SUCTION REGULATOR

Additional Manufacturer Narrative

THE SUBJECT DEVICE CONSISTS OF A BASE VACUUM REGULATOR (SRQ-2000-1), WHICH IS PURCHASED BY WESTERN FROM (B)(4). THE DEVICE IS SUPPLIED TO WESTERN WITHOUT AN INLET CONNECTION. WESTERN ATTACHES VARIOUS INLET CONNECTION FITTINGS (E.G., HANDTIGHT NUT AND NIPPLE COMBINATION) BASED UPON THE PARTICULAR INLET CONFIGURATION SPECIFIED BY THE CUSTOMER. FOLLOWING ATTACHMENT OF THE INLET FITTINGS, WESTERN PERFORMS A BASIC FUNCTIONAL TEST OF THE FINAL ASSEMBLY PRIOR TO ITS RELEASE. INFORMATION PROVIDED BY THE SUPPLIER INDICATES THE BASE VACUUM REGULATOR (SRQ-2000-1) WAS SHIPPED TO WESTERN ON 3/29/2005. THE INLET CONNECTION FITTINGS WERE THEN ATTACHED BY WESTERN TO COMPLETE THE FINAL ASSEMBLY (SRQ2004) ON 4/28/2005. THE SUBJECT DEVICE WAS APPROXIMATELY 10.3 YEARS OLD AT THE TIME OF THE INCIDENT. UPON RETURN OF THE SUBJECT DEVICE TO WESTERN, PERFORMANCE TESTING WAS CONDUCTED BY WESTERN ENGINEERING, WHICH CONFIRMED THAT THE BASE VACUUM REGULATOR (SRQ-2000-1) DID NOT FUNCTION PROPERLY. AS THE BASE VACUUM REGULATOR IS NOT MANUFACTURED BY WESTERN, NO FURTHER ANALYSIS IS PLANNED.

Description of Event or Problem

AS INITIALLY REPORTED TO WESTERN, "SERIAL # (B)(4). OUT OF WARRANTY. RT TECH WROTE, WHEN SUCTIONING PATIENT, THE PRESSURE GO ALL THE WAY TO MAX EVEN THOUGH I SET IT AT 100 PSI. THAT CAUSED THE TRACH TRAUMA AND BLEEDING. REPLACED WITH ANOTHER SUCTION REGULATOR." FOLLOW-UP INQUIRY WITH THE FACILITY'S RT DIRECTOR, THE REPORT WAS CONFIRMED AND ADDITIONAL INFORMATION OBTAINED. THE INCIDENT INVOLVED A CHRONIC PATIENT THAT HAD A TRACHEOSTOMY AND THE DEVICE WAS BEING USED FOR ROUTINE SUCTIONING. A ROUTINE, PRE-USE CHECK OF THE DEVICE WAS CONDUCTED, WHICH INVOLVED TURNING THE DEVICE ON, CHECKING ITS OPERATION BY THE GAUGE INDICATOR, AND MAKING SURE DEVICE IS SET CORRECTLY. THE RT REPORTED THAT WHEN SUCTIONING THE PATIENT, THE VACUUM WENT ALL THE WAY UP TO MAX EVEN THOUGH IT WAS SET AT 100 MMHG. THE RT REPLACED THE SUBJECT REGULATOR WITH ANOTHER REGULATOR. FOLLOWING THIS INCIDENT, THE PATIENT PRESENTED SOME MINOR TRACHEAL BLEEDING. DURING PATIENT FOLLOW-UP THE NEXT DAY, IT WAS REPORTED THAT BLEEDING HAD SUBSIDED ON ITS OWN, NO TREATMENT WAS REQUIRED. THE INCIDENT WAS CONSIDERED A MINOR INJURY, NOT LIFE-THREATENING. IT DID NOT RESULT IN PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE AND DID NOT NECESSITATE MEDICAL OR SURGICAL INTERVENTION TO PRECLUDE PERMANENT IMPAIRMENT OF A BODY FUNCTION OR PERMANENT DAMAGE TO A BODY STRUCTURE. THE SUBJECT DEVICE WAS FORWARDED TO FACILITY'S BIOMED DEPARTMENT FOR EVALUATION. BIOMED REPORTED THAT WHEN THE DEVICE GETS A CLOG, THE PRESSURE SPIKES UP REAL FAST, BUT IS SUPPOSED TO DROP BACK DOWN RIGHT AWAY AND NOT STAY AT FULL VACUUM. HOWEVER, THE SUBJECT DEVICE STAYED UP AT FULL VACUUM, AND THEREFORE DID NOT FUNCTION PROPERLY.