Company: Integra LifeSciences Corp..
Date of Enforcement Report:2/5/2014
Class lI:
PRODUCT
ntegra Camino Advanced Monitor with Waveform Display Model CAM01 Integra Neurosciences, 311 Enterprise Dr Plainsboro, NJ 08536 USA_x000D_ _x000D_ The Camino Advanced Monitor is a compact, portable device for use with Camino 110-4 series of Pressure / Temperature and Pressure Transducer-Tipped Catheters. Pressure and/or Temperature are measured at the Catheter tip, eliminating the need for external transducers, fluid, pressure tubing, and flush devices. The Camino displays intracranial pressure (ICP), intracranial temperature (ICT), and calculates cerebral perfusion pressure (CPP) (CPP = mean arterial pressure – mean intracranial pressure). The Camino provides a continuous display of the ICP waveform, as well as mean ICP, CPP, ICT, or systolic and diastolic waveform values. A continuous record of mean pressure and CPP values over the most recent 24-hour period is stored in memory, and can be displayed on command as a TREND either as the most recent 12 or 24 hour period. Outputs for ICP and ICT are available for use with patient bedside monitors. An isolated analogue output provides a continuous ICP waveform for hard copy documentation or data acquisition. An input to receive mean arterial pressure from a compatible patient bedside monitor is available for use when it is desired to have a CPP reading. The mean arterial pressure cannot be acquired from a non-invasive blood pressure cuff. Although the Camino is intended to be a stand-alone system, it also conveniently connects to hospital bedside monitoring systems. _x000D_ _x000D_ Recall Number Z-0602-2014
REASON
Integra became aware through a complaint from a single non-US customer that if the optional SYS/DIAS mode is used on CAM01 monitor that contains Mod 4 Firmware, the displayed values for the systolic and diastolic intracranial pressure (ICP) are reversed. But, if the CAM01 is used with an auxiliary bedside monitor, the bedside monitor displays these values correctly.
RECALLING FIRM/MANUFACTURER
Integra LifeSciences Corp., Plainsboro, NJ on 11/26/2013. Voluntary: Firm Initiated recall is ongoing.
VOLUME OF PRODUCT IN COMMERCE
275 CAM01 Monitors
DISTRIBUTION
Nationwide and Internationally
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