TRUWAVE, VAMP

Description of Event or Problem

IT WAS REPORTED THAT DURING USE ON PATIENT, THIS PRESSURE MONITORING KIT ONLY DISPLAYED A VALUE OF 300 AS AN INVASIVE BLOOD PRESSURE. THIS PRESSURE MONITORING KIT WAS ABLE TO ZERO AND COULD BE USED AT FIRST. ONE OR TWO HOURS AFTER THE OPERATION STARTED, THE DOCTOR NOTICED THAT THE VALUE OF INVASIVE BLOOD PRESSURE WAS ABNORMAL SINCE IT WAS DISPLAYED AS 300 AND INSTRUCTED TO REPLACE IT. THE CUSTOMER TRIED TO PERFORM SEVERAL TROUBLE SHOOTINGS, AND WHEN THE DEVICE WAS REPLACED, THE PROBLEM WAS SOLVED. PATIENT MONITOR WAS MU-671R MADE BY NIHON KOHDEN. THIS KIT WAS TO BE USED FOR AN EMERGENCY NEUROSURGICAL OPERATION. NO FURTHER INFORMATION WAS AVAILABLE. THERE WAS NO ALLEGATION OF PATIENT INJURY.

Additional Manufacturer Narrative

THE DEVICE EVALUATION IS ANTICIPATED. A SUPPLEMENTAL REPORT WILL BE FORTHCOMING WHEN THE INVESTIGATION IS COMPLETED. THE DEVICE HISTORY RECORD REVIEW WAS NOT 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. D2B. ADDITIONAL DEVICE PRODUCT CODE: KRA- CATHETER, CONTINUOUS FLUSH G4. ADDITIONAL PMA/510K: K173586, K896819.

Additional Manufacturer Narrative

ONE PRESSURE MONITORING KIT WAS RETURNED FOR EVALUATION. THE CUSTOMER REPORT OF PRESSURE ISSUE WAS NOT ABLE TO BE CONFIRMED. DPT ZEROED AND SENSED PRESSURE ACCURATELY ON PRESSURE MONITOR. PRESSURE DID NOT SHOW ANY DRIFT DURING OUTPUT DRIFT TESTING AND MET SPECIFICATION. ELECTRICAL AND TESTING SHOWED THAT BOTH INPUT IMPEDANCE 2,180 OHMS AND OUTPUT IMPEDANCE 314 OHMS WERE WITHIN SPECIFICATIONS. NO LEAKAGE OR OCCLUSION WAS DETECTED FROM THE UNIT DURING PRESSURE TEST. NO VISIBLE DAMAGE WAS OBSERVED FROM THE UNIT. AN ENGINEERING EVALUATION WAS INITIATED TO ASSESS FOR ANY MANUFACTURING RELATED PROCESSES WHICH COULD BE CORRELATED TO THE COMPLAINT. THE REPORTED ISSUE WAS UNABLE TO BE CONFIRMED THROUGH THE PRODUCT EVALUATION. THEREFORE, NO PRODUCT NOR PROCESS MALFUNCTION WAS IDENTIFIED IN THIS COMPLAINT. THERE ARE MANUFACTURING CONTROLS TO AVOID POTENTIAL CAUSES RELATED TO INACCURATE VALUES WHICH INCLUDE VISUAL INSPECTION, LEAK TEST, FLOW TEST, AND ELECTRICAL TESTING OF 100 PERCENT OF DEVICES IN ADDITION TO QUALITY SAMPLING INSPECTIONS. A DEVICE HISTORY RECORD REVIEW WAS COMPLETED AND DOCUMENTED THAT DEVICE MET ALL SPECIFICATIONS UPON DISTRIBUTION. 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.