TRUWAVE DISPOSABLE PRESSURE TRANSDUCER

Additional Manufacturer Narrative

AS PER FURTHER INFORMATION RECEIVED UPDATED SECTIONS B1, H1 AND SECTION B5 : THE PATIENT WAS TREATED WITH ANTIDIURETICS (LASILIX) AND HE IS OKAY. ADDED INFORMATION TO SECTION H6 (CLINICAL CODE), UPDATED SECTION H6 (IMPACT CODE) AD H6 (DEVICE CODE).

Description of Event or Problem

AS REPORTED, SEVERAL TIMES DURING 7 DAYS OF USE IN A PREMATURE BABY, THIS DISPOSABLE PRESSURE TRANSDUCER GOT DEPRESSURIZED CAUSING BACK FLOW AND A FLAT BLOOD PRESSURE CURVE. THE SYSTEM WAS FLUSHED AND PRESSURIZED EVERY TIME THE PROBLEM OCCURRED A PART FROM THE DAILY SYSTEM CHECKS. THE SYSTEM PRESSURE HAD TO BE ADJUSTED SEVERAL TIMES A DAY, WHICH IS UNUSUAL. ONE OF THE TIMES, THE SALINE BAG WAS NOTICED EMPTY. THIS MEANS THAT THE CHILD SHOULD HAVE RECEIVED 336 ML OVER 7 DAYS AND THAT THE ENTIRE 1-LITER BAG HAS BEEN CONSUMED. THE ENTIRE SYSTEM WAS REPLACED. THE CONSEQUENCES FOR THE PATIENT WERE ELECTROLYTE IMBALANCES, FAILURE TO INSERT A CENTRAL VENOUS CATHETER DUE TO EXCESSIVE LYMPHATIC FLUID, RESPIRATORY DIFFICULTIES WITH DELAYED EXTUBATING AND GAINED UP TO 310G BY DAY 4. THE PATIENT WAS TREATED WITH ANTIDIURETICS (LASILIX) AND HE IS OKAY.

Additional Manufacturer Narrative

THE DEVICE OF THE REPORTED COMPLAINT WAS RECEIVED BY OUR PRODUCT EVALUATION LABORATORY FOR A FULL EXAMINATION. REPORT OF FLOW RATE ISSUE WAS UNABLE TO BE CONFIRMED. RETURNED PRESSURE MONITORING KIT WAS PRIMED AND FLUSHED WITHOUT ANY INDICATION OF OCCLUSION OR FLOW RESTRICTION. NO LEAKAGE WAS DETECTED FROM THE KIT DURING LEAK TEST. FLOW RATE THROUGH DPT WAS 2.4 ML/HOUR WHICH WAS WITHIN SPECIFICATION. SPECIFICATION WAS 2-4 ML/HOUR PER IFU. NO VISIBLE DAMAGE WAS OBSERVED FROM THE KIT. BASED ON FURTHER ENGINEERING INVESTIGATION, A DEFINITE ROOT CAUSE WAS UNABLE TO BE ESTABLISHED SINCE NO DEFECT WAS FOUND ON THE RETURNED DEVICE. THE MANUFACTURING RECORDS WERE REVIEWED AND THERE IS NO INDICATION OF A RELATED NONCONFORMANCE; ALL PROCESS PARAMETERS WERE MET, AND INSPECTIONS PASSED SUCCESSFULLY. BASED ON THE AVAILABLE INFORMATION, NO ACTION WAS REQUIRED AT THIS TIME; HOWEVER, ALL EVENTS WILL CONTINUE TO BE REVIEWED AND MONITORED.

Additional Manufacturer Narrative

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. 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.

Description of Event or Problem

AS REPORTED, SEVERAL TIMES DURING 7 DAYS OF USE IN A PREMATURE BABY, THIS DISPOSABLE PRESSURE TRANSDUCER GOT DEPRESSURIZED CAUSING BACK FLOW AND A FLAT BLOOD PRESSURE CURVE. THE SYSTEM WAS FLUSHED AND PRESSURIZED EVERY TIME THE PROBLEM OCCURRED APART FROM THE DAILY SYSTEM CHECKS. THE SYSTEM PRESSURE HAD TO BE ADJUSTED SEVERAL TIMES A DAY, WHICH IS UNUSUAL. ONE OF THE TIMES, THE SALINE BAG WAS NOTICED EMPTY. THIS MEANS THAT THE CHILD SHOULD HAVE RECEIVED 336 ML OVER 7 DAYS AND THAT THE ENTIRE 1-LITER BAG HAS BEEN CONSUMED. THE ENTIRE SYSTEM WAS REPLACED. THE CONSEQUENCES FOR THE PATIENT WERE ELECTROLYTE IMBALANCES, FAILURE TO INSERT A CENTRAL VENOUS CATHETER DUE TO EXCESSIVE LYMPHATIC FLUID, RESPIRATORY DIFFICULTIES WITH DELAYED EXTUBATING AND GAINED UP TO 310G BY DAY 4. THERE WAS NO ALLEGATION OF PATIENT INJURY.