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 02/12/2024 |
Event Type
malfunction
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Event Description
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The customer reported that during unloading of a rika device.Blood was still in the separation channel.The device indicated that the entire rinse back was finished with no alarms.Less than 50% of the channel was full of only blood.Full donor id: (b)(6) donor age, gender, weight and outcome are not available at this time.
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Manufacturer Narrative
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Investigation: a terumo bct technician checked out the device at the customer site and performed a fluid test and functional verification successfully.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 unloading of a rika device.Blood was still in the separation channel.The device indicated that the entire rinse back was finished with no alarms.Less than 50% of the channel was full of only blood.Full donor id: id (b)(6) donor age, gender, weight and outcome are not available 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 technician checked out the device at the customer site and performed a fluid test and functional verification successfully.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 run was within the +/- 20% threshold.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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