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 02/22/2024 |
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 successful fluid test.Per the customer, the device was missing the ac hook.Investigation is ongoing and a follow up report will be provided.
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Event Description
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The customer reported that a donor on rika was only able to donate 8 ml of plasma on rika device, then the device administered saline.Patient information and outcome are not known 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.Investigational a terumo bct service technician checked out the device at the customer site and performed a successful fluid test.Per the customer, the device was missing the ac hook.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 this event was below the 20% 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 a donor on rika was only able to donate 8 ml of plasma on rika device, then the device administered saline.Patient information and outcome are not known at this time.
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Search Alerts/Recalls
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