Catalog Number 10120 |
Device Problem
Insufficient Information (3190)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/01/2024 |
Event Type
malfunction
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Manufacturer Narrative
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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 machine priming on a spectra optia device, the machine displayed the error message "return air detector, test to verify liquid present in the return line failed".They were able to reload a new disposable set and continue the procedure.Upon review of the information by terumo bct it was noted that the incident date of the event was reported as 03/01/2024 and the set expired 08/01/2023.There was not a transfusion recipient or patient involved at the time of the event, therefore no patient information is reasonably known.Terumo bct is awaiting return of the disposable set for evaluation.
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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: an unused spectra optia disposable set was received for investigation.The set was found to be assembled correctly with no kinks or missing parts.No disposable defects were identified.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.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 machine priming on a spectra optia device, the machine displayed the error message "return air detector, test to verify liquid present in the return line failed".They were able to reload a new disposable set and continue the procedure.Upon review of the information by terumo bct it was noted that the incident date of the event was reported as (b)(6) 2024 and the set expired (b)(6) 2023.There was not a transfusion recipient or patient involved at the time of the event, therefore no patient information is reasonably known.Terumo bct is awaiting return of the disposable set for evaluation.
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Search Alerts/Recalls
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