Nellcor Puritan Bennett Sublingual PCO2 Monitor B' cepacia

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Nellcor Puritan Bennett Sublingual PCO2 Monitor
B. cepacia

• Joanna Weitershausen
• Food and Drug Administration
• Center for Devices and Radiological Health
• Office of Compliance

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Device Description

• The probe is placed under the tongue and the
  device is intended to monitor sublingual PCO2.
• The device is shipped non-sterile in a saline
  solution to preserve sensor integrity.

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Case Events

• Non-significant risk study
• Cluster of Burkholderia cepacia colonization
• No MDRs received
• CDC and Health Department involvement
• CapnoProbe suspected as causing infections
• Initial notification to the public

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Testing for B. cepacia
Electron Micrograph of Burkholderia cepacia.
Credit CDC.

• Culture unopened devices
• Testing
• Manufacturer
• Health Department

B. cepacia expressing CF mucous-binding Credit
Richard Goldstein and J Bacteriol
19951771039-52.
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Manufacturer DH Results
Dendrogram for pulsed-field gel electrophoresis
patterns of Burkholderia cepacia isolates
analyzed by Joey Stringer at the Texas Dept. of
Health Laboratory
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FDA Actions

• Manufacturer voluntary recall
• Press releases
• FDA Press release
• Manufacturers press release
• MMWR - CDC
• Health Hazard Evaluation (HHE)
• Class I recall
• MDRs

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Timeline Recap

• Aug 16 Hospital contacts mfr mfr starts
  testing
• Aug 18 CDC contacts FDA
• Aug 19 CDC post information on website
• Aug 20 Texas HD starts testing
• Aug 24 Mfr identifies multiple types of
  bacteria, initiates device recall
• Aug 25 Texas DNA match
• Aug 26, 27 Press releases
• Aug 27 FDA HHE, classifies recall

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