Model Number 81000 |
Device Problems
Mechanical Problem (1384); Device Slipped (1584)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 11/09/2021 |
Event Type
malfunction
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Manufacturer Narrative
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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 h.6 and h.10.Investigation: a terumo bct service technician inspected the machine at the customer site.The technician adjusted/aligned the iv pole screw, side panel and iv pole button screw.The technician confirmed the iv pole was operational and had pole collar installed.The machine was returned to service.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 h.6 and h.10.Investigation: a terumo bct service technician inspected the machine at the customer site.The technician adjusted/aligned the iv pole screw, side panel and iv pole button screw.The technician confirmed the iv pole was operational and had pole collar installed.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.Root cause: a root cause assessment was performed for this complaint.The root cause was determined to be the need for a screw adjustment.
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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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Search Alerts/Recalls
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