BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MODEL 3000 - 30ML VOLUME, HIG

    MDR report key: 7561937 · Received June 1, 2018

    Report

    Report Number
    1226348-2018-00610
    Event Type
    Injury
    Date Received
    June 1, 2018
    Date of Event
    April 3, 2018
    Report Date
    May 3, 2018
    Manufacturer
    CODMAN AND SHURTLEFF, INC
    Product Code
    LKK
    UDI-DI
    10886704043591
    PMA / PMN Number
    P890055
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WI, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 0

    PRODUCT COMPLAINT # (B)(4). THIS FINAL MDR WILL BE THE ONLY REPORT SUBMITTED FOR MFR REPORT #1226348-2018-00610. CONCLUSION: BASED ON THE INFORMATION, THE EVENT COULD NOT BE CONFIRMED. THE PRODUCT WAS NOT RETURNED FOR ANALYSIS AND A DEVICE HISTORY RECORD REVIEW CANNOT BE COMPLETED BECAUSE THE LOT FOR THE PRODUCT IS UNKNOWN. THERE IS NO CURRENT SAFETY SIGNAL IDENTIFIED RELATED TO THE REPORTED EVENT BASED ON REVIEW OF COMPLAINT HISTORY FOR THE DEVICE. SINCE THERE WAS NO EVIDENCE TO SUGGEST THE EVENT WAS RELATED TO A MANUFACTURING OR DESIGN ISSUE, NO CORRECTIVE ACTIONS WILL BE TAKEN AT THIS TIME.

    Additional Manufacturer Narrative · 1

    THIS INITIAL MDR WILL BE THE ONLY REPORT SUBMITTED FOR MFR REPORT #1226348-2018-00610. THE LOT/SERIAL NUMBER IS UNKNOWN, THEREFORE THE MANUFACTURE AND EXPIRATION DATES ARE UNKNOWN. THE PRODUCT WILL NOT BE RETURNED FOR ANALYSIS AND ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Description of Event or Problem · 1

    IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THAT A CODMAN 3000 (AP03000H/UNK) WAS IMPLANTED IN A PATIENT ON (B)(6) 2018 AND THE PATIENT PRESENTED WITH A HEMATOMA AT THE IMPLANT SITE (LUQ) ON (B)(6) 2018. THE HEMATOMA WAS LOCATED IN THE PUMP POCKET AND DEVELOPED SUDDENLY AT 3 WEEKS POST-OP. PRIOR IMAGES WITHOUT ANY FLUID IN THAT LOCATION WERE NOTED AT 2 WEEKS POST-OP. THE PHYSICIAN WAS CONCERNED THAT THE HEMATOMA MAY HAVE COME FROM AN ISSUE AT THE CATHETER INSERTION SITE, SUCH AS BACKBLEEDING UP THE TUBING FROM THE GDA. THE PATIENT REPORTEDLY HAD SOME COAGULOPATHY AS WELL THAT MAY HAVE CONTRIBUTED. THE HEMATOMA WAS MANAGED BY WASHOUT. THE PUMP WAS NOT BEING USED PRIOR TO THE WASHOUT AND THERE WERE NO DRUGS INSIDE OF IT. FUDR WAS USED WITH THE PUMP AFTER THE WASHOUT. THERE WAS NO REPORTED INJURY TO THE PATIENT AS A RESULT OF THIS EVENT. REPORTEDLY, THE PATIENT HAS A HISTORY OF COLON CANCER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    402644 MODEL 3000 - 30ML VOLUME, HIG PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK CODMAN AND SHURTLEFF, INC 10886704043591

    Patients

    Seq Age Sex Outcome Treatment
    1 42 YR