Model Number 81000 |
Device Problems
Component Falling (1105); Device Operates Differently Than Expected (2913)
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Patient Problem
No Patient Involvement (2645)
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Event Date 09/12/2017 |
Event Type
malfunction
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Manufacturer Narrative
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Maintenance review investigation: a terumo bct service technician checked out the device at the customer site and was able to duplicate the reported condition.The service technician noticed that the internal screw located at the push button was loose and the technician put pressure on the iv pole which caused premature lowering.The screw was tightened until slightly recessed.A functional test was successfully performed on the iv pole and determined that the iv pole was operational after the repair.The machine was returned to service.An internal report shows that the machine has been in use with no further occurrences of the problem.One year of service history was reviewed for this device with no problems identified related to the reported condition.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 machine unexpectedly lowers down.Per the customer, the iv pole 'spontaneously' falls down approximately 2 inches.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.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.Corrective action: an internal capa has been initiated to evaluate reports of the iv pole dropping down suddenly.Root cause: the root cause was the iv pole push button screw had loosened prompting the iv pole to slip.
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Search Alerts/Recalls
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