Model Number 42000 |
Device Problems
No Apparent Adverse Event (3189); Insufficient Information (3190)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/28/2024 |
Event Type
malfunction
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Event Description
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The customer reported that during rinseback on procedure the donor did not receive the complete saline amount due to a kink in the saline line.Per the customer, the device did not alarm, and the donation ended.It was noted that the donor received 700 ml of saline.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 mock procedure, fluid test, and operation qualifications per terumo service documents all with passing results.Investigation is in process, a follow up report will be provided.
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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 mock procedure, fluid test, and operation qualifications per terumo service documents all 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.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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Event Description
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The customer reported that during rinseback on procedure the donor did not receive the complete saline amount due to a kink in the saline line.Per the customer, the device did not alarm, and the donation ended.It was noted that the donor received 700 ml of saline.Patient information and outcome are unknown at this time.
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Search Alerts/Recalls
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