Catalog Number 650686 |
Device Problem
Leak/Splash (1354)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Date 10/07/2022 |
Event Type
malfunction
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Manufacturer Narrative
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Common device name: automated pipetting, diluting and specimen processing workstations for flow cytometric analysis.A device evaluation is anticipated, but has not yet begun.Upon completion of the investigation, a supplemental report will be filed.
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Event Description
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It was reported that while using the bd facs¿ sample prep assistant that the wash.Tower is leaking.The following information was provided by the initial reporter.The wash tower is leaking.
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Manufacturer Narrative
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H.6 investigation summary (b)(4).Pn: 650686 spaiii sn: (b)(6) awareness: 10/07/2022 opened: 10/07/2022.Investigation summary: ¿ scope of issue: the scope of issue is limited to part: 650686 spaiii and serial number: (b)(6).¿ problem statement: customer reported: wash tower is leaking.¿ manufacturing defect trend: there are 0 qns related to the reported issue.Date range (date of incident to 12 months back) from 07oct2021 to date 07oct2022 (rolling 12 months).¿ complaint trend: there are 4 complaints related to the reported complaint.Date range (date of incident to 12 months back) from 07oct2021 to date 07oct2022 (rolling 12 months) o (b)(4) (this complaint).¿ investigation result / analysis: per fse¿s report: unplugged (unclogged) system filter assembly.Instrument passed all required test.O no further issues o sample preparation was not affected.O there was no delay in patient treatment due to any unexpected results.¿ service max review: review of related work order#(b)(4) install date: (b)(6) 2008 defective part number: there were no defective parts work order notes: o subject / reported: wash tower is leaking o problem description: wash tower is leaking o cause: clogged filter assembly o work performed: unclogged filter assembly o solution: unclogged filter assembly o parts replaced: there were no defective parts ¿ returned sample analysis: there were no defective parts.Sample return was not requested.No parts were replaced.¿ manufacturing device history record (dhr) review: review of the dhr for serial number: (b)(6) and pn650686 was reviewed.The instrument met all the manufacturing specifications prior to release.¿ risk analysis: o risk management file part #100245ra, revision 03 was reviewed.O hazard(s) identified? yes no hazard id: 3.1.29 hazard: environment biohazard cause: filter/components in fluid path get clogged harmful effects: exposure to biohazard residual severity: 5 residual probability: 1 residual risk index: 5.¿ root cause: based on the investigation result and fse¿s report the root cause was a clogged/plugged filter assembly.¿ conclusion: based on the investigation results and the fse¿s report the complaint was confirmed for wash tower leaking.No one was harmed or injured, and no medical diagnosis was performed due to any incorrect results.There was no impact to the patient health or safety.
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Event Description
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It was reported that while using the bd facs¿ sample prep assistant that the wash tower is leaking the following information was provided by the initial reporter: the wash tower is leaking.
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Search Alerts/Recalls
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