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 09/09/2023 |
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.The iv pole clamp was installed.
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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 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 release screw.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 corrected information is provided in investigation: a terumo bct service technician checked out the machine at the customer site and was able to confirm the reported condition.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 (see mdr 1722028-2023-00271) 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.The iv pole clamp was installed.
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Search Alerts/Recalls
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