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Catalog Number 50000000 |
Device Problem
Gas/Air Leak (2946)
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Patient Problem
Appropriate Clinical Signs, Symptoms, Conditions Term / Code Not Available (4581)
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Event Date 04/03/2024 |
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.H3 other text : the device was not returned.
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Event Description
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It was reported that biomed received the arctic sun device because the circulation pump was making excessive amount of noise, had them start the unit and they could hear a rumbling noise over the phone, the unit was running in bypass with only the fluid delivery line (fdl) connected and flow rate (fr) was 1.9 lpm, inlet pressure (ip) was -7.7 psi, circulation pump command (cpc) was 64 %.They said it was just received back from the depot in january for the 2000-hour preventive maintenance, coming back under warranty.
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Search Alerts/Recalls
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