Model Number SCCS1002 |
Device Problem
Device Sensing Problem (2917)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/04/2022 |
Event Type
malfunction
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Event Description
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It was reported that the engineering test unit have noted that the sensica device was always detecting the tube even when was disconnected which means false positive id issue.They believe the two tube issue devices needed the optical sensor repair (serial# bmgnrms034) and (serial# (b)(4).
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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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Manufacturer Narrative
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Upon further review, bd has determined that this mdr was reported in error as it was found that there was no allegation against product.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.
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Event Description
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It was reported that the engineering test unit have noted that the sensica device was always detecting the tube even when was disconnected which means false positive id issue.They believe the two tube issue devices needed the optical sensor repair (serial# (b)(6)) and (serial# (b)(6)).
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Search Alerts/Recalls
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