Model Number 50000000 |
Device Problem
Nonstandard Device (1420)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 08/15/2022 |
Event Type
malfunction
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Event Description
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It was reported that the arctic sun device had a failed mixing pump.The customer requested a quote for the 2000 hours service package.As per follow up information received on (b)(6) 2022 , there was no patient involvement during reported event and the device would be sent in for service and repair.As per sample evaluation results received on (b)(6) 2022 , the arctic sun device was primed to fill.It was noted that double-bent tubes were found during repairs to be expanded.It was also noted that the tank seals were found to be lifted from the tank.
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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.
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Event Description
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It was reported that the arctic sun device had a failed mixing pump.The customer requested a quote for the 2000 hours service package.As per follow up information received on 08feb2022, there was no patient involvement during reported event and the device would be sent in for service and repair.As per sample evaluation results received on 15aug2022, the arctic sun device was primed to fill.It was noted that double-bent tubes were found during repairs to be expanded.It was also noted that the tank seals were found to be lifted from the tank.Per sample evaluation results received on 31jan2023, the root cause was isolated to a faulty mixing pump.It was reported that the chiller evaporator tank outlet tube was expanded.It was noted that the double bend tube, chiller evaporator tank outlet tube was replaced with five new tank seals.
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Manufacturer Narrative
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Upon further review, bd has determined that this mdr was initially reported in error as this event is not reportable.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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Search Alerts/Recalls
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