Catalog Number 5000-01-01 |
Device Problem
Disconnection (1171)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 09/11/2023 |
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 there was a temperature problem in an arctic sun device that was not cooling under 24°c.No water in chiller tank, chiller temperature (t4) was 24 ° c.The connector of the mixing pump was disconnected.Per review of wo on 18sep2023, there was no patient involvement.
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Manufacturer Narrative
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Upon further review, bd has determined that this mdr was reported in error as it was found to be a duplicate of an event previously reported.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 there was a temperature problem in an arctic sun device that was not cooling under 24°c.No water in chiller tank, chiller temperature (t4) was 24 ° c.The connector of the mixing pump was disconnected.Per review of wo on 18sep2023, there was no patient involvement.
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Search Alerts/Recalls
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