Model Number 3810002 |
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 02/19/2024 |
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.A pm was completed per manufacturers instructions and the iv pole retention system was adjusted.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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Event Description
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The customer reported that the iv pole on the trima equipment unexpectedly lowers down.An iv pole safety collar is installed on the device.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 additional information in b.5, h.6 and h.11.Investigation: a terumo bct service technician checked out the machine at the customer site.A pm was completed per manufacturers instructions and the iv pole retention system was adjusted.One year of service history was reviewed for this device with no further 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: a field service engineer adjusted the iv pole retention system.Root cause: a root cause assessment was performed for this complaint.The root cause was determined to be related to the need for an adjustment of the iv pole retention system.
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Search Alerts/Recalls
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