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 07/24/2023 |
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 and was able to confirm the reported condition.The technician adjusted the side panel button.Per the technician the ¿problem was that the vibration resulted in the iv-pole going down little by little.¿ 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.Correction: a field service engineer adjusted the iv pole button.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.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 h.6 and h.10.Investigation: a terumo bct service technician checked out the machine at the customer site and was able to confirm the reported condition.The technician adjusted the side panel button.Per the technician the problem was that the vibration resulted in the iv-pole going down little by little.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.Correction: a field service engineer adjusted the iv pole button.Root cause: a root cause assessment was performed for this complaint.The root cause was determined to be related to the need for an iv pole button 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.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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Search Alerts/Recalls
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