BEUDAMED
    FDA Adverse Event Death Summary report: N

    UNKNOWN INTERVENTIONAL SPECIALTIES PRODUCT

    MDR report key: 2995440 · Received March 8, 2013

    Report

    Report Number
    9680904-2013-00007
    Event Type
    Death
    Date Received
    March 8, 2013
    Date of Event
    March 22, 2011
    Report Date
    February 6, 2013
    Manufacturer
    CAREFUSION
    Product Code
    DWM
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). INVESTIGATION SUMMARY:A SAMPLE WAS NOT PROVIDED FOR EVALUATION.REVIEW OF THE PRODUCTION RECORDS FOR THE LOT(S) INVOLVED COULD NOT BE PERFORMED AS LOT NUMBER INFORMATION WAS NOT AVAILABLE. IT WAS DETERMINED THAT NEITHER CAREFUSION MANUFACTURING PERSONNEL NOR CAREFUSION'S APPLICABLE MANUFACTURING, INSPECTION, OR PACKAGING PROCESSES ARE RELATED TO THE ISSUE REPORTED, AS THE ALCOHOL PREP PAD IS A PRODUCT THAT CAREFUSION RECEIVED FROM A SUPPLIER (TRIAD GROUP). THE ALCOHOL PREP PAD IS JUST INCLUDED IN THE FINAL PACKAGE BY CAREFUSION AND IS NOT ALTERED OR MANIPULATED IN ANY WAY BY THE CAREFUSION MANUFACTURING FACILITY THAT COULD RESULT IN OR CAUSE THE CONTAMINATION ISSUE REPORTED.THE MOST PROBABLE ROOT CAUSE COULD NOT BE DETERMINED AS A SAMPLE WAS NOT RECEIVED FOR EVALUATION; HOWEVER, TRIAD GROUP VOLUNTARILY RECALLED ALL LOTS OF ITS STERILE AND NON-STERILE ALCOHOL PREP PAD PRODUCTS. AS AN EFFORT TO OBTAIN A ROOT CAUSE AND PROPER ACTION PLAN FROM THE SUPPLIER, A FORMAL INVESTIGATION WAS REQUESTED TO TRIAD ON FEBRUARY 2, 2011, WHEN THE RECALL WAS IN PROGRESS. IN ADDITION, CAREFUSION HAS QUALIFIED A NEW STERILE ALCOHOL PREP PAD FROM ANOTHER SUPPLIER THROUGH A FORMAL DESIGN CONTROL PROCESS AND IS CURRENTLY USING THIS NEW PRODUCT.

    Description of Event or Problem · 1

    CUSTOMER ADVOCACY RECEIVED A LITIGATION DOCUMENT INVOLVING THIS PATIENT FROM (B)(4). THE FOLLOWING IS A SUMMARY OF THE DOCUMENT AS IT PERTAINS TO THE PLEURX KITS THE PATIENT WAS USING: PLAINTIFF (B)(6), BOTH AS AN INDIVIDUAL AND ALSO AS THE SUCCESSOR IN INTEREST FOR (B)(6), DECEASED WIFE OF PLAINTIFF, ASSERTS THE CLAIM THAT ON OR ABOUT (B)(6) 2010, PATIENT (B)(6) UNDERWENT A PROCEDURE AT (B)(6) HOSPITAL IN (B)(6) WHEREIN A CATHETER WAS PLACED IN HER CHEST WALL. THERE WERE NO COMPLICATIONS AND THE PATIENT WAS LATER DISCHARGED HOME. FOLLOWING THE SURGERY, (B)(6) PROVIDED THE PATIENT AND HER SPOUSE WITH PLEURX KITS, OR SIMILAR KITS. TRAINING ON THE USE OF THE PLEURX KITS WAS PROVIDED TO THE PATIENT AND SPOUSE BY (B)(6). THE TRAINING INCLUDED HOW AND WHEN TO USE THE ALCOHOL PREP PRODUCTS (MANUFACTURED BY TRIAD GROUP, INC) INCLUDED IN THE KITS TO CLEAN AND PREPARE FOR DRAINAGE OF THE CATHETER AND CATHETER ENTRY SITE. THE ALCOHOL PREP PRODUCTS PROVIDED TO THE PATIENT WERE CONTAMINATED WITH BACILLUS CEREUS AND CAUSED THE PATIENT A SERIOUS INFECTION. THIS INFECTION, ULTIMATELY LED TO MULTIPLE ORGAN FAILURE AND THE PATIENT DIED ON (B)(6) 2011. THE PATIENT'S SPOUSE ALLEGES THAT THEY RECEIVED NO NOTICE THAT THE ALCOHOL PREP PRODUCTS WERE RECALLED. NO SPECIFIC PRODUCT CODE OR LOT INFORMATION WAS PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98550 UNKNOWN INTERVENTIONAL SPECIALTIES PRODUCT DWM CAREFUSION UNK-IS

    Patients

    Seq Age Sex Outcome Treatment
    1 50 YR Death