BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    HOMEPUMP C-SERIES 270 ML, 1 ML/HR

    MDR report key: 4213134 · Received August 4, 2014

    Report

    Report Number
    2026095-2014-00132
    Event Type
    Malfunction
    Date Received
    August 4, 2014
    Date of Event
    May 15, 2014
    Report Date
    July 9, 2014
    Manufacturer
    I-FLOW LLC
    Product Code
    MEB
    PMA / PMN Number
    K052117
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    EI
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: THE DEVICE WAS REPORTED TO BE RETURNING FOR ANALYSIS, AT THE TIME IT IS PENDING RECEIPT. A REVIEW OF THE DEVICE HISTORY RECORD (DHR) WAS CONDUCTED FOR THE REPORTED LOT NUMBER. RESULTS: PER THE DHR THERE WERE NO REWORKS, SPECIAL CONDITIONS, OR RELATED NONCONFORMANCE REPORTS (NCRS) FOR THIS LOT. THE LOT MET SPECIFICATIONS PRIOR TO RELEASE. CONCLUSION: AT THIS TIME I-FLOW IS PENDING THE RETURN OF THE DEVICE FOR AN EVALUATION. THE INVESTIGATION IS ONGOING, ONCE COMPLETED A FOLLOW-UP REPORT WILL BE SUBMITTED. INFORMATION FROM THIS INCIDENT WILL BE INCLUDED IN OUR 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

    FILL VOLUME: 200 ML, FLOW RATE: 1 ML/HR, PROCEDURE: CHEMOTHERAPY, CATHPLACE: UNK-ANP. A DISTRIBUTOR REPORTED THAT AN ECLIPSE PUMP INFUSED TOO FAST. AFTER THE SIXTH DAY OF INFUSION THE PUMP WAS REPORTED TO BE EMPTY AND APPEARED TO HAVE FINISHED INFUSION AT LEAST 24 HOURS EARLY. THE PUMP WAS FILLED ON (B)(6) 2014 AT 10:05-10:15 INFUSION WAS STARTED ON (B)(6) 2014 (TIME NOT PROVIDED) AND INFUSION ENDED ON (B)(6) 2014 (TIME NOT PROVIDED). IT WAS EXPECTED THAT THERAPY WOULD LAST SEVEN DAYS. NO ADVERSE EVENT, INJURY OR MEDICAL INTERVENTION NEEDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    455652 HOMEPUMP C-SERIES 270 ML, 1 ML/HR ELASTOMERIC PUMP MEB I-FLOW LLC C270010 0200477108

    Patients

    Seq Age Sex Outcome Treatment
    1 DRUG: 3075MG 5-FLUOROURACIL DILUTED IN 200ML OF| 0.9% NAC1