TRUWAVE, VAMP PLUS

Additional Manufacturer Narrative

ADDITIONAL FDA PRODUCT CODES INCLUDE: KRA- CATHETER, CONTINUOUS FLUSH. ONE VAMP ADULT SYSTEM WAS RETURNED FOR EVALUATION. THE CUSTOMER EPORT OF DEFECTIVE PRODUCT WAS CONFIRMED. AS RECEIVED, THE PRESSURE TUBING WAS FOUND COMPLETELY DETACHED FROM VAMP RESERVOIR BOND JOINT. INDICATIONS OF WHAT APPEARED TO BE BONDING MATERIAL WERE EVIDENT ON TUBING BOND SURFACE AREA. TUBING OD WAS MEASURED TO BE 0.1415 INCHES NEAR THE POINT OF DETACHMENT, WAS WITHIN SPECIFICATION. DRY BLOOD WAS VISIBLE INSIDE INSIDE THE TUBING. NO OTHER VISIBLE DAMAGE OR INCONSISTENCY WAS FOUND TO THE RETURNED VAMP SYSTEM. A SUPPLEMENTAL REPORT WILL BE FORTHCOMING WHEN THE ENGINEERING EVALUATION IS COMPLETED. 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.

Description of Event or Problem

IT WAS REPORTED THAT DURING USE OF THE PRESSURE MONITORING SET THE BLOOD DRAWS APPEARED TO BE DILUTED. THERE WAS NO PATIENT INJURY.