Catalog Number 50000000 |
Device Problems
Failure to Pump (1502); Failure to Calibrate (2440)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 02/27/2024 |
Event Type
malfunction
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Event Description
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It was reported that biomed had the artic sun device that was not cooling they tried to do the calibration and it failed for an error 80(water check time out unable to reach calibration temperature) for not cooling, confirmed mixing pump had failed and the device was due for the 2000-hour preventive maintenance, sending quote for service.Per sample evaluation results on (b)(6) 2024, it was reported that the hot side connection between the ac main voltage circuit card and the power inlet module shows signs of electrical overstress.Tanks seals had dry rot and cracking.Mixing pump motor had bearing that was seizing.
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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 the arctic sun device that was not cooling they tried to do the calibration and it failed for an error 80(water check timeout - unable to reach calibration temperature) for not cooling, confirmed mixing pump had failed and the device was due for the 2000-hour preventive maintenance, sending quote for service.Per sample evaluation results on 14mar2024, it was reported that the hot side connection between the ac main voltage circuit card and the power inlet module shows signs of electrical overstress.Tanks seals had dry rot and cracking.Mixing pump motor had bearing that was seizing.
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Manufacturer Narrative
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The reported issue was confirmed.The root cause identified is a failed mixing pump.The device was evaluated upon receipt.Confirmed not cooling during decontamination.Serviced mixing pump.A dhr is not required as the reported event is not an out of box failure and therefore the reported event is not manufacturing related.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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Search Alerts/Recalls
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