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 08/31/2023 |
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: a terumo bct service technician checked out the machine at the customer site and was able to confirm the reported condition.The technician also confirmed that the iv pole safety collar was in place.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 issues related to the reported condition identified.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 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 also confirmed that the iv pole safety collar was in place.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 issues related to the reported condition identified.Correction: a field service engineer performed an alignment/adjustment.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 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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