BEUDAMED
    FDA Adverse Event Injury Summary report: N

    LIBERTY (ITEM # UNK)

    MDR report key: 4193504 · Received October 20, 2014

    Report

    Report Number
    1419937-2014-00791
    Event Type
    Injury
    Date Received
    October 20, 2014
    Date of Event
    September 29, 2014
    Report Date
    October 14, 2014
    Manufacturer
    MEDELA INC.
    Product Code
    OMP
    PMA / PMN Number
    K080357
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    IL, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    ON (B)(6) 2014 (B)(6) CLINICAL SPECIALIST WITH (B)(6) RECOVER CARE WENT TO THE (B)(6) HOSPITAL TO WORK WITH (B)(6). OBSERVATIONS DURING DRESSING CHANGES INCLUDED CLEANSING PERI WOUND AND WOUND BED WITH BACTI STAT AND NOT RINSING OFF. BACTI STAT IS A ANTIMICROBIAL HAND SOAP AND NOT INTENDED FOR USE IN A WOUND AND MAY IMPAIR WOUND HEALING. NOT RINSING OFF OF THE SKIN COULD AFFECT ADHESION OF TRANSPARENT FILM. VIBRA RN WAS ALSO CUTTING THE AVANCE FOAM INTO STRIPS AND PLACING A WOUND. THE IFU INSTRUCTS CLINICIANS TO CUT THE FOAM TO FIT THE SHAPE OF THE WOUND. STRIPS WILL NOT FORM AN INTIMATE CONTACT WITH THE WOUND BED AND AS SUCH THERE MAY BE IN EQUAL DISTRIBUTION OF NPWT TO THE WOUND BED. VIBRA RN WAS ALSO USING THE AVANCE TRANSPARENT FILE TO WINDOW PANE THE WOUND EVEN THOUGH IT WAS CLINICALLY UNNECESSARY AND MAY RESULT IN MACERATION OF THE PERIWOUND SKIN DUE TO DECREASING THE MVTR. ACTION PLAN AGREED UPON BY (B)(6). STOP USING BACTI STAT AND START USING NS IRRIGATION WITH PSI OF 4-15PSI OR SURFACTANT WOUND CLEANSER. CLEANSE THE PERIWOUND SKIN AND PAT DRY. ENSURE THERE IS NO CLEANSER RESIDUAL ON THE SKI. PROTECT THE PERIWOUND SKIN BY USING A SKIN PROTECTANT BARRIER. AVOID USING WINDOW PANE TECHNIQUE UNLESS THERE IS RISK THE FOAM WILL TOUCH THE ERI WOUND SKIN. CUT THE AVANCE FOAM SLIGHTLY SMALLER THAN THE WOUND. CUT TO THE SHAPE OF THE WOUND. DO NOT CUT INTO STRIPS. REVIEW LEVINE WOUND CULTURE TECHNIQUE WITH WOUND TEAM. IMPROPER TECHNIQUE CAN LEAD TO CONTAMINATION OF CULTURE. HOLD AND MOLD THE AVANCE TRANSPARENT FILE AND THEN REMOVE THE SECOND LAYER. FULL TACK ACHIEVED AT 15 MINUTES. (B)(6) RN, SBN, CWOCN (B)(6) 2014. (B)(6) NATIONAL CLINICAL DIRECTOR FOR (B)(6) SPECIALTY HOSPITALS PROVIDED VERBAL AND WRITTEN ANSWERS TO CLINICAL ASSESSMENT QUESTIONS STATED THE PT WAS A MALE ADMITTED FOR CONTINUED PERITONEAL DIALYSIS AND HEALING OF AMPUTATED RIGHT GREAT TOE. ON (B)(6) 2014, HE WAS SWITCHED FROM SAND N NPWT TO A MEDELA, WHERE HE REMAINED UNTIL GOING OUT ACUTE ON 08/08/2014. HE RETURNED 08/08/2014, HE WENT BACK ON TO THE MEDELA (B)(6) 2014 AND REMAINED IN THERAPY UNTIL (B)(6) 2014. WHEN THE RIGHT GREAT TOW WAS CULTURED IT GREW NO ORGANISMS AT FULL CULTURE. ON (B)(6) 2014, THE RIGHT GREAT TOE WAS EVALUATED AND ASSESSED BY DR (B)(6) AND WOUND TEAM, UPON BREAKDOWN OF MEDELA NPWT DRESSING THE WOUND WAS NOTED WITH FOUL ODOR AND PURULENT DRAINAGE. THE WOUND WAS CULTURED AND DEBRIDED. THE WOUND CULTURED; 3 PLUS GRAM POSITIVE COCCI, AND 4 PLUS STAPH AUREUS. THE WOUND WAS CLEANSED WITH NORMAL SALINE AND BACTI STAT SOAP. THE AVANCE TRANSPARENT FILM DRESSINGS HAD TROUBLE MAINTAINING A SEAL. THE DRAPE TEARS EASILY AND OR IS DISPLACED EASILY. THE WOUND HAD A FAIR AMOUNT OF DRAINAGE IN WOUND BED AT TIME OF CHANGE. HE WAS IN A PRIVATE ROOM. NO OTHER WOUND PRODUCTS WERE USED IN THE WOUND AND THE PERI WOUND SKIN WAS CLEANSED WITH BACTI STAT AND CAVILON BARRIER FILM APPLIED. AT THE START OF MEDELA NPWT THE WOUND BED TISSUE TYPE WAS 75 PERCENT GRANULA AND 25 PERCENT CLEAN NON GRANULAR. AT DISCONTINUATION OF MEDELA THE TISSUE TYPE WAS 75 PERCENT NON GRANULAR AND VISUALLY APPEARED TO HAVE A HIGH BIOBURDEN. AT DISCONTINUATION OF MEDELA NPWT THERE WAS PERI WOUND ERYTHEMA, MACERATION AND PURULENT DRAINAGE. THE PT REQUIRED MEDICAL TREATMENT CONSISTING OF ORAL ANTIBIOTICS, DEBRIDEMENT, TOPICAL GENTAMICIN WHICH WAS LATER CHANGED TO BACTROBAN AND OIL EMULSION. THE CURRENT PT STATUS IS DISCHARGED HOME WITH HOME HEALTH. (B)(6) RN, BSN, CWOCN (B)(6) 2014.

    Description of Event or Problem · 1

    THE CUSTOMER REPORTED THAT THE MEDELA INVIA LIBERTY DEVICE MAY HAVE CAUSED OR CONTRIBUTED TO A SERIOUS INJURY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    666805 LIBERTY (ITEM # UNK) OMP MEDELA INC. 087XXX/UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R