Model Number 81000 |
Device Problems
Mechanical Problem (1384); Device Slipped (1584); Insufficient Information (3190)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/19/2023 |
Event Type
malfunction
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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 adverse event occurred and no medical intervention was required.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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Investigation is in process, a follow-up report will be provided.
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Manufacturer Narrative
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This report is being filed to provide.Invstigation: a terumo bct service technician checked out the machine at the customer site and confirmed that the screw holding the pole was loose.The service engineer tightened the screw and verified no problem with the iv pole.The device serial number history report indicates one further related issue has been reported for this device.One year of service history was reviewed for this device with one further issue related to the reported condition identified.Correction: a field service engineer adjusted the iv pole release screw.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 adverse event occurred and no medical intervention was required.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 invstigation: a terumo bct service technician checked out the machine at the customer site and confirmed that the screw holding the pole was loose.The service engineer tightened the screw and verified no problem with the iv pole.The device serial number history report indicates one further related issue has been reported for this device.One year of service history was reviewed for this device with one further issue related to the reported condition identified reported on mdr 1722028-2023-00361.Correction: a field service engineer adjusted the iv pole release screw.Root cause: a root cause assessment was performed for this complaint.The root cause was determined to be related the need for an iv pole 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 adverse event occurred and no medical intervention was required.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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