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 the circulation pump and mixing pump had failed on the arctic sun device.The customer would like to send the device to 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 the 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 the removal of pumps.It was also noted that double bend tubes and chiller evaporator tank outlet tubes 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 bd 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 bd.H3 other text: the actual/suspected device was inspected.
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Event Description
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It was reported that the circulation pump and mixing pump had failed on the arctic sun device.The customer would like to send the device to 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 the 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 the removal of pumps.It was also noted that double bend tubes and chiller evaporator tank outlet tubes were expanded.
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Search Alerts/Recalls
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