BEUDAMED
    FDA Adverse Event Other Summary report: N

    READYMED ELASTOMERIC INFUSION SYSTEM

    MDR report key: 1366011 · Received January 23, 2009

    Report

    Report Number
    9616066-2009-00030
    Event Type
    Other
    Date Received
    January 23, 2009
    Manufacturer
    CARDINAL HEALTH ALARIS PRODUCTS
    Product Code
    MEB
    PMA / PMN Number
    K913658
    Removal / Correction Number
    NO. PENDING
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B) (4). FILE NUMBERS WITH INVOLVED MODEL NUMBERS: (B) (4) = R250100, (B) (4) = R050050, (B) (4) = R250100, (B) (4) = R250100, (B) (4) = R100100, (B) (4) = R250050, (B) (4) = R250100, (B) (4) = R250167, (B) (4) = R250100, (B) (4) = R250167, (B) (4) = R250167, (B) (4) = R250167, (B) (4) = R250100, (B) (4) = R250167, (B) (4) = R100200, (B) (4) = R250167, (B) (4) = R250167.

    Description of Event or Problem · 1

    DURING A COMPLAINT INVESTIGATION, AN OUT OF SPEC CONDITION FOR FLOW RATE WAS DISCOVERED IN CERTAIN UNITS, WHICH RESULTED IN A VOLUNTARY RECALL OF THE READYMED ELASTOMERIC AMBULATORY INFUSION SYSTEM. THE COMPANY HAS BECOME AWARE OF 17 REPORTS OF FLOW RATE INACCURACIES BETWEEN (B) (6) 2004 AND THE PRESENT. THE COMPANY HAS RECEIVED NO REPORTS OF DEATHS OR SERIOUS INJURIES OR EVENTS THAT LED TO OR REQUIRED MEDICAL INTERVENTION TO PREVENT SERIOUS INJURY, AS A RESULT OF THIS ISSUE. THE HEALTH HAZARD EVAL DETERMINED THAT THE CONDITION PRESENTS AN UNLIKELY RISK OF INJURY TO THE PT GIVEN THE INTENDED USE OF THE PRODUCT; THE INFUSATES FOR WHICH THE PRODUCT IS INTENDED AND, THAT THE RATE OF INFUSION OF THESE AGENTS IS NOT DEPENDANT ON PRECISE TIMED MEASUREMENTS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 READYMED ELASTOMERIC INFUSION SYSTEM MEB CARDINAL HEALTH ALARIS PRODUCTS SEE H10 SEE H10

    Patients

    Seq Age Sex Outcome Treatment
    1