Catalog Number 10310 |
Device Problems
Adverse Event Without Identified Device or Use Problem (2993); Insufficient Information (3190)
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Patient Problem
Hypervolemia (2664)
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Event Date 12/14/2022 |
Event Type
malfunction
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Event Description
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The customer reported that during a continuous mononuclear cell (cmnc) collection procedure on a spectra optia device, the saline line continued to drip.The operator had placed a hemostat below the drip chamber.Terumo bct support asked the operator to check the roller clamps and the red roller clamp was still open.It was reported that about 600 mls of normal saline (ns) that went to the patient.Per calculations the final fluid balance = 146.7 % patient age, weight and outcome are not available at this time.The collection set is not available for return because it was discarded by the customer.
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Manufacturer Narrative
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Investigation: final adjusted fluid balance = (1741 ml + 600 ml +5017 ml) / 5017 ml x 100% = 146.7 % investigation is in process.A follow-up report will be provided.
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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: final adjusted fluid balance = (1741 ml + 600 ml +5017 ml) / 5017 ml x 100% = 146.7 % the device history records (dhr) were reviewed for this lot. there were no events noted in the dhr that would have contributed to the elevated wbc count experienced by the customer.A disposable complaint history search was performed for this lot and found no reports for similar issues (mis-clamping user errors) on this lot worldwide.Root cause: based on the information provided, the cause for the unintended saline bolus was an operator error in which the red (inlet) saline roller clamp was inadvertently left open.
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Event Description
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The customer reported that during a continuous mononuclear cell (cmnc) collection procedure on a spectra optia device, the saline line continued to drip.The operator had placed a hemostat below the drip chamber.Terumo bct support asked the operator to check the roller clamps and the red roller clamp was still open.It was reported that about 600 mls of normal saline (ns) that went to the patient.Per calculations the final fluid balance = 146.7 % patient age and outcome are not available at this time.The collection set is not available for return because it was discarded by the customer.
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Search Alerts/Recalls
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