BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMEPUMP C-SERIES: 270 ML, 2ML/HR

    MDR report key: 3784147 · Received April 22, 2014

    Report

    Report Number
    2026095-2014-00049
    Event Type
    Injury
    Date Received
    April 22, 2014
    Date of Event
    February 10, 2014
    Report Date
    March 24, 2014
    Manufacturer
    I-FLOW CORP., LLC
    Product Code
    MEB
    PMA / PMN Number
    K052117
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FL, US
    Reporter Occupation
    RISK MANAGER

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: THE DEVICE WAS RETURNED FOR AN EVALUATION AND INVESTIGATION, A VISUAL INSPECTION WAS PERFORMED ON THE RETURNED UNIT AND TESTING IS CURRENTLY IN PROGRESS. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) IS IN PROGRESS FOR THE REPORTED LOT NUMBER. RESULTS: AT THIS TIME, THE RESULTS ARE PENDING THE COMPLETION OF THE EVALUATION AND INVESTIGATION WHICH IS CURRENTLY IN PROGRESS. CONCLUSIONS: THE DEVICE WAS RECEIVED FOR EVALUATION AND INVESTIGATION. TESTING IS CURRENTLY BEING PERFORMED ON THE RETURNED UNIT. A FOLLOW-UP REPORT WILL BE FILED WHEN THE INVESTIGATION HAS BEEN COMPLETED. INFORMATION FROM THIS INCIDENT WILL BE INCLUDED IN OUR PRODUCT COMPLAINT AND MDR TREND REPORTING SYSTEM. ADDITIONAL INVESTIGATION MAY ARISE FROM ONGOING ANALYSIS, TREND INFORMATION, OR OTHER ANALYSIS AS APPROPRIATE.

    Description of Event or Problem · 1

    DRUG/DILUENT: 5 FU, 2000MG/0.9%NACL 243 ML. FILL VOLUME: 243 ML. FLOW RATE: 2ML/HR. PROCEDURE: CHEMOTHERAPY. CATHPLACE: CHEST PORT. A MAUDE REPORT (REF# (B)(4)) WAS RECEIVED, DESCRIBING A (B)(6) OLD FEMALE PT WHO EXPERIENCED MUCOSITIS, STOMATITIS, DEHYDRATION, MALNUTRITION AND WAS HOSPITALIZED WHILE USING THE HOMEPUMP. ADDITIONAL INFO PROVIDED: PT RECEIVED 5FU VIA ELASTOMERIC PUMP. MEDICATION INFUSED OVER 4 DAYS RATHER THAN 5 DAYS. NO SIGN OF OVER LEAKAGE. ON (B)(6), THE INFUSION STARTED AND THE PT EXPERIENCED SYMPTOMS 4 DAYS AFTER. SHE ALSO FINISHED RADIATION TREATMENT FOR HER COLON CANCER ON (B)(6). THE PUMP WAS REPORTED TO BE EMPTY ON (B)(6). ON (B)(6), SHE WAS HOSPITALIZED FROM MUCOSITIS, STOMATITIS, DEHYDRATION, MALNUTRITION. PT RECEIVED TREATMENT INCLUDING IV FLUIDS AND ANTEMETIC, SYMPTOMS DISSIPATED AFTER TREATMENT AND SHE WAS DISCHARGED ON (B)(6). IT WAS REPORTED THAT THE PT'S CURRENT CONDITION IS FINE. DATE/TIME INFUSION START: (B)(6) 2014 AT 12:44PM. DATE/TIME INFUSION STOP: (B)(6) 2014 AT 11:17AM. DATE/ TIME INCIDENT/DEFECT NOTICED: (B)(6) 2014 AT 11:17AM. PUMP WAS REPORTED TO BE EMPTY AT THE TIME OF DISCONNECT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    244312 HOMEPUMP C-SERIES: 270 ML, 2ML/HR ELASTOMERIC PUMP MEB I-FLOW CORP., LLC C270020 0201022130

    Patients

    Seq Age Sex Outcome Treatment
    1 59 YR Hospitalization| R HUBER PLUS 20G CATHETER