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 02/06/2024 |
Event Type
malfunction
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Event Description
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The customer reported that during a procedure on a rika device, 771 ml of saline was dispensed to the donor, with an intended 500 ml target.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 and performed a return pump auto test and fluid test with passing results.Per the run data file (rdf), this run was performed using nomogram a and 800 ml of plasma was in the plasma bottle at the end of the run; the donor weight was 204 lbs and 771 ml of saline was returned to the donor.A historical review of customer data indicated the minimum donor height was 4'3", so a worst-case minimum height is assumed to be 4' for this record.Since 771 ml of saline cannot be returned to the donor from a 500 ml bag, 0ml of saline returned will be assumed for this collection.Using nadler's equation for tbv, a worst-case donor for this donation volume would have a starting tbv of approximately 3890 ml.3890 ml - 800 ml = 3090 ml (3090 ml-0 ml-3890 ml)/3890 ml*100 = -20.57% fluid balance investigation in 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, 771 ml of saline was dispensed to the donor, with an intended 500 ml target.No medical intervention was reported.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 performed a return pump auto test and fluid test with passing results.After reaching out to the customer regarding this collection, they provided the following donor information: no medical intervention required on a 46 yo male with an hct of 46, 5' 7" and 204 pounds.Per the dlog, this run was performed using nomogram a and 800 ml of plasma was in the plasma bottle at the end of the run and 771 ml of saline was returned to the donor.Since 771 ml of saline cannot be returned to the donor from a 500 ml bag, 0ml of saline returned will be assumed for this collection.Using nadler's equation for tbv, a worst-case donor for this donation volume would have a starting tbv of approximately 5391 ml.5391 ml - 800 ml = 4591 ml (4591 ml-0 ml-5391 ml)/5391 ml*100 = -14.84% fluid balance 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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