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Catalog Number 649225B4 |
Device Problem
Fluid/Blood Leak (1250)
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Patient Problem
No Patient Involvement (2645)
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Event Date 12/08/2020 |
Event Type
malfunction
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Manufacturer Narrative
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Initial reporter phone#: (b)(6).Medical device expiration date: na.A device evaluation is anticipated but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.(b)(4).
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Event Description
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It was reported that while using the bd lsrfortessa¿ leakage of biohazard was not contained within the instrument.There was no report of patient impact.The following information was provided by the initial reporter: the instrument is leaking from the sip when the support arm is moved to the side.Leak safety checklist: was the leak liquid or air? (if liquid/both, go to question #2.If air, no further questions required.): liquid.Was the leak contained within the instrument? ( if not contained, go to question #3.If contained, no further questions required.): not contained.Was there spray of liquid under pressure? (if yes, describe the liquid that sprayed then go to question #7.If no, type "no" in the text box then go to question #4): no.What was the fluid that leaked? (if non biohazard, no further questions required.If biohazard/unknown, go to question #5): biohazard.Did biohazard leak before or after waste line? (if before waste line or unknown, go to question #7.If after waste line, go to question #6): after waste line was the waste mixed with decontamination/bleach? (if no, go to question #7.If yes, no further questions required.): no.Was the customer/bd personnel physically in contact with the fluid? (if yes, go to question #8.If no, no further questions required.) physical contact includes: clothing, skin, mucous membrane, inhalation, and non-intact skin.: no.
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Event Description
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It was reported that while using the bd lsrfortessa¿ leakage of biohazard was not contained within the instrument.There was no report of patient impact.The following information was provided by the initial reporter: the instrument is leaking from the sip when the support arm is moved to the side.Leak safety checklist: was the leak liquid or air? (if liquid/both, go to question #2.If air, no further questions required.): liquid.Was the leak contained within the instrument? ( if not contained, go to question #3.If contained, no further questions required.): not contained.Was there spray of liquid under pressure? (if yes, describe the liquid that sprayed then go to question #7.If no, type "no" in the text box then go to question #4): no.What was the fluid that leaked? (if non biohazard, no further questions required.If biohazard/unknown, go to question #5): biohazard.Did biohazard leak before or after waste line? (if before waste line or unknown, go to question #7.If after waste line, go to question #6): after waste line.Was the waste mixed with decontamination/bleach? (if no, go to question #7.If yes, no further questions required.): no.Was the customer/bd personnel physically in contact with the fluid? (if yes, go to question #8.If no, no further questions required.) physical contact includes: clothing, skin, mucous membrane, inhalation, and non-intact skin.: no.
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Manufacturer Narrative
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After further review mfr#2916837-2021-00003 is no longer reportable.This device is for research use only and is not being used for diagnostic testing or patient treatment and is therefore not subject to mdr reporting.
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Search Alerts/Recalls
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