Model Number 81012 |
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 03/19/2020 |
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 found that the iv pole easily fell down.The technician adjusted the press button and the machine was returned to service.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.Correction: trima field action 30 has been initiated to notify all trima users to use precaution while transporting the device and a caution statement was included in the operator's manual.It was confirmed by the customer that the iv pole clamp was installed on this device at the time of the incident.Corrective action: an internal capa has been initiated to evaluate reports of the iv pole dropping down suddenly.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 and no medical intervention was required.
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Event Description
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This product is not available within the us, but this report is being filed due to an alleged failure that could occur on a similarly marketed device platform cleared for use by the fda.
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Manufacturer Narrative
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This report is being filed to provide additional information in b.5, h.6, and h.10.The 510k provided in the intial mdr is not relevent to this case.Root cause: the root cause of this failure was a misalignment of the release button.
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Search Alerts/Recalls
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