Catalog Number EXACTAM |
Device Problem
Break (1069)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 07/07/2023 |
Event Type
malfunction
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Event Description
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It was reported that the main module door of an exactamix automated compounding device (acd) was damaged.The damaged door was further described as, ¿in fault state / door that houses rotor and tubing won't close.Is unhinged¿.This issue was observed during an unspecified process step prior to patient use.There was no patient involvement.No additional information is available.
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Manufacturer Narrative
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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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Manufacturer Narrative
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H10: the device was received for evaluation.A visual inspection was performed which observed the device was in used condition.The unit was in a constant pump fault state and the pump door cover was missing a shoulder screw.An electrical safety test was performed in which the device passed testing.Functional system level tests were performed which found the pump was faulted.The reported conditions were verified.The cause of the reported condition of the pump fault was due to a faulty pump motor driver pca with an overheated (blown) chip and the cause of the unhinged pump door cover due to the missing screw; it is unknown how screw became missing.The pump motor and door will be replaced to resolve the issue.A service history review was performed which revealed that the device had no service history within the past 12 months.Should additional relevant information become available, a supplemental report will be submitted.
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Search Alerts/Recalls
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