Catalog Number 50000000 |
Device Problems
Decreased Pump Speed (1500); Gas/Air Leak (2946)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 04/01/2024 |
Event Type
malfunction
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Event Description
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It was reported that arctic sun device would not fill.A check of the diagnostics showed inlet pressure (ip) only at -0.6 with circulation pump command (cpc) was 100 percentage during filling.Discussed that this was indicative of a failed circulation pump.They would repair device onsite.
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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.H3 other text : the device was not returned.
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Manufacturer Narrative
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The reported issue was confirmed.The root cause identified as a circulation pump failure.A dhr is not required as this is not an out-of-box failure.The reported issue was confirmed through other elements of the investigation to not be labeling or packaging related.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.H3 other text: the device was not returned.
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Event Description
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It was reported that arctic sun device would not fill.A check of the diagnostics showed inlet pressure (ip) only at -0.6 with circulation pump command (cpc) was 100 percentage during filling.Discussed that this was indicative of a failed circulation pump.They would repair device onsite.
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Search Alerts/Recalls
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