BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    NASAL ALAR SPO2 SENSOR

    MDR report key: 7004095 · Received November 6, 2017

    Report

    Report Number
    3010150334-2017-00001
    Event Type
    Malfunction
    Date Received
    November 6, 2017
    Date of Event
    September 18, 2017
    Report Date
    November 6, 2017
    Manufacturer
    XHALE ASSURANCE, INC
    Product Code
    DQA
    PMA / PMN Number
    K171423
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MS, US
    Reporter Occupation
    RESPIRATORY THERAPIST

    Narratives

    Additional Manufacturer Narrative · 1

    THIS REPORT IS ASSOCIATED WITH REPORT NUMBER: MW5072594. DURING THE MANUFACTURING PROCESS, THE SILICONE CUSHIONS ARE ATTACHED TO THE SENSOR BODY BY TWO SEPARATE MECHANISMS: FRICTION FIT OF THE ASSOCIATED PARTS AND A CYANOACRYLATE ADHESIVE THAT IS DESIGNED FOR DIFFICULT-TO-BOND TO MATERIALS. EITHER OF THESE MECHANISMS ALONE SHOULD BE SUFFICIENT TO PREVENT THE SILICONE CUSHION FROM SEPARATING FROM THE SENSOR BODY. A REDUNDANT APPROACH WAS TAKEN TO MINIMIZE THE ASSOCIATED RISK. THE SENSOR IN QUESTION WAS DISCARDED AT THE HOSPITAL WITHOUT THE CLINICAL TEAM NOTING AN ISSUE HAD OCCURRED. THIS PREVENTED THE COMPLETION AN INVESTIGATION ON THE PRODUCT AND THE ABILITY TO DETERMINE AN ACCURATE ROOT CAUSE OF THE CUSHION SEPARATION. THE DEFECT IS DETECTABLE AS THE SILICONE CUSHIONS ARE WHITE AND THE SENSOR BODY IS BLACK. ALL INDICATIONS ARE THAT THE OVAL-SHAPED INNER CUSHION REMAINED CONNECTED AND THE CLINICIAN SHOULD HAVE NOTICED THAT THE OUTER T-SHAPED SILICONE CUSHION HAD BECOME SEPARATED FROM THE SENSOR BODY. THIS IS THE FIRST OCCURRENCE OF SUCH AN EVENT WITH OVER (B)(4) SENSORS SOLD WITH 2 CUSHIONS PER SENSOR (COMPRISES (B)(4) SILICONE CUSHIONS). SENSORS FROM 4 SEPARATE MANUFACTURING LOTS WERE EVALUATED AND DETERMINED TO HAVE SUFFICIENT ADHESIVE ON BOTH SILICONE CUSHIONS, MINIMIZING THE POSSIBILITY OF A SYSTEMATIC ISSUE. IT IS NOT POSSIBLE TO DETERMINE WHAT CAUSED THIS PARTICULAR CUSHION TO BECOME SEPARATED FROM THE SENSOR BODY. ADDITIONALLY, EVEN AFTER THE CUSHION TRAVELED TO THE ORAL CAVITY, GRAVITY WOULD NORMALLY CAUSE THE CUSHION TO ENTER THE ESOPHAGUS AND THE STOMACH CAUSING NO HARM OR EVENT. THE PRODUCT'S RISK MANAGEMENT FILE WAS REVIEWED AND THE ASSOCIATED HAZARD AND PROBABILITY HAD BEEN APPROPRIATELY IDENTIFIED AND EVALUATED. THERE WERE NO CHANGES TO THE SEVERITY OR PROBABILITY OF OCCURRENCE. THEREFORE, THE RISKS ASSOCIATED WITH THE PRODUCT REMAIN ACCEPTABLE. THE ALAR SENSOR PROVIDES A CLEAR BENEFIT TO MONITORING PATIENT OXYGEN SATURATION AND HEART RATE, ESPECIALLY FOR THOSE PATIENTS WITH POOR BLOOD PERFUSION TO THEIR EXTREMITIES. CUSTOMER COMPLAINTS WILL BE MONITORED FOR ANY RELATED EVENTS THAT MAY SUGGEST THIS IS ANYTHING MORE THAN AN ISOLATED INCIDENT.

    Description of Event or Problem · 1

    THIS REPORT IS ASSOCIATED WITH REPORT NUMBER: MW5072594. XHALE ASSURANCE WAS NOTIFIED OF THIS EVENT ON (B)(6) 2017 AND DETERMINE IT SHOULD BE REPORTED TO THE FDA ON (B)(4) 2017. DUE TO THIS BEING THE FIRST EVENT IN THE MDR PROCESS, XHALE ASSURANCE DID NOT HAVE AN ACTIVE WEBTRADER ACCOUNT. THE PROCESS TO OBTAIN A PRODUCTION ACCOUNT WAS INITIATED ON OCT 19TH, 2017 AND THE PRODUCTION ACCOUNT WAS ACTIVATED ON NOV 6TH, 2017. THIS REPORT WAS SUBMITTED AS SOON AS THE PRODUCTION ACCOUNT WAS ACTIVE. THE PATIENT ASSOCIATE WITH THIS EVENT WAS NOT HARMED. THE EVENT DID REQUIRE A CLINICAL PROFESSIONAL TO RETRIEVE THE SILICONE CUSHION. XHALE ASSURANCE REQUESTED A SITE VISIT BY ONE OF OUR CLINICAL PROFESSIONALS TO INVESTIGATE; HOWEVER, THE FACILITY DETERMINED IT WOULD NOT HAVE BEEN BENEFICIAL GIVEN THE LITTLE INFORMATION AVAILABLE ON THE CASE. THE T-SHAPE SILICONE CUSHION OF THE NASAL ALAR SPO2 SENSOR, THAT RESTS AGAINST THE OUTSIDE OF THE NASAL ALA, WAS FOUND IN THE AIRWAY OF A PATIENT. THE DISCOVERY WAS MADE DURING AN UNRELATED TRACHEOTOMY PROCEDURE. THE SILICONE CUSHION HAD BEEN AT THIS LOCATION FOR SOME UNDETERMINED TIME AFTER IT BECAME SEPARATED FROM THE SENSOR BODY. THE FACILITY STATED THAT THE PATIENT HAD AN ORAL ENDOTRACHEAL TUBE IN PLACE FOR APPROXIMATELY 20 DAYS PRIOR TO THE DISCOVERY AND THE CLINICAL TEAM DID NOT NOTE THAT ANY OF THE ALAR SENSORS THAT HAD BEEN UTILIZED WITH THIS PATIENT HAD A SEPARATED CUSHION. THIS LAPSE IN TIME MADE IT DIFFICULT FOR THE CAREGIVER TO OBTAIN AND PROVIDE A CLEAR UNDERSTANDING OF THE EVENT. ADDITIONALLY, THE ASSOCIATED SENSOR WAS DISCARDED AT THE HOSPITAL WITHOUT THE OPPORTUNITY TO COMPLETE AN INVESTIGATION OF THE PRODUCT. GIVEN THE LIMITED INFORMATION AVAILABLE FOR THIS EVENT, THE FOLLOWING SERIES OF EVENTS WOULD LIKELY HAVE HAD TO OCCUR. THE SILICONE CUSHION HAD TO BECOME DISLODGED FROM THE SENSOR BODY (EVEN THOUGH IT IS ATTACHED UNDER A FRICTION FIT AND THEN SECURED WITH ADHESIVE). THE CUSHION WOULD HAVE EITHER HAD TO TRAVEL FROM THE NOSTRIL TO THE BACK OF THE THROAT THROUGH THE NASAL SINUS IF INHALED THROUGH THE NOSE, WHICH IS UNLIKELY AS THE SUBJECT CUSHION IS THE OUTER CUSHION POSITIONED OUTSIDE THE NOSTRIL, OR EXTERNALLY THROUGH AN OPEN MOUTH. THE SILICONE CUSHION MUST GO UNNOTICED BY THE PATIENT AND THE CAREGIVER WHILE IN THE NASAL SINUS OR MOUTH. THE CUSHION MUST PASS ANTERIOR TO THE ESOPHAGUS AND INTO THE TRACHEA WITHOUT THE PATIENT BEING ABLE TO COUGH OR OTHERWISE EJECT THE CUSHION FROM THE AIRWAY. ADDITIONALLY, EVEN AFTER THE CUSHION TRAVELED TO THE ORAL CAVITY, GRAVITY WOULD NORMALLY CAUSE THE CUSHION TO ENTER THE ESOPHAGUS AND THE STOMACH CAUSING NO HARM OR EVENT. THE SILICONE CUSHION IS MANUFACTURED FROM MEDICAL GRADE SILICONE DESIGNED FOR MEDICAL AND PHARMACEUTICAL APPLICATION INCLUDING IMPLANTATION FOR < 30 DAYS. HOWEVER, OUR TEAM HAS TAKEN THE APPROACH THAT A SILICONE CUSHION IN THE AIRWAY PROVIDES AN OPPORTUNITY FOR INFECTION AND/OR REDUCTION IN BREATHING CAPACITY HAD IT NOT BEEN REMOVED BY THE CLINICAL TEAM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    784653 NASAL ALAR SPO2 SENSOR OXIMETER, PROBE DQA XHALE ASSURANCE, INC

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention