Model Number 82410 |
Device Problems
No Display/Image (1183); Adverse Event Without Identified Device or Use Problem (2993); Pressure Problem (3012); Unexpected Shutdown (4019)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 08/08/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Lot number and expiry information are not available at this time 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 machine spontaneously shut down and the screen went black.The operator turned it off and on and started again.When she was entering the donor information, the screen suddenly went blue.The tubing set was already in place and the operator turned off and on again.Failure "# 61" appeared on the screen.The tubing set was removed after several attempts.A new set was set up and it did not pass the pressure test.Pet the customer, the cassette was properly positioned, the lines were on the pumps, the white clamps were closed, and the air was removed from the sample bag.These steps were repeated several times.Patient information and outcome are not available at tis time.The disposable set is not available for return because it was discarded by the customer.
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Manufacturer Narrative
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This report is being filed to provide additional information in a.1, b.5, h.6 and h.10 investigation: the customer submitted 4 photos to aid in the investigation.The first 3 images are screenshots following the alarms, which include the alarm description and directions for the operator.The 4th image is the disposable set loaded onto the cassette and lowered down around the pumps.The set does not contain fluid; no abnormalities are observed.The lines, clamps, and bags beyond the set are not visible.A review of the device history record (dhr) for this unit showed no irregularities during manufacturing that were relevant to this issue.Alarm (61) air removal failure.Pressure detected during bag evacuation ending run is generated when the evacuation pressure alert has been triggered for a third time.Preventive maintenance was performed on (b)(6) 2020.The device was verified to be operating per manufacturer specifications.Root cause : a specific root cause for the air in the sample bag could not be determined for this incident.Possible causes include: a clamp malfunction where the clamp skews to the side as it is closed, or the clamp does not fully occlude the tubing when closed due to interference between the clamp and the tube.Additional contributing factors could be related to user interface, where either the sample bag clamp was not closed at the system prompt or the clamp was closed but it was skewed on the tubing enabling a portion of the tubing to allow air to pass.A reboot of the system is a designed response to any unknown or abnormal state in any of the systems on the device.The root cause for the reported reboots in this incident could not be determined.Correction: trima field action 35 has been initiated to notify all trima users of a potential safety hazard occurs if the system displays an alert and instructions are not observed and followed.Terumo bct is taking corrective action by reminding all users of the action to be taken to mitigate this risk.Alerts and instructions are presented to the operator if the sample bag inflates.Terumo bct instructs all trima users to provide supplementary training and to continue to use the trima accel system in accordance with the operator¿s manual.Corrective action: an internal capa has been initiated to address pinch clamp no occluding the sample bag line consistently.
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Event Description
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The procedure was discontinued prior to connecting a donor, therefore, patient information is not reasonably known.
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Manufacturer Narrative
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This report is being filed to provide addiitional information in e.1.Investigation is in process.A follow up report will be provided.
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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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Search Alerts/Recalls
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