Catalog Number 50000000E |
Device Problems
Restricted Flow rate (1248); 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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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 biomed had an arctic sun device that wouldn't fill, and device didn't have any vacuum.They were going to order a new circulation pump and the stem hours to see if it was due for the 2000 hour pm and gave the other part numbers to complete the 2000 hour pm.
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Event Description
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It was reported that biomed had an arctic sun device that wouldn't fill, and device didn't have any vacuum.They were going to order a new circulation pump and the stem hours to see if it was due for the 2000 hour pm and gave the other part numbers to complete the 2000 hour pm.
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Manufacturer Narrative
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The reported issue was confirmed.The root cause identified as a circulation pump failure.They were going to order a new circulation pump and the stem hours to see if it was due for the 2000-hour pm and gave the other part numbers to complete the 2000-hour pm.All good faith attempts have been made to obtain additional information.The outcome of the repair cannot be determined at this time.In the event that information regarding the outcome of the repair and the status of the device is received, this record will be reopened to update the investigation.Dhr is not required as this is not an out-of-box failure.The labelling review is not required as the complaint or reported issue was confirmed through other elements of the investigation to not be labeling or packaging related.Correction: f,h.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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Search Alerts/Recalls
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