BEUDAMED
    FDA Adverse Event Death Summary report: N

    MULTI-SITE ATTACHMENT RING FOR MATURE/INTACT SKIN

    MDR report key: 13083569 · Received December 24, 2021

    Report

    Report Number
    3004149774-2021-00001
    Event Type
    Death
    Date Received
    December 24, 2021
    Date of Event
    October 26, 2021
    Report Date
    December 8, 2021
    Manufacturer
    SENTEC AG
    Product Code
    LKD
    UDI-DI
    07640121880797
    PMA / PMN Number
    K151329
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    RISK MANAGER
    Health Professional
    N

    Narratives

    Additional Manufacturer Narrative · 0

    ALLEGED SERIOUS INJURY ON EXTREMELY PREMATURE PATIENT WITH TRANSLUCENT AND FRAGILE SKIN. THE MARE-MI WAS USED PREVIOUSLY ON THE SITE AT WHICH THE ADVERSE EVENT OCCURRED. INCONCLUSIVE WHICH ROLE THE MARE-MI HAD IN THE INJURY. SENTEC OFFERS ANOTHER PRODUCT SPECIFICALLY DESIGNED FOR USE ON SENSITIVE AND FRAGILE SKIN (MULTISITE ATTACHMENT RING FOR FRAGILE/SENSITIVE SKIN MARE-SF) THAT WOULD HAVE BEEN MORE APPROPRIATE FOR USE. THE INSTITUTION SWITCHED TO USE OF THE MARE-SF AFTER THE EVENT. THE INSTITUTIONAL PRACTICE IS TO KEEP THE ATTACHMENT RINGS ON THE SAME SITE AS LONG AS POSSIBLE TO MINIMIZE POTENTIAL SKIN TRAUMA FROM RING REMOVAL AND ATTACHMENT. PER OUR IFU - "DO NOT USE SENSOR ATTACHMENT ACCESSORIES OR CONTACT GEL ON INJURED SKIN OR ON PATIENTS WHO EXHIBIT ALLERGIC REACTIONS TO THESE DISPOSABLES" ALSO, "WE RECOMMEND LEAVING THE SITE FREE OF ADHESIVE FOR UP TO 8 TO 12 HOURS" AND SITE INSPECTION AND CLEANING OF SKIN" AFTER MEASUREMENT. THE SEVERITY OF APPARENT INJURY MAY HAVE BEEN PREVENTED WITH PROPER INSPECTION AND TREATMENT. THE PATIENT CONDITION (AND ENVIRONMENTAL CONDITIONS) MAY HAVE PLAYED A ROLE IN THE FURTHER DEVELOPMENT OF THE INJURY. AFTER REVIEW OF ALL INFORMATION AVAILABLE, INCLUDING PICTURES OF THE INJURY SITE, SENTEC BELIEVES THAT THE DEVICE FUNCTIONED PROPERLY BUT BECAUSE OF THE TIME ON PATIENT, PATIENT SKIN CONDITION AND THE (POTENTIAL) EFFECTS OF ENVIRONMENTAL CONDITIONS SUCH AS ELEVATED TEMPERATURE, REMOVAL OF THE ADHESIVE RING IRRITATED AND/OR INJURED THE SKIN THAT MAY OR MAY NOT HAVE BEEN TREATED IMMEDIATELY UNTIL CONSULTATION FOR WOUND ASSESSMENT MORE THAN 2 DAYS LATER.

    Description of Event or Problem · 0

    ON (B)(6) 2021, NURSING OBSERVED A NEONATE WITH INFECTED WOUND, WHICH DEVELOPED A DEEP ABDOMINAL WALL NECROSIS ON THE RIGHT ABDOMEN. SENTEC WAS INFORMED 10-NOV-2021, RECEIVED INCOMPLETE INFORMATION UNTIL 29-NOV-2021. SENTEC WAS NOTIFIED OF DEATH 06-DEC-2021. NEONATE WITH INFECTED WOUND, WHICH DEVELOPED A DEEP ABDOMINAL WALL NECROSIS ON THE RIGHT ABDOMEN. THE NEONATE WAS BORN AT THE GESTATIONAL AGE OF (B)(6) AND WAS (B)(6) OLD AT THE TIME OF THE EVENT. THE PATIENT WAS EXTREMELY PREMATURE AND AT HIGH RISK. THE PATIENT HAD VERY TRANSLUCENT AND FRAGILE SKIN. FROM THE DESCRIPTION OF THE EVENT AND THE ATTACHED PICTURES PROVIDED TO THE MANUFACTURER, IT IS NOT CONCLUSIVE AS TO WHAT CAUSED THE WOUND. THE FOLLOWING INFORMATION WAS PROVIDED BY THE CUSTOMER: THE PATIENT WAS UNDER HIGH-HUMIDITY AND BEING HYDRATED ON (B)(6) 2021. THE MEASUREMENT SITE ON THE RIGHT ABDOMEN WAS USED FOR THE LAST TIME ON (B)(6) 2021. AFTER (B)(6) 2021, THE SENSOR WAS PLACED ON OTHER BODY LOCATIONS ON THE LEFT ABDOMEN AND THIGHS. NURSES DID NOT DOCUMENT ANY CONCERN ON THAT DATE AND SKIN COLOR WAS CHARTED AS NORMAL ON THE PRIOR DAY. NO PRESSURE OR ADDITIONAL TAPE WAS USED. THE CARE TEAM HAD CHANGED THEIR CARE FOR THE PATIENT AND STARTED TO "DRY-OUT" THE PATIENT. CLINICAL TEAM DECIDED TO KEEP THE MARE-MI ON AT THE SAME SITE FOR AS LONG AS POSSIBLE, SO AS NOT TO DAMAGE THE SKIN BY TEARING OFF THE RING FREQUENTLY. CLINICAL TEAM ALSO NOTED A "BURN" FROM PULSE OXIMETER PUT ON LEFT TOE (NOT A SENTEC DEVICE). NURSING NOTED CIRCULAR BREAKDOWN ON (B)(6) 2021, AND PLACED CONSULT FOR WOUND ASSESSMENT THE SAME DAY. THE INSTITUTION TRANSFERRED THE PATIENT FOR HIGHER LEVEL CARE TO ANOTHER FACILITY. THEY WERE INFORMED THAT THE PATIENT BECAME INFECTED WITH A RARE FUNGAL INFECTION AND BECAME SEPTIC. THE PATIENT WAS SUBSEQUENTLY PLACED ON COMFORT CARE AND EXPIRED ON (B)(6) 2021.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1982269 MULTI-SITE ATTACHMENT RING FOR MATURE/INTACT SKIN MULTI-SITE ATTACHMENT RING EASY FOR MATURE/INTACT SKIN LKD SENTEC AG MARE-MI 07640121880797

    Patients

    Seq Age Sex Outcome Treatment
    1 2 WK Female Death| R| H