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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 07/26/2022 |
Event Type
malfunction
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Event Description
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It was reported that circulation pump and mixing pump had failed on the arctic sun device.The customer would like to send the device into the depot for repair.Per follow up information received on (b)(6) 2022 , no patient was involved.A quote had been sent to biomed, and would decide if device had to be sent in for repairs.Per sample evaluation results received on (b)(6) 2022 , it was noted that the tank seal was torn during removal of pumps.It was also noted that double bend tube and chiller evaporator tank outlet tube were expanded.
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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.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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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.H3 other text : the actual/suspected device was inspected.
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Event Description
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It was reported that circulation pump and mixing pump had failed on the arctic sun device.The customer would like to send the device into the depot for repair.Per follow up information received on 18-feb-2022, no patient was involved.A quote had been sent to biomed, and would decide if device had to be sent in for repairs.Per sample evaluation results received on 26-jul-2022, it was noted that the tank seal was torn during removal of pumps.It was also noted that double bend tube and chiller evaporator tank outlet tube were expanded.
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Search Alerts/Recalls
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