Catalog Number 50000000 |
Device Problems
Circuit Failure (1089); Electrical Shorting (2926)
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Patient Problems
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581); No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/19/2023 |
Event Type
malfunction
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Manufacturer Narrative
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The investigation is still in progress.Once the investigation is complete a supplemental report will be filed.H11: section a through f - the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
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Event Description
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It was reported that alarm 74 (non-recoverable system error) occurred in arctic sun device.Planed to replaced tank harness.
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Manufacturer Narrative
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Upon further review, bd has determined that this mdr is not reportable.H11: section a through f - the information provided by bd represents all the known information at this time.Despite good faith efforts to obtain additional information, the complainant / reporter was unable or unwilling to provide any further patient, product, or procedural details to bd.
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Event Description
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It was reported that alarm 74 (non-recoverable system error) occurred in arctic sun device.Planed to replaced tank harness.Per follow up information received on (b)(6), 2023.The device currently being investigated by imi.Patient involved.Treatment was completed using the same device.No patient impacted.
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Search Alerts/Recalls
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