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 03/13/2024 |
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 on 3/13/2024 and performed a mock procedure and a fluid test with passing results and determined that the device was working as intended and was unable to identify any problems.On 3/21/2024 a terumo bct service technician performed a rika operation and performance qualifications with passing results.Investigation is in progress and 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, the device indicated that the donor received 771 ml of saline.No kinks were noted, and the saline bag was empty at the end of the procedure, and the device did not alarm.No medical intervention was reported.Patient information and outcome are unknown at this time.
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Manufacturer Narrative
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Investigation: a terumo bct service technician checked out the device at the customer site on (b)(6) 2024 and performed a mock procedure and a fluid test with passing results and determined that the device was working as intended and was unable to identify any problems.On (b)(6) 2024 a terumo bct service technician performed a rika operation and performance qualifications 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, the device indicated that the donor received 771 ml of saline.No kinks were noted, and the saline bag was empty at the end of the procedure, and the device did not alarm.No medical intervention was reported.Patient information and outcome are unknown at this time.
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Search Alerts/Recalls
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