BEUDAMED
    FDA Adverse Event Death Summary report: N

    KIT,PLEURX DRAINAGE 10/CS

    MDR report key: 2324817 · Received November 4, 2011

    Report

    Report Number
    9680904-2011-00023
    Event Type
    Death
    Date Received
    November 4, 2011
    Date of Event
    July 1, 2011
    Report Date
    July 11, 2011
    Manufacturer
    CAREFUSION
    Product Code
    DWM
    PMA / PMN Number
    K971753
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PATIENT FAMILY MEMBER OR FRIEND

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS MDR WAS PREVIOUSLY SUBMITTED ON (B)(4) 2011 AND RECEIVED BY THE FDA WITHIN THE REQUIRED 30 DAY REPORTING TIME FRAME BEARING THE REGISTRATION NUMBER OF CARDINAL HEALTH IN ERROR DUE TO A REPORTING SOFTWARE DISCREPANCY (REPORT # 1423537-2011-00057). CAREFUSION HAS DISCUSSED WITH AND BEEN ADVISED BY (B)(4) OF THE (B)(4) ON (B)(4), 2011, TO RESUBMIT THE MDR BEARING CAREFUSION'S REGISTRATION NUMBER AND TO INCLUDE THIS VERBIAGE WITHIN THE REPORT, AS WELL AS WITHIN CAREFUSION'S COMPLAINT MANAGEMENT SOFTWARE. INVESTIGATION SUMMARY: A SAMPLE WAS NOT AVAILABLE FOR FURTHER EVALUATION. THEREFORE, FURTHER ANALYSIS COULD NOT BE PERFORMED. THE ALCOHOL PREP PAD IS PURCHASED AS A FINISHED PRODUCT FROM THE TRIAD GROUP (LEGAL MANUFACTURER); THEREFORE, THERE IS NO INTERNAL MANIPULATION IN THE PLANT THAT COULD RESULT OR PROVOKE THE REPORTED CONDITION. A PROBABLE ROOT CAUSE COULD NOT BE DETERMINED SINCE A SAMPLE WAS NOT AVAILABLE FOR FURTHER ANALYSIS. HOWEVER, THIS SITUATION IS CURRENTLY UNDER INVESTIGATION BY THE TRIAD GROUP. AS A PRECAUTIONARY MEASURE, THE TRIAD GROUP HAS VOLUNTARILY RECALLED ALL OF THEIR ALCOHOL PREP PADS. A FORMAL SUPPLIER CORRECTIVE ACTION NOTICE WAS INITIATED ON (B)(4) 2011 IN RESPONSE TO THIS ISSUE. IN ADDITION, CAREFUSION HAS NOTIFIED THE TRIAD GROUP OF THIS COMPLAINT IN ORDER TO PROPERLY CAPTURE IN THEIR POST MARKET SURVEILLANCE SYSTEM. CAREFUSION HAS QUALIFIED A NEW STERILE ALCOHOL PREP PAD FROM COVIDIEN/KENDALL THROUGH A FORMAL DESIGN CONTROL PROCESS AND IS CURRENTLY USING THIS NEW PRODUCT.

    Description of Event or Problem · 1

    THE FOLLOWING INFORMATION WAS RECEIVED FROM CAREFUSION'S LEGAL DEPARTMENT: (B)(6), INDIVIDUALLY AND AS ADMINISTRATOR OF THE ESTATE OF (B)(4), FILED A LAWSUIT AGAINST CAREFUSION IN (B)(4).  (B)(6) ALLEGES THAT AN ALCOHOL PREP PAD, MANUFACTURED BY TRIAD GROUP, INC. ("TRIAD") AND INCLUDED IN A CAREFUSION BRANDED PLEURX DRAINAGE KIT, WAS CONTAMINATED WITH THE BACILLIUS CEREUS BACTERIA; AND ITS USE LED TO (B)(6) DEATH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 KIT,PLEURX DRAINAGE 10/CS 500ML DRAINAGE KIT DWM CAREFUSION 50-7500

    Patients

    Seq Age Sex Outcome Treatment
    1 Death