BEUDAMED
    FDA Adverse Event Injury Summary report: N

    MODEL 3000 - 30ML VOLUME, HIG

    MDR report key: 7718085 · Received July 25, 2018

    Report

    Report Number
    1226348-2018-00660
    Event Type
    Injury
    Date Received
    July 25, 2018
    Date of Event
    June 16, 2018
    Report Date
    June 18, 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
    PA, US
    Reporter Occupation
    OTHER HEALTH CARE PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THIS INITIAL MDR WILL BE THE ONLY REPORT SUBMITTED FOR MFR REPORT #1226348-2018-00660. THE PRODUCT IS AVAILABLE FOR EVALUATION AND TESTING, HOWEVER THE ANALYSIS HAS NOT BEEN COMPLETED. ADDITIONAL INFORMATION WILL BE SUBMITTED WITHIN 30 DAYS OF RECEIPT.

    Additional Manufacturer Narrative · 1

    PRODUCT COMPLAINT # (B)(4). CONCLUSION: CODMAN 3000 PUMP, SERIAL NUMBER (B)(4), WAS RECEIVED FOR EVALUATION; HOWEVER, THERE WERE NO ALLEGED DEVICE MALFUNCTIONS. THEREFORE, A DEVICE INVESTIGATION IS NOT REQUIRED. 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.

    Description of Event or Problem · 1

    IT WAS REPORTED BY A HEALTHCARE PROFESSIONAL THAT A CODMAN 3000 PUMP (AP03000H/15501) THAT HAD BEEN IMPLANTED ON (B)(6) 2017, WAS EXPLANTED FROM A PATIENT DUE TO INFECTION. THE PATIENT PRESENTED WITH REDNESS, PAIN, SWELLING, AND WARMTH AROUND THE PUMP ON (B)(6) 2018 AND IT WAS NOTED THAT THE PATIENT HAD AN INFECTED PUMP POCKET. THE INFECTION WAS LOCATED ON THE PATIENT¿S SKIN AND SOFT TISSUES. IN ADDITION TO EXPLANTING THE PUMP, THE PATIENT¿S INFECTION WAS TREATED WITH IV ABX AND PO ABX. THE INFECTION RESOLVED ON (B)(6) 2018. THE PATIENT WAS NOT IMPLANTED WITH A NEW PUMP AND THE PATIENT¿S STATUS IS CURRENTLY IMPROVING AS THE CANCER IS IN REMISSION AND HEPATIC INSUFFICIENCY. GLYCEROL WAS IN THE PUMP AT THE TIME OF EXPLANT. REPORTEDLY, THE PATIENT HAS A MEDICAL HISTORY OF CHOLANGIO CA, OBESITY, HEPATIC INSUFFICIENCY, DEPRESSION, ANXIETY, AND CDIF INFECTION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    562488 MODEL 3000 - 30ML VOLUME, HIG PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK CODMAN AND SHURTLEFF, INC 10886704043591

    Patients

    Seq Age Sex Outcome Treatment
    1 54 YR Required Intervention