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 12/02/2022 |
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.
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Event Description
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It was reported that biomed stated the arctic sun device was not able to generate flow during testing.A functional check showed that the circulation pump could not maintain inlet pressure at -7psi around a pump speed of less than 63 percent.Mss discussed that this was indicative of a failing circulation pump and the option of replacing it locally or sending it in for 2000 hours service package.As per follow up information received on 05may2022, technical support and biomed stated that there was no patient involvement during reported event.Biomed would sending the device for 2000 hours preventive maintenance service.As per sample evaluation result received on 14jun2022, during decontamination the arctic sun device was primed to fill.It was noted that debris was observed passing through shunts during decontamination.It was also noted that the chiller to outer shell mounting bolt broken off inside nut plate.As per sample evaluation results received on 02dec2022, tank seals were replaced due to signs of wear.The evaporator outlet tube and double bend tube to the manifold were replaced due to expansion beyond specification.
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Event Description
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It was reported that biomed stated the arctic sun device was not able to generate flow during testing.A functional check showed that the circulation pump could not maintain inlet pressure at -7psi around a pump speed of less than 63 percent.Mss discussed that this was indicative of a failing circulation pump and the option of replacing it locally or sending it in for 2000 hours service package.As per follow up information received on 05may2022, technical support and biomed stated that there was no patient involvement during reported event.Biomed would sending the device for 2000 hours preventive maintenance service.As per sample evaluation result received on (b)(6) 2022, during decontamination the arctic sun device was primed to fill.It was noted that debris was observed passing through shunts during decontamination.It was also noted that the chiller to outer shell mounting bolt broken off inside nut plate.As per sample evaluation results received on (b)(6) 2022, tank seals were replaced due to signs of wear.The evaporator outlet tube and double bend tube to the manifold were replaced due to expansion beyond specification.
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Manufacturer Narrative
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Upon further review, bd has determined that this event is not reportable.H11: section a through f - the information provided by bard represents all of 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 bard.
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Search Alerts/Recalls
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