SUNMED LLC

Additional Manufacturer Narrative

THE AIR LEAKING DURING INTUBATION DELAYED THERAPY TO PATIENT WOULD CAUSE A DISRUPTION IN RESUSCITATION EFFORTS AND PATIENT OXYGEN SATURATION DECREASED. THE COMPLAINT OF "AIR LEAKING DURING INTUBATION, NOT DELIVERING THE PATIENT O2." REGARDING PART NUMBER AF5140MB/LOT 428861 WAS CONFIRMED. RETURNED PRODUCT WAS INVESTIGATED. VISUAL INSPECTION IDENTIFIED A LOOSE DIAPHRAGM VALVE WITHIN THE BAG BODY AND IT WAS CONCLUDED THAT THE DIAPHRAGM VALVE WAS NOT ASSEMBLED CORRECTLY AND BECAME LOOSE PRIOR TO END-USE. A RISK ASSESSMENT WAS PERFORMED, AND THE ULTIMATE RISK WAS DETERMINED TO BE HIGH WHICH DOES REQUIRE REPORTING TO THE CAPA REVIEW BOARD; THE COMPLAINT WAS SUBMITTED TO CARB AND THEY DECIDED TO OPEN A CAPA (CAPA-00513) FOR THIS ISSUE. THERE HAVE BEEN TWO (2) OTHER CONFIRMED COMPLAINTS REGARDING PART NUMBER AF5140MB FOR THE SAME ISSUE WITHIN THE 24 MONTHS PRECEDING THE REPORTING OF THIS ISSUE. A MEMO, CONTAINING THE COMPLAINT INVESTIGATION, WAS SENT TO THE CUSTOMER. COMPLAINTS WILL CONTINUE TO BE MONITORED FOR POSSIBLE TRENDS.

Description of Event or Problem

AIR LEAKING DURING INTUBATION, NOT DELIVERING THE PATIENT O2.  OCCURRED DURING PATIENT USE, POSSIBLE DELAY IN TREATMENT.

Additional Manufacturer Narrative

THE AIR LEAKING DURING INTUBATION DELAYED THERAPY TO PATIENT WOULD CAUSE A DISRUPTION IN RESUSCITATION EFFORTS AND PATIENT OXYGEN SATURATION DECREASED.

Description of Event or Problem

AIR LEAKING DURING INTUBATION, NOT DELIVERING THE PATIENT O2.  OCCURRED DURING PATIENT USE, POSSIBLE DELAY IN TREATMENT.