Catalog Number 12220 |
Device Problems
Occlusion Within Device (1423); Improper or Incorrect Procedure or Method (2017)
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Patient Problems
No Known Impact Or Consequence To Patient (2692); No Information (3190)
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Event Date 10/25/2016 |
Event Type
malfunction
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Manufacturer Narrative
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Investigation: per the customer, the operator broke the frangible on the acda bag.The acda bag was inspected and it was noted that the bottom part of the frangible was detached, however, the top frangible was still attached and occluded the opening of the acda bag.The customer stated that the 1st 450 ml of acda solution bag was emptied and 131 mls of acda were used from the 2nd acda bag.However, the optia machine displayed that 50 ml was drawn into the machine.The rdf was analyzed for this event.Review of the rdf and associated images for this procedure confirmed the presence of clumping in the connector starting approximately 8 minutes into the procedure.These signals suggest that the initial clumping experienced during this procedure was likely related to the patient¿s individual blood physiology and inadequate anticoagulation of the extracorporeal circuit.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 clumping in the connector.It is also noted that the clumping worsened even further toward the end of the procedure and eventually turned into significant clotting after the second ac bag was hung.Per the local clinical specialist, the second bag of ac was a 500 ml bag.The total ac used during this procedure was 899 ml; therefore, approximately 150 ml of ac should have been removed from the second bag.However, the complaint description indicated that 450 ml of ac were remaining in the second ac at the end of the procedure ¿ only 50 ml had actually been consumed by the system.Given the development of more severe clumping after the ac bag was changed, an occlusion in the ac line after this bag change cannot be ruled out as a cause of the exacerbated clumping toward the end of the procedure.Possible causes for this include the ac line becoming partially occluded as a result of loading into the ac fluid detector or by some component near the ac line such as a blood warmer, or an incomplete break of the frangible on the correct connect system.The signals in the run data file indicate that the ac fluid detector was functioning as intended,as the sensor saw fluid in the ac line during ac prime, at the beginning of the procedure, and throughout the run.There were no alarms during ac prime to suggest an occlusion was present in the ac line at the start of the procedure.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 therapeutic plasma exchange (tpe) procedure, they observed clotting in the tpe set.While the operator hung the second anti-coagulant (acda)solution bag, it was discovered that the set was clotted.The procedure was ended without rinseback.Patient outcome, identifier and age are not available at this time.Patient's gender and weight were obtained from the run data file (rdf).The tpe set is not available for return because it was discarded by the customer.
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Manufacturer Narrative
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A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Root cause: review of the run data file (rdf) for this procedure confirmed the presence of clumping in the connector.Signals suggest that the initial clumping experienced during this procedure was likely related to the patient¿s individual blood physiology and inadequate anticoagulation of the extracorporeal circuit.Given the development of more severe clumping after the ac bag was changed, per the rdfsignals, an occlusion in the ac line after this bag change cannot be ruled out as a cause of the exacerbated clumping toward the end of the procedure.Possible causes for this include the ac line becoming partially occluded as a result of loading into the ac fluid detector or by some component near the ac line such as a blood warmer, or an incomplete break of the frangible on the correct connect system.In either case, this could have caused fluid to be consistently present at the ac fluid detector, while limiting flowthrough the ac line at the same time.There were no alarms during ac prime to suggest an occlusion was present in the ac line at the start of the procedure.
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Event Description
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The customer declined to provide patient identifier, age, and outcome.
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Manufacturer Narrative
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This report is being filed to provide additional information.Correction: terumo bct national clinical manager confirmed that the operators have been re-trained by tbct staff.
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Event Description
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No medical intervention was required for this event.
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Search Alerts/Recalls
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