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 03/15/2024 |
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 replaced the dual valve assembly and calibrated the weight station.The technician also performed an auto test and fluid test 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 only partial saline was administered to the donor.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 replaced the dual valve assembly and calibrated the weight station.The technician also performed an auto test and fluid test 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.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 during a procedure on a rika device only partial saline was administered to the donor.Patient information and outcome are unknown at this time.
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Search Alerts/Recalls
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