Catalog Number 5000-01-01 |
Device Problems
Inaccurate Flow Rate (1249); Decreased Pump Speed (1500)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 03/25/2024 |
Event Type
malfunction
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Event Description
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It was reported that there was insufficient flow in an arctic sun device.Per review of wo on 26mar2024, there was no patient injury reported.
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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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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 actual/suspected device was inspected.
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Event Description
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It was reported that there was insufficient flow in an arctic sun device.Per review of wo on (b)(6) 2024, no patient injury reported.Per follow up information received via email on 25apr2024, repair was done onsite.The circulation pump was replaced and was not working correctly.No patient impact reported.
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Search Alerts/Recalls
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