Model Number 42000 |
Device Problems
No Apparent Adverse Event (3189); Insufficient Information (3190)
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Patient Problems
Hypovolemia (2243); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/03/2024 |
Event Type
malfunction
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Manufacturer Narrative
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Investigation: a terumo bct service technician checked out the device at the customer site and performed auto tests on the ac pump cca, multifunction cca, and a fluid test all with passing results.The technician also inspected and found no obstructions or foreign objects in the centrifuge basin and replaced the centrifuge motor.Investigation is in process and 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, the device was removed from service due to alarm "not at target speed".The donor was disconnected, and the procedure was discontinued.Per the customer, less than 200 ml cell loss was recorded.Patient information and outcome are unknown at this time.
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Manufacturer Narrative
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Investigation: a terumo bct service technician checked out the device at the customer site and performed auto tests on the ac pump cca, multifunction cca, and a fluid test all with passing results.The technician also inspected and found no obstructions or foreign objects in the centrifuge basin and replaced the centrifuge motor.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 final fluid balance was within the (b)(4) threshold.No further reporting will be provided as this does not represent a reportable event.
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Event Description
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The customer reported that during a procedure on a rika device, the device was removed from service due to alarm "not at target speed".The donor was disconnected, and the procedure was discontinued.Per the customer, less than 200 ml cell loss was recorded.Patient information and outcome are unknown at this time.
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Search Alerts/Recalls
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