BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMEPUMP C-SERIES: 270 ML, 5 ML/HR

    MDR report key: 4217272 · Received May 23, 2014

    Report

    Report Number
    2026095-2014-00068
    Event Type
    Malfunction
    Date Received
    May 23, 2014
    Date of Event
    May 2, 2014
    Report Date
    May 5, 2014
    Manufacturer
    I-FLOW LLC
    Product Code
    MEB
    PMA / PMN Number
    K052117
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: THE DEVICE WAS RECEIVED FOR ANALYSIS. THE LOT NUMBER WAS NOT AVAILABLE THEREFORE, WE COULD NOT REVIEW THE DEVICE HISTORY RECORD. RESULTS: RESULTS WILL BE PROVIDED ONCE THE EVAL AND INVESTIGATION HAVE BEEN COMPLETED. CONCLUSION: OUR INVESTIGATION AND EVAL IS CURRENTLY IN PROGRESS, ONCE COMPLETED, A F/U REPORT WILL BE SUBMITTED. INFO FROM THIS INCIDENT WILL BE INCLUDED IN OUR PRODUCT COMPLAINT AND MDR TREND REPORTING SYSTEM. ADD'L INVESTIGATION MAY ARISE FROM ONGOING ANALYSIS, TREND INFO, OR OTHER ANALYSIS AS APPROPRIATE.

    Description of Event or Problem · 1

    FILL VOLUME: 230 ML. FLOW RATE: 5 ML/HR. PROCEDURE: CHEMOTHERAPY. CATHPLACE: IV PORT. A PT REPORTED THAT AN ECLIPSE PUMP WAS REPLACED ON (B)(6) 2014 AT ABOUT 06:30 PM. THE ECLIPSE PUMP SHOULD HAVE FINISHED INFUSION IN THE LATE AFTERNOON AT ABOUT 04:30 PM ON 05/02/2014. HOWEVER, THE PT REPORTED THAT WHEN HE AWOKE ON (B)(6) 2014 AT APPROX 05:00 AM THE ECLIPSE WAS EMPTY.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    309308 HOMEPUMP C-SERIES: 270 ML, 5 ML/HR ELASTOMERIC PUP MEB I-FLOW LLC C270050 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 82 YR DRUG/DILUENT: (B)(4), NS