Catalog Number 12220 |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); No Apparent Adverse Event (3189)
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Patient Problems
Hemolysis (1886); No Consequences Or Impact To Patient (2199)
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Event Date 04/07/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Investigation: review of the equipment showed that the aperture plate was dirty and cloudy and should be replaced.A dirty aperture plate can cause the lighting to diffuse differently and can cause these alarms.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 an exchange procedure using a spectra optia device, hemolysis occurred.Per the customer they ended the procedure and restarted with a new set.During this subsequent procedure, hemolysis was seen again.The procedure was terminated.Patient id, age and outcome are not available at this time.Terumo bct is awaiting the return of the disposable set.
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Manufacturer Narrative
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This report is being filed to provide additional information in b.6 and h.10.Corrected information is provided in b.6.Investigation: the run data file (rdf) was analyzed for this event.Review of the rdf confirms the occurrences of the ¿cells were detected in plasma line from centrifuge¿ alarms and ¿system continued to detect cells in plasma line from centrifuge¿ alarms throughout the procedures.The system generates the alarms when the rbc detector detects a red/green ratio greater than 1.5 during procedures.The alarm may occur for various reasons including air bubble(s) at the rbc detector, the entered patient hematocrit was too low, a shift in fluid balance caused the actual hematocrit to increase, patient related physiology, hemolysis and or clumping or issues with the rbc detector.Review of the images shows that the aperture plate may be a little dirty and likely needs to be replaced.Although this may not be the definitive reasons for the alarms, it can contribute.Review of the images also shows the interface is high in some of the procedures.Ensure the correct patient hematocrit is entered for this procedure.Investigation is in process.A follow up report will be provided.
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Manufacturer Narrative
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Investigation: further evaluation of this event has determined that the device did not cause or contribute to a death or serious injury, nor is there a likely potential for death or serious injury associated with this event based on additional investigational information.It was determined that hemolysis did not occur.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.The customer returned one used optia set for investigation containing blood.Visual inspection confirmed the set was assembled correctly with no kinks, leaks or defective parts.The inlet/return and replace lines were rf sealed.Flow of blood was verified throughout the cassette fluid pathway, loop, channel assembly and return reservoir with no occlusions found.There was no evidence of clumping or clotting within the inlet line trap, connector for return reservoir filter.A witness mark on the lower hex suggested the set was not optimally loaded into the centrifuge filler.The blood appeared dark red in colour throughout the set.Although most of the hemoglobin was oxidised within the tubing set (due to the length of time for the set return), there was evidence of separation of red cells in the plasma pump tubing, which indicated an rbc spillover as opposed to hemolysis.Investigation is in process.A follow up report will be provided.
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Event Description
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Pursuant to european union general data protection regulation 2016/679 on the protection of individuals with regard to the processing of personal data and on the free movement of such data, the patient identifier and age are 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 h.6 and h.10.Corrected information is provided in h.3.Root cause: a definitive root cause for the reported hemolysis could not be determined.Review of the dlogs associated with these complaints confirms the occurrences of the ¿cells were detected in plasma line from centrifuge¿ alarms and ¿system continued to detect cells in plasma line from centrifuge¿ alarms throughout the procedures.The system generates the alarms when the rbc detector detects a red/green ratio greater than 1.5 during procedures.The alarm may occur for various reasons including air bubble(s) at the rbc detector, the entered patient hematocrit was too low, a shift in fluid balance caused the actual hematocrit to increase, patient related physiology, hemolysis and or clumping or issues with the rbc detector.Review of the images shows that the aperture plate may be a little dirty and likely needs to be replaced.Although this may not be the definitive reasons for the alarms, it can contribute.Review of the images also shows the interface is high in some of the procedures.Ensure the correct patient hematocrit is entered for this procedure.
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Search Alerts/Recalls
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