it is not dependent on a specific platelet count and varies by patient.Therefore, every procedure should be observed for platelet clumping in the connector.Clumping can affect the efficiency of the procedure by interfering with proper separation in the connector and causing excess alarms during the run.If there is excess tubing that is not anticoagulated that can also lead to clumping during the run.Preventive maintenance was completed for this device on 12/29/2020.No issues were noted; the device was verified to be operating per manufacturer specifications.Investigation is in process.A follow-up report will be provided.
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Event Description
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The customer reported that during a secondary plasma device (spd) procedure with depuro columns d2000, they could see fibrin in the extension tubing and the column pressure started to rise until they got a "high pressure" alarm and they could not resume the procedure as everything was blocked in the lines.Rinseback was not possible either because they said the whole system was coagulated.The patient had thrombosis due to the midline catheter they were using for the spd procedure and has ended up with a pulmonary embolism (pe) because the thrombus has dislodged.The patient had been given enoxaparin in prophylactic doses as part of the covid treatment.After sudden onset of dyspnea, the infectious-covid physician on duty assessed the patient and requested complementary examinations (angiotac).In addition, the enoxaparin dose was increased to anticoagulant doses.The patient was reported to be in stable condition.The disposable set is not available for return because it was discarded by the customer.Due to eu personal data protection laws, the patient identifier is not available from the customer.
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Manufacturer Narrative
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This report is being filed to provide additional information in h6 and h10 investigations: a review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.The customer did not provide the length of the extension tubing being used and did not state whether extension tubing was used on both the return and inlet lines.The customer did not provide the length of the extension tubing being used and did not state whether extension tubing was used on both the return and inlet lines.According to the optia operator's manual: 1.The default inlet:ac ratio for tpe-spd procedures is 10:1.2.In the section 'managing a positive fluid balance', the operator is informed that the total volume of the ac used during a tpe-spd procedure is returned to the patient with the treated plasma.As a result, the patient¿s fluid balance is always positive at the end of the run.The following guidelines are listed to help decrease the volume if the additional volume is an issue for the patient: ¿ increase the inlet:ac ratio to 15.0.Be aware that if the extracorporeal circuit is not adequately anticoagulated, platelet clumping could occur.For more information about anticoagulation and addressing clumps or clots in the circuit, see "managing anticoagulation of the extracorporeal circuit" on page 223.¿ do not rinse the contents remaining in the plasma device into the treated plasma bag at the end of the run.¿ do not return the contents of the treated plasma bag to the patient at the end of the run.Keep in mind that doing this leaves the patient in a plasma-negative condition.(page 113) 3.In the section, 'managing anticoagulation of the extracorporeal circuit', the operator is informed of the following: proper anticoagulation of the system's extracorporeal circuit ensures that the flow of blood and fluid through the circuit is not obstructed during the procedure.Terumo bct recommends that you use an inlet:ac ratio up to 15:1 when using acd-a.The system¿s default inlet:ac ratio depends on the procedure selected.You may need to use a different ratio, however, for a patient with a unique hematologic condition.If the circuit is not adequately anticoagulated, platelet aggregates or clots may form, and eventually cause an obstruction in one or more of the following areas: ¿ filter at the bottom of the reservoir ¿ collect port (collection set, idl set) ¿ tubing set connector, which can result in an unstable interface to eliminate the aggregates or clots, decrease the inlet:ac ratio.If an alarm occurs indicating a possible obstruction, follow the instructions on the alarm action screen, and monitor the system for the rest of the procedure.If you do not eliminate the obstruction, the system may require that you discontinue the procedure.(page 223) 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 h.6 and h.10.Corrected information is provided in h.10.Investigation: emergency use authorization (eua) note: the fda issued an emergency use authorization (eua) on april 10, 2020 for the use of the optia apheresis system combined with marker therapeutics' d2000 adsorption cartridge to treat patients 18 years of age or older with confirmed coronavirus disease 2019 (covid-19) admitted to the intensive care unit (icu) with confirmed or imminent respiratory failure to reduce pro-inflammatory cytokine levels.The devices work together by reducing the number of cytokines and other inflammatory mediators, i.E., small active proteins in the bloodstream that control a cell's immune response by filtering the blood and returning the filtered blood to the patient.A disposable complaint history review for lot 2007083230 found no other reports of this failure type.The total volume of ac used during a tpe-spd procedure is returned to the patient with the treated plasma.As a result, the patient¿s fluid balance is always positive at the end of the run.It is possible that the inlet: ac ratio was not adjusted from the default of 10:1 to minimize the additional volume for this patient.The customer submitted 2 videos to aid in the investigation.The first video was taken at some point during the procedure and shows tubing coming out of the spd column.The plasma inside the tubing is clumpy and an opaque white and confirms the presence of platelet aggregates.The second video shows the plasma being pushed through a syringe onto a gauze pad.Some of the plasma is a normal clear, yellow color but appears to be somewhat gelatinous.The remaining contents are 3 distinct, white clots.Correction: according to the terumo bct global clinical marketing manager, all sites for the eua clinical study are instructed to follow the direction to lower the inlet:ac ratio to 8 if clotting is suspected or occurring.They should process at least 100ml of inlet volume, then increase the inlet:ac ratio if the clotting has resolved.If not, the ratio should remain at 8 or lower until it has resolved.This information is in the training and is also the same instruction given for all procedures concerning clotting or clumping.If these guidelines are not adequate, sites may choose to utilize systemic anticoagulants pre/during the procedures for their covid patients since clotting is part of the disease process and can be difficult to predict and manage.Though terumo bct is not able to provide direction on this decision specifically, terumo bct clinical personnel can assist with connecting the physicians to those who have seen success to allow them to discuss further.Root cause: based on the customer's statements, the root cause of the pulmonary embolism was due to a dislodged thrombus, which initiated from the midline catheter and was present prior to the procedure.A definitive root cause for clotting could not be determined at this time.Potential causes include but are not limited to: - 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.- hypercoagulable state as a result of the patient's underlying disease - use of extension tubing connected to the patient's inlet line which was not anticoagulated.Corrected investigation: the statement according to the optia operator's manual provided in supplement 1 is no longer applicable to this investigation.
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Search Alerts/Recalls
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