Model Number 50000000E |
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 biomed was not near the arctic sun device, but stated it was foaming.Also stated that they would like to send the device in for 2000-hour service.Per follow up information received via email on 14-feb-2022, biomed was not around the device during the reported issue and would be sending in for repair and it was unknown the device was being used during reported event.Per sample evaluation results received on 15-aug-2022, the root cause was determined to be cavitation from a weak circulation pump causing micro bubbles to appear.The reported issue was confirmed and what appeared to be foaming in the water that turned out to be micro air bubbles passing through the test loops attached to the end of the fluid delivery line at startup of the circulation pump.After a few minutes the bubbles cleared.Windows error on control panel.Voice and chime through control panel speaker very faint at maximum speaker setting of 5.Double bend tube was noted to be 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.
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Event Description
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It was reported that the biomed was not near the arctic sun device, but stated it was foaming.Also stated that they would like to send the device in for 2000-hour service.Per follow up information received via email on 14-feb-2022, biomed was not around the device during the reported issue and would be sending in for repair and it was unknown the device was being used during reported event.Per sample evaluation results received on (b)(6) 2022, the root cause was determined to be cavitation from a weak circulation pump causing micro bubbles to appear.The reported issue was confirmed and what appeared to be foaming in the water that turned out to be micro air bubbles passing through the test loops attached to the end of the fluid delivery line at startup of the circulation pump.After a few minutes the bubbles cleared.Windows error on control panel.Voice and chime through control panel speaker very faint at maximum speaker setting of 5.Double bend tube was noted to be expanded.
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Manufacturer Narrative
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Upon further review, bd has determined that this mdr was reported in error as the event was 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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