BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    I-FLOW

    MDR report key: 2982685 · Received February 22, 2013

    Report

    Report Number
    MW5029145
    Event Type
    Malfunction
    Date Received
    February 22, 2013
    Date of Event
    February 13, 2013
    Report Date
    February 22, 2013
    Manufacturer
    BRAUN
    Product Code
    FRN
    Product Problem
    Yes
    Report Source
    Voluntary report
    Reporter Location
    ME, US
    Reporter Occupation
    OTHER CAREGIVERS

    Narratives

    Description of Event or Problem · 1

    PT PRESENTED TO ACC EARLIER THIS AM REPORTING THAT HOME INFUSION PUMP "NOT WORKING". UPON INSPECTION, OPP FULL, TAUTE AND ALL 3 CLAMPS ON LINE UNCLAMPED, AND FLOW RESTRICTOR AREA OF TUBING TAPED SECURELY TO SOFT TISSUE OF CHEST. LINE FLUSHED WELL WITH NS WITH GOOD BLOOD RETURN PRESENT. DR (B)(6) INFORMED. PER PHARMACY, DIAMETER OF OPP SAME AS "FULL" MODEL PUMP. NEW 5 FU HOME INFUSION PUMP DISPENSED FROM PHARMACY AND STARTED TO PORT. EXPLANATION TO PT; VERBALIZED UNDERSTANDING. INSTRUCTED PT TO MONITOR PUMP FOR 'DEFLATION' OVERNIGHT AND THAT IF IN AM APPEARS TO NOT BE EMPTYING, TO RETURN TO ACC.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    78229 I-FLOW HOME INFUSION PUMP FRN BRAUN C270050 0200641852

    Patients

    Seq Age Sex Outcome Treatment
    1 85 YR