BEUDAMED
    FDA Adverse Event Death Summary report: N

    INF. SET INSET

    MDR report key: 2780397 · Received October 3, 2012

    Report

    Report Number
    3003442380-2012-00018
    Event Type
    Death
    Date Received
    October 3, 2012
    Date of Event
    July 24, 2011
    Report Date
    October 2, 2012
    Manufacturer
    UNOMEDICAL A/S
    Product Code
    FPA
    PMA / PMN Number
    K032854
    Removal / Correction Number
    NA
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    PA, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    UNOMEDICAL A/S HAS RECEIVED ONE USED DEVICE. TESTS SHOWED THAT THE DEVICE HAD COSMETIC DAMAGES. COSMETIC ERRORS CAUSED BY MATERIALS USED FOR OR PROCESSES IN THE MANUFACTURING OF THE TUBING CAN OCCUR. DAMAGES TO THE TUBING CAN OCCUR DURING SEVERAL STEPS IN MANUFACTURING. TO PREVENT SYSTEMATIC FAILURES DURING MANUFACTURING, UNOMEDICAL USES ONLINE SAMPLING PLANS ACCORDING TO ISO 2859-1. SAMPLE SIZES ARE TESTED AGAINST SPECIFICATIONS. USE OF EXCESSIVE FORCE AND/OR TOOLS OR CONTACT WITH CERTAIN SUBSTANCES SUCH AS DISINFECTANTS OR PERFUMES MAY ALSO CAUSE DAMAGES TO THE TUBING. USED DEVICE: A VISUAL INSPECTION AND A TEST FOR FLOW AND LEAK WERE PERFORMED ON THE RETURNED USED DEVICE. THE TUBING HAD VISUAL DAMAGES. THE FLOW AND LEAK TESTS WERE WITHIN SPECIFICATIONS. UNUSED DEVICES: NO UNUSED DEVICES WERE RETURNED FOR TESTING. REFERENCE SAMPLES: THE RETAINED SAMPLES WERE NOT TESTED. LOT # UNK. (B)(6).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT DIED ON (B)(6) 2011. PRIMARY CAUSE WAS LISTED AS HEART ATTACK ON THE DEATH CERTIFICATE ACCORDING TO FAMILY MEMBER. PATIENT WAS FOUND DEAD AT HOME (B)(6) 2011. THE FAMILY MEMBER REPORTED THAT MEDICS REMOVED THE INFUSION SET FROM BODY. THE FAMILY MEMBER REPORTED THAT THE END OF THE CANNULA LOOKED CURVED, THE TUBING HAD AIR BUBBLES IN IT WITHOUT SIGNS OF LEAKAGE. LAST BG REGISTERED ON METER IS 555 MG/DL ON (B)(6) 2011, REPORTS PATIENT HAD A BG ELEVATION OF 800 MG/DL ON (B)(6) 2011 AND WAS TAKEN TO AN UNKNOWN HOSPITAL. PATIENT'S BG WERE TREATED VIA SYRINGE/LANTUS. IT WAS DETERMINED THAT PATIENT MAY HAVE SUFFERED KIDNEY FAILURE AND A SLIGHT HEART ATTACK AROUND THE TIME OF THE ELEVATED BG. FAMILY MEMBER REPORTED THAT PATIENT WAS NOT EATING WELL AND WAS TRANSFERRED TO A NURSING FACILITY. SHE WAS RELEASED FROM THE FACILITY ON (B)(6) 2011 TO HOME HEALTH CARE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INF. SET INSET INSET FPA UNOMEDICAL A/S 100-181-01 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 67 YR Death