BEUDAMED
    FDA Adverse Event Injury Summary report: N

    HOMEPUMP ECLIPSE: 100 ML, 100 ML/HR

    MDR report key: 2950337 · Received February 6, 2013

    Report

    Report Number
    2026095-2013-00013
    Event Type
    Injury
    Date Received
    February 6, 2013
    Date of Event
    June 11, 2012
    Report Date
    January 8, 2013
    Manufacturer
    I-FLOW, LLC
    Product Code
    MEB
    PMA / PMN Number
    K052117
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: NO SAMPLE WILL BE REC'D FOR EVAL AND INVESTIGATION. RESULTS: A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS CONDUCTED FOR THE LOT NUMBER PROVIDED, AND THE DEVICE PASSED ALL MFG SPECIFICATIONS PRIOR TO RELEASE. CONCLUSIONS: THE PHARMACIST EXPLAINED THEIR INFUSION PROCESS, THE PHARMACY TECH FILLED THE PUMP, THE PHARMACIST CHECK THE PUMP, AND THE NURSE CHECKED THE PUMP BEFORE ATTACHING IT TO THE PT. THROUGH ALL THESE STEPS, ALL PERSONNEL INVOLVED DID NOT NOTICE THE WRONG PUMP WAS USED. AT THIS TIME I-FLOW IS TRYING TO OBTAIN ADD'L INFO TO FURTHER INVESTIGATE THIS COMPLAINT. A F/U REPORT WILL BE FILED WHEN THE INVESTIGATION HAS BEEN COMPLETED.

    Description of Event or Problem · 1

    DRUG/DILUENT: 5 FU, FILL VOLUME: 100 ML, FLOW RATE: 100 ML/HR, PROCEDURE: CHEMOTHERAPY, CATHPLACE: PICC CATHETER. ON (B)(6) 2012, A PT REC'D A HOMEPUMP ECLIPSE (100ML BY 100ML/HR). THE ORDER WAS WRITTEN FOR A HOMEPUMP (100ML BY 2ML/HR). THE PHARMACIST STATED THAT THE CORRECT PUMP WAS ORDERED, THE PT REC'D THE WRONG PUMP. THE PT RETURNED TO THE INFUSION CENTER AFTER 2 HRS AND SAID THAT HIS PUMP WAS EMPTY. HYDRATION WITH MULTIVITAMINS WAS STARTED IMMEDIATELY. SIX DAYS LATER PT RETURNED WITH MOUTH SORES. HE WAS THEN GIVEN MUCOSITIS SUSPENSION AND HYDRATED AGAIN. SORES WENT AWAY AFTER A COUPLE OF DAYS. PT WAS REPORTED TO BE FINE. THE PT WAS NOT HOSPITALIZED DUE TO THE INCIDENT. (ADD'L INFO REC'D: (B)(6) 2013) PHARMACY MANGER REPORTED THAT THE PT PASSED AWAY ABOUT (B)(6) WEEKS AFTER THE INCIDENT (EXACT DATE UNK). THE DATE WAS NOT RELATED TO THE PUMP OR INFUSION, BUT THE PT'S DISEASE PROCESS- CANCER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    49861 HOMEPUMP ECLIPSE: 100 ML, 100 ML/HR ELASTOMERIC PUMP MEB I-FLOW, LLC E101000 0200623847

    Patients

    Seq Age Sex Outcome Treatment
    1 60 YR Other