Model Number 61000 |
Device Problems
Defective Component (2292); Device Displays Incorrect Message (2591)
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Patient Problem
No Known Impact Or Consequence To Patient (2692)
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Event Date 05/10/2018 |
Event Type
malfunction
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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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Event Description
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The customer reported they received a 'return line air detector failed' alarm.Patient information and outcome are not available at this time.
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Manufacturer Narrative
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This report is being filed to provide additional information and corrected information.
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Manufacturer Narrative
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This report is being filed to provide additional information.Investigation: further evaluation of this event has determined that the device did not cause or contribute to a death or serious injury, nor is there a likely potential for death or serious injury associated with this event based on additional investigational information.Follow up information indicated that the device presented a fail safe alarm.A terumo bct service technician checked out the machine at the customer site and a repair and preventative maintenance (pm) was performed.The rlad was found to be intermittent fault and was replaced.The pm was completed per manufacturer instructions.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 one issue related to the reported condition identified.The customer reported that the device alarmed 'return line air detector failed fluid check'.No service was involved for the reported condition as the device failed safe.Root cause: since the replacement of the return line air detector has resolved the issue, it is likely that this part was defective or a contributing factor.
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Event Description
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During follow-up it was determined that the alarm that occured for this event was return line air detector failed fluid check.Due to eu personal data protection laws, the patient information is not available from the customer.
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Search Alerts/Recalls
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