Model Number 50000000 |
Device Problems
Failure to Pump (1502); Failure to Calibrate (2440)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/17/2022 |
Event Type
malfunction
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Event Description
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It was reported that the biomed had an arctic sun device that failed the calibration for not cooling, it had a failed mixing pump and device was due for the 2000-hour preventive maintenance.
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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 device was not returned.
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Manufacturer Narrative
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The reported issue was confirmed.The root cause of the reported issue is a failed mixing pump.The device reportedly had a failed mixing pump and was due for the 2000-hour preventive maintenance.All good faith attempts have been made to obtain additional information.The outcome of the repair cannot be determined at this time.In the event that information regarding the outcome of the repair and the status of the device is received, this record will be reopened to update the investigation.It is known that the device did not meet specifications and that the device was influenced by the reported failure.The device was not in use on a patient.A review of the device history records did not show any problems or conditions that would have contributed to the reported issue.The complaint or reported issue was confirmed through other elements of the investigation to not be labeling or packaging related.Therefore labeling review was not required.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 device was not returned.
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Event Description
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It was reported that the biomed had an arctic sun device that failed the calibration for not cooling, it had a failed mixing pump and device was due for the 2000-hour preventive maintenance.
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Search Alerts/Recalls
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