Model Number 81000 |
Device Problems
Mechanical Problem (1384); Device Slipped (1584)
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Patient Problem
No Patient Involvement (2645)
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Event Date 08/18/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Investigation: per the customer, the iv pole clamp was installed on the device, but was not installed at the time the iv pole was unexpectedly lowering.A terumo bct service technician checked out the machine at the customer site as was able to confirm the reported condition.The technician found that the iv pole was falling with nothing on it.The technician adjusted/aligned the push button/screw on the inside of the panel.The iv pole was successfully tested and returned to service.One year of service history was reviewed for this device with no issues related to the reported condition identified.The device serial number history report indicates no further related issues have been reported for this device.Correction: the iv pole clamp was installed on this device on (b)(6) 2018 per fa 30.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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This report is being filed to provide additional information in e.3, h.6 and h.10.Root cause: the root cause of this failure was the button/screw on the inside of the panel needed adjustment.
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Search Alerts/Recalls
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