TRUWAVE DISPOSABLE PRESSURE TRANSDUCER

Description of Event or Problem

AS REPORTED, DURING USE WITH A PATIENT IN THE INTENSIVE CARE AND CONTINUOUS MONITORING UNIT, THE PRESSURE TUBING SUDDENLY DISCONNECTED, SINCE THE STOPCOCK'S LUER GOT UNSCREWED. THE PATIENT'S SHEET WAS FOUND BLOOD-STAINED BY THE NURSE. THE DEVICE WAS REPLACED WITH A NEW ONE TO RESOLVE THE PROBLEM. AS PER CUSTOMER'S OPINION, THERE WAS POTENTIAL RISK OF AIR EMBOLISM, HEMORRHAGE AND INFECTION. THERE WAS NO ALLEGATION OF PATIENT INJURY. THE DEVICE WAS AVAILABLE FOR EVALUATION; HOWEVER, IT HAS NOT BEEN RECEIVED YET.

Additional Manufacturer Narrative

THE PRODUCT IS EXPECTED TO BE RETURNED FOR ANALYSIS; HOWEVER, IT HAS NOT YET BEEN RECEIVED. UPON THE RETURN OF THE PRODUCT A SUPPLEMENTAL REPORT WILL BE SENT WITH THE INVESTIGATION RESULTS. 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 PART OF THIS MONTHLY REVIEW.

Description of Event or Problem

AS REPORTED, DURING USE WITH A PEDIATRIC PATIENT IN THE INTENSIVE CARE AND CONTINUOUS MONITORING UNIT, THE PRESSURE TUBING OF THIS PRESSURE MONITORING SET SUDDENLY DISCONNECTED, SINCE THE STOPCOCK'S LUER GOT UNSCREWED. PATIENT'S SHEET WAS FOUND BLOOD-STAINED BY THE NURSE, WITH AN ESTIMATED BLOOD LOSS OF APPROXIMATELY 4-10 ML. NO FURTHER PATIENT INTERVENTION WAS NEEDED. THE DEVICE WAS REPLACED WITH A NEW ONE TO RESOLVE THE PROBLEM. AS PER CUSTOMER'S OPINION, THERE WAS POTENTIAL RISK OF AIR EMBOLISM, HEMORRHAGE AND INFECTION.

Additional Manufacturer Narrative

AS PER FURTHER INFORMATION RECEIVED UPDATED SECTION B5: ESTIMATED BLOOD LOSS WAS BETWEEN 4 ML AND 10 ML. NO ADDITIONAL INTERVENTION WAS NEEDED. THE DEVICE WAS RECEIVED FOR EVALUATION THE REPORT OF "STOPCOCK LUER GOT UNSCREWED" WAS NOT ABLE TO BE CONFIRMED. ALL CONNECTIONS APPEARED TIGHT AS RECEIVED. NO VISIBLE INCONSISTENCY WAS OBSERVED FROM THE KIT DURING VISUAL EXAMINATION. NO LEAKAGE WAS OBSERVED FROM THE KIT DURING LEAK TEST. NO CONNECTIONS GOT LOOSE OR DETACHED DURING EVALUATION. ALL MALE AND FEMALE LUERS OF DPT HOUSING, STOPCOCKS AND TUBING CONNECTORS DIMENSIONALLY PASSED ISO STANDARDS. THE LOT NUMBER FOR THIS DEVICE WAS NOT SUPPLIED; THEREFORE, FURTHER REVIEW OF THE RELATED MANUFACTURING RECORDS COULD NOT BE PERFORMED. THERE ARE MANUFACTURING CONTROLS ARE IN PLACE CONCERNING THE REPORTED MALFUNCTION.