BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

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

    MDR report key: 3880363 · Received April 8, 2014

    Report

    Report Number
    2026095-2014-00040
    Event Type
    Malfunction
    Date Received
    April 8, 2014
    Date of Event
    February 19, 2014
    Report Date
    March 11, 2014
    Manufacturer
    I-FLOW, LLC
    Product Code
    MEB
    PMA / PMN Number
    K052117
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CO, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: IT WAS REPORTED THAT THE DEVICE IS NOT AVAILABLE FOR AN EVAL AND INVESTIGATION, THEREFORE NO TESTING METHODS CAN BE PERFORMED. AS A LOT NUMBER WAS NOT PROVIDED A REVIEW OF THE DEVICE HISTORY RECORD (DHR) CANNOT BE CONDUCTED. RESULTS: AS NO DEVICE WAS AVAILABLE FOR AN EVAL, NO METHODS WERE PERFORMED, THEREFORE, RESULTS CANNOT BE OBTAINED. CONCLUSIONS: THE DEVICE WAS DISCARDED BY THE END USER, THEREFORE WE ARE UNABLE TO DETERMINE CAUSE OF INCIDENT. FURTHER INVESTIGATIONS ARE ON-GOING WITH THE REPORTED INFO. IF ADD'L INFO PERTINENT TO THIS EVENT BECOMES AVAILABLE, I-FLOW FILL SUBMIT A F/U REPORT. THE TECH BULLETIN FACTORS AFFECTING FLOW RATE. HOMEPUMP AMBULATORY INFUSION SYSTEM. HOMEPUMP C-SERIES ((B)(4)). PROVIDES FACTORS THAT MAY AFFECT THE FLOW RATE OF THE DEVICE AS PROVIDED BELOW: A VARIETY OF FACTORS SUCH AS FILL VOLUME, TEMPERATURE, PUMP POSITION, AND STORAGE TIMES AFFECT THE FLOW RATE ACCURACY OF ELASTOMETRIC PUMPS. THESE FACTORS MAY RESULT IN AN INCREASE OR DECREASE IN FLOW RATE FROM THE LABELED FLOW RATE AND IMPACT THE DELIVERY TIME. FLOW RATE ACCURACY SPECIFICATION IS BASED ON FILLING THE PUMP TO THE LABELED FILL VOLUME. FILLING THE PUMP LESS THAN THE LABELED FILL VOLUME INCREASES FLOW RATE. FILLING THE PUMP MORE THAN THE LABELED FILL VOLUME DECREASE THE FLOW RATE. 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

    DRUG/DILUENT: 20 MG/ML 5FU IN NAC1. FILL VOLUME: 230 ML. FLOW RATE: 5 ML/HR. PROCEDURE: CHEMOTHERAPY. CATHPLACE: PICC. A FAST FLOW WAS REPORTED. PT REPORTED THAT ECLIPSE INFUSED ENTIRE 230 ML'S BY (5 ML/HR) IN 19 HRS RATHER THAN INTENDED 46 HRS. FLOW REGULATOR WAS TAPED TO PT, HOWEVER, ECLIPSE HAD BEEN UNDER BLANKETS NEXT TO PT. THE PHARMACIST COMPLETED THE I-FLOW REPORT ALSO. WE DO NOT HAVE THE PRODUCT TO RETURN, IT HAD BEEN PLACED IN A CHEMO SHARPS CONTAINER. IT WAS REPORTED THAT NO ADVERSE EVENT OR INJURY OCCURRED. PT'S CURRENT CONDITION WAS REPORTED AS "SIMILAR." INFUSION START: (B)(6) 2014 AT 15:00. INFUSION END: (B)(6) 2014 AT 12:00 PM. ADD'L INFO RECEIVED (B)(4) 2014 (CLARIFICATION OF MODEL AND LOT #): THE LOT NUMBER ORIGINALLY REPORTED WAS INCORRECT AS THE MODEL OF THE DEVICE USED ON THE PT IS A C-SERIES PUMP. AT THIS TIME THE LOT NUMBER OF THE DEVICE USED IS UNK PER THE PHARMACY MANAGER.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    211806 HOMEPUMP C-SERIES: 270 ML, 5 ML/HR ELASTOMETRIC PUMP MEB I-FLOW, LLC C270050 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 65 YR BARD GROSHING CATHETER