Catalog Number 4540040-02 |
Device Problems
Degraded (1153); Loose or Intermittent Connection (1371); Component Missing (2306); Contamination /Decontamination Problem (2895); Device Contaminated During Manufacture or Shipping (2969)
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Patient Problem
No Clinical Signs, Symptoms or Conditions (4582)
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Event Type
malfunction
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Manufacturer Narrative
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This report has been identified as b.Braun medical, inc.Internal report (b)(4): event 3.The complaint is still under investigation.A follow-up report will be provided, as soon as investigation has been completed.
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Event Description
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As reported by user facility: event 3."i have some easypump defects to report from throughout august that are summarized below, samples are available for all pumps.2 with orange particle in the patient connector.1 with orange particle in the patient connector.
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Manufacturer Narrative
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This report has been identified as b.Braun medical internal report number (b)(4).Event 3: 82 samples were returned, with foreign particles in the fluid and non-fluid path.After a visual inspection, the complaints were confirmed.This was deemed to be a failure in the production process.We will maintain this report for further references and continue to monitor other reports for similar occurrences.If any additional pertinent information becomes available, a follow up will be submitted.
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Manufacturer Narrative
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This report has been identified as b.Braun medical, inc.Internal report (b)(4): event 3 82 samples were returned, with foreign particles in the fluid and non-fluid path.After a visual inspection, the complaints were confirmed.This was deemed to be a failure in the production process.Please note that we are unsure if the follow-ups were originally submitted or received on 08jun2022 and we are resubmitting out of an abundance of caution.We will maintain this report for further references and continue to monitor other reports for similar occurrences.If any additional pertinent information becomes available, a follow up will be submitted.
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Search Alerts/Recalls
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