Model Number 81000 |
Device Problems
Mechanical Problem (1384); Device Slipped (1584); Unintended Movement (3026)
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Patient Problem
No Patient Involvement (2645)
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Event Date 06/17/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Investigation: a terumo bct service technician checked out the machine at the customer site and confirmed the reported condition.It was found during inspection that the iv pole required adjustment and alignment.The iv pole was adjusted and aligned, and a substance was cleaned from the iv pole.The mechanism (screw and lock nut) were adjusted and the functionality was tested with no issues noted.The device serial number history report indicates no further related issues have been reported for this device.One year of service history was reviewed for this device with no other problems identified related to the reported condition.Corrective action: an internal capa has been initiated to evaluate reports of the iv pole dropping down suddenly.Implementation of the addition of a collar for the currently field installed devices will be completed to address 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 the iv pole on the trima equipment unexpectedly lowers down.No injury was reported for this incident and no patient was connected at the time the iv pole was sliding down, therefore no patient information is reasonably known.
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Manufacturer Narrative
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Root cause: the root cause of this failure was a mis-aligned lock nut screw.Corrected corrective action: the corrective action statement provided in the initial mdr is not applicable for this event and have been removed from the investiation.
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Search Alerts/Recalls
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