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 08/05/2020 |
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 was able to confirm the reported condition.Per the service technician it was found the i.V.Pole adjustment screw needed adjusted.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.Per the customer the iv pole collar was in place and functioned as designed 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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This report is being filed to provide additional information in h.6 and h.10.Investigation: 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 one additional issue related to the reported condition identified as reported in 1722028-2020-00401.Correction: trima field action 30 has been was completed on january 2, 2019 to notify all trima users to use precaution while transporting the device and a caution statement was included in the operator's manual.Root cause: the root cause of this failure was the adjustment of the iv pole screw.
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Search Alerts/Recalls
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