Model Number 42000 |
Device Problems
No Apparent Adverse Event (3189); Insufficient Information (3190)
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Patient Problems
Hypervolemia (2664); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 01/30/2024 |
Event Type
malfunction
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Event Description
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The customer reported that during a procedure on a rika device 771 ml of saline was administered instead of the standard 500 ml.The set was examined for kinks and occlusions with none found, the saline bag was fully empty.Patient information and outcome are not available at this time.
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Manufacturer Narrative
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Investigation: a terumo bct service technician performed a recalibration and a cps calibration with failing results due to draw and return pump centrifuge pressure sensor values out of expected range.The technician then performed both draw and return pump cca auto tests with passing results.After those tests passed, the technician installed new tubing and hemostat and performed the cps calibration again.The machine failed due to the centrifuge pressure sensor values out of expected range.The technician transferred a second pressure transducer to the center and attempted the cps calibration again with failing results.Per the service manual, the technician replaced the tubing and verified that the connections were correct and attempted calibration again with failing results.The device was powered on and the technician performed a high pressure sensor calibration, cuff pressure sensor, centrifuge pressure sensor, access pressure sensor, weight station calibration successfully and performed all auto tests with passing results.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 procedure on a rika device 771 ml of saline was administered instead of the standard 500 ml.The set was examined for kinks and occlusions with none found, the saline bag was fully empty.Patient information and outcome are not available at this time.
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Manufacturer Narrative
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Investigation: a terumo bct service technician performed a recalibration and a cps calibration with failing results due to draw and return pump centrifuge pressure sensor values out of expected range.The technician then performed both draw and return pump cca auto tests with passing results.After those tests passed, the technician installed new tubing and hemostat and performed the cps calibration again.The machine failed due to the centrifuge pressure sensor values out of expected range.The technician transferred a second pressure transducer to the center and attempted the cps calibration again with failing results.Per the service manual, the technician replaced the tubing and verified that the connections were correct and attempted calibration again with failing results.The device was powered on and the technician performed a high pressure sensor calibration, cuff pressure sensor, centrifuge pressure sensor, access pressure sensor, weight station calibration successfully and performed all auto tests with passing results.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 confirmed that the calculated fluid balance was 18.94%.No further reporting will be provided as this does not represent a reportable event.
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Search Alerts/Recalls
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