TRUWAVE, VAMP JR.

Description of Event or Problem

IT WAS REPORTED THAT DURING USE OF THE PRESSURE MONITORING SET THE TEAM NOTICED THAT THE LINE STOPPED READING. UPON CHECKING THE LINE THE TEAM DISCOVERED BUBBLES IN THE LINE AND ATTEMPTED TO CLEAR THEM BUT KEPT PULLING AIR AND COULD NOT IDENTIFY WHERE THE AIR WAS COMING FROM. THEY FOUND THAT THE AIR WAS IN THE SYRINGE CONNECTED TO THE LINE TO TAKE A BLOOD SAMPLE. THEY DID LOOK AT THE FLUIDS HANDING AND THERE WERE WAS NOT ANY AIR IN THE BAG OR THE LINE. THIS WAS USED IN CONJUNCTION WITH THE ARGYLE UMBILICAL VESSEL CATHETER 3.5 FRENCH. THERE WAS NO PATIENT INJURY.

Additional Manufacturer Narrative

ADDITIONAL FDA PRODUCT CODES INCLUDE: KRA - CATHETER, CONTINUOUS FLUSH. THE DEVICE EVALUATION IS ANTICIPATED. HOWEVER, THE COMPLAINT CANNOT BE CONFIRMED WITHOUT THE COMPLETION OF A PRODUCT EVALUATION. A SUPPLEMENTAL REPORT WILL BE FORTHCOMING WHEN THE INVESTIGATION IS COMPLETED. THE DEVICE HISTORY RECORD REVIEW WAS NOT BEEN COMPLETED AS THE LOT NUMBER WAS NOT PROVIDED. COMPLAINT HISTORIES FOR ALL REPORTED EVENTS ARE REVIEWED AGAINST TRENDING CONTROL LIMITS ON A MONTHLY BASIS AND ANY EXCURSIONS ABOVE THE CONTROL LIMITS ARE ASSESSED AND DOCUMENTED AS A PART OF THE MONTHLY REVIEW.

Additional Manufacturer Narrative

THE DEVICE WAS NOT RETURNED FOR EVALUATION. WITHOUT RETURN OF THE UNIT, IT IS NOT POSSIBLE TO DETERMINE IF SOME DAMAGE OR DEFECT EXISTED ON THE UNIT THAT COULD HAVE CONTRIBUTED TO THE EVENT. A DEVICE HISTORY RECORD REVIEW WAS UNABLE TO BE COMPLETED AS THE LOT NUMBER IS UNKNOWN. AN ENGINEERING EVALUATION WAS INITIATED TO ASSESS FOR ANY MANUFACTURING RELATED PROCESSES WHICH COULD BE CORRELATED TO THE COMPLAINT. AS NO DEVICE WAS RETURNED, A PRODUCT NON-CONFORMANCE OR DEVICE FAILURE COULD NOT BE CONFIRMED AND NO ROOT CAUSE COULD BE DETERMINED. AS PART OF THE MANUFACTURING PROCESS 100% OF THE UNITS UNDERGO VISUAL INSPECTION, MANUFACTURING CONTINUOUS MONITORING SAMPLING, AND A QA SAMPLING INSPECTION AS WELL AS A LEAK AND FLOW TEST.