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 03/16/2024 |
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 a mock procedure and a fluid test with passing results.The device returned all fluids and saline (nacl) as expected, and the service technician determined that the device was operating as intended.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 at the end of a donor's donation on a rika device, the device stated that the donor donated 825 ml.The operator reported that the color in the tube was light pink when taking down the set-up, and the centrifuged was full and not empty.Patient information and outcome are unknown at this time.
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Manufacturer Narrative
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This report is being filed to provide additional information in h.6 and h.11.Investigation: a terumo bct service technician checked out the device at the customer site and performed a mock procedure and a fluid test with passing results.The device returned all fluids and saline (nacl) as expected, and the service technician determined that the device was operating as intended.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.Per terumobct internal risk associated with hypovolemia for the rika plasma donation system, this complaint does not meet the requirements for reportability.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 at the end of a donor's donation on a rika device, the device stated that the donor donated 825 ml.The operator reported that the color in the tube was light pink when taking down the set-up, and the centrifuged was full and not empty.Patient information and outcome are unknown at this time.
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Search Alerts/Recalls
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