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 03/05/2024 |
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 fluid a test and received passing results.The technician also performed a mock procedure and the device initiated rinseback and returned sodium chloride (nacl) as expected.Device is operating as intended.Per the run data file (rdf) for this procedure, 880 ml of fluid (plasma + ac) was in the plasma bottle at the end of the run, which indicates this donor had a minimum weight of 175 lbs; and 138 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.Using nadler's equation for tbv, a worst-case donor for this donation volume would have a starting tbv of approximately 3454 ml.3454 ml - 880 ml = 2574 ml (2574 ml+138 ml-3454 ml) 3454 ml*100 = -21.48% fluid balance 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 plasma donation on a rika device, the donor did not receive enough saline at the end of the procedure.The operator did not realize the donor did not receive the full saline amount, until the donor had already left the facility and the device setup was taken down.No medical intervention was reported.Full donation id: (b)(6).Patient information and outcome are not available at this time.
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Event Description
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The customer reported that during a plasma donation on a rika device, the donor did not receive enough saline at the end of the procedure.The operator did not realize the donor did not receive the full saline amount, until the donor had already left the facility and the device setup was taken down.No medical intervention was reported.Full donation id: (b)(6).Patient information 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 investigation: a terumo bct service technician checked out the device at the customer site and performed a fluid a test and received passing results.The technician also performed a mock procedure and the device initiated rinseback and returned sodium chloride (nacl) as expected.Device is operating as intended.Per the run data file (rdf) for this procedure, 880 ml of fluid (plasma + ac) was in the plasma bottle at the end of the run, which indicates this donor had a minimum weight of 175 lbs; and 138 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.Using nadler's equation for tbv, a worst-case donor for this donation volume would have a starting tbv of approximately 3454 ml.3454 ml - 880 ml = 2574 ml (2574 ml+138 ml-3454 ml)/3454 ml*100 = -21.48% fluid balance after reaching out to the customer regarding this collection, they provided the following donor information: no medical intervention required on a 53 yo female with an hct of 46, 5' 6" and 216 pounds.Per the dlog, 880 ml of fluid (plasma + ac) was in the plasma bottle at the end of the run and 138 ml of saline was returned to the donor.Using nadler's equation for tbv, a worst-case donor for this donation volume would have a starting tbv of approximately 5102 ml.5102 ml - 880 ml = 4222 ml (4222 ml+138 ml-5102 ml)/5102 ml*100 = -14.54% 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.It was confirmed that the final fluid balance 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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