Catalog Number EXACTAM |
Device Problem
Device Emits Odor (1425)
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Patient Problem
No Patient Involvement (2645)
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Event Date 12/23/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Initial reporter address: (b)(6).The device has been received and the evaluation is in progress.Should additional relevant information become available, a supplemental report will be submitted.
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Event Description
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It was reported that the main module of an exactamix automated compounding device had a burning smell while powered on.There was no patient involvement.No additional information is available.
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Manufacturer Narrative
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Correction made to h10: a device history review was not performed, (previously submitted, as a device history review revealed, no issues that could have caused or contributed to the reported issue).
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Manufacturer Narrative
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Additional information in h3 and h6.H10: the device was received for evaluation.A visual inspection was performed and discovered that the pump stepper motor driver pca has burnt components (u12).It's possibly caused by a voltage surge and/or faulty components.The reported condition was verified.The burnt smell, unable to start pump because the home position is invalid and ctf (sf2) failed the pump is faulted.To correct the condition, the pump motor driver pca (p/n 6300-0137) will be replaced during refurbishment to prevent future recurrence of pump is in a fault state errors.A device history review revealed no issues that could have caused or contributed to the reported issue.Should additional relevant information become available, a supplemental report will be submitted.
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Search Alerts/Recalls
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