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 03/12/2024 |
Event Type
malfunction
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Manufacturer Narrative
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Investigation is in process, a follow-up report will be provided.
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Event Description
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Customer reported a potential over collection on a rika device.Patient information and outcome are unknown at this time.
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Event Description
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Customer reported a potential overcollection on a rika device.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 in h.6 and h.11.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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Search Alerts/Recalls
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