BEUDAMED
    FDA Adverse Event Injury Summary report: N

    STATSEAL

    MDR report key: 5072036 · Received September 11, 2015

    Report

    Report Number
    1066421-2015-00001
    Event Type
    Injury
    Date Received
    September 11, 2015
    Date of Event
    August 4, 2015
    Report Date
    August 13, 2015
    Manufacturer
    BIOLIFE, LLC
    Product Code
    FRO
    PMA / PMN Number
    K130324
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    NURSE

    Narratives

    Description of Event or Problem · 1

    ESTIMATED (B)(6). CURRENTLY (B)(6) CORRECTED; (B)(6). BABY EXPERIENCING ABDOMINAL DISTENTION AND APNEA REQUIRING INTUBATION 2 DAYS PRIOR TO TRANSPORT; ABDOMINAL DISTENTION WORSENED WITH A FIXED LOOP IN RUQ NOTED ON KUB WITH BLOOD TINGED OUTPUT.. THEN TRANSFERRED TO CMC FOR SURGICAL EVALUATION. INFANT ADMITTED ON (B)(6) 2015 AND HAD SURGERY WITH SILO PLACED; INFANT TENUOUS POST-OPERATIVELY WITH FLUID SHIFTS AND SIGNIFICANT THIRD SPACING...FEM ARTERIAL LINE (RT) AND CL FEM (LT) PLACED DURING SURGERY FOR MEDS/BLOOD PRODUCTS/IVF/DRIPS, ETC. EVENT: BOTH CENTRAL LINE DRESSING CAME BACK FROM OR UN-OCCLUSIVE -SAQ TEAM NOTIFIED AND PERFORMED DRESSING CHANGES PER PROTOCOL + PLACED STAT SEAL DISC ON BOTH SITES. SAQ TEAM PERFORMED DAILY LINE ROUNDING THEREAFTER. BOTH FEM LINES WERE FOUND TO BE OOZING BLOOD/SEROUS DRAINAGE AT SITES(*DRAINAGE THOUGH TO BE RELATED TO OOZING FROM SILO CONTENTS) SAQ PERFORMED DRESSING CHANGES ON 8/2 +8/3-SKIN INTEGRITY NOTED TO BE OK AT THIS TIME (B)(6) 2015-RIGHT FEM ARTERIAL LINE NOTED TO BE OOZING- SITE LOOKED OK OTHERWISE FROM OUTSIDE OF THE DRESSING CHANGE PERFORMED AND 1.5 WIDE X 1 DEEP WAS IDENTIFIED- WITH BONE EXPOSED NICU MEDICAL TEAM, CNS, WOUND +SURGERY ALL CALLED TO THE BEDSIDE AND DECIDED TO ASSESS THE OTHER FEM LINE- AND AN ADDITIONAL WOUND (SMALLER) NOTED UNDER THE STAT SEAL SURGERY D/S'D BOTH LINES AND PLACED A BROVIAC CVL - TEGADERM ONLY PLACED ON SITE FAMILY NOTIFIED AND UPDATED CURRENT STATUS: INFANT REMAINS TENUOUS AND MEDICAL TEAM IS DISCUSSING REMOVAL OF CARE (FROM UNDERLYING DISEASE PROCESS) WOUNDS ARE HEALING PER WOUND TEAM.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    601478 STATSEAL STATSEAL DISC FRO BIOLIFE, LLC DS014

    Patients

    Seq Age Sex Outcome Treatment
    1 9 MO Hospitalization| O