BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ON-SILVERSOAKER

    MDR report key: 2043246 · Received February 25, 2011

    Report

    Report Number
    2026095-2011-00045
    Event Type
    Malfunction
    Date Received
    February 25, 2011
    Date of Event
    July 1, 2008
    Report Date
    July 2, 2008
    Manufacturer
    I-FLOW CORP.
    Product Code
    MEB
    PMA / PMN Number
    K063530
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NY, US
    Reporter Occupation
    NOT APPLICABLE

    Narratives

    Additional Manufacturer Narrative · 1

    I-FLOW RECEIVED ONE EMPTY AND USED PUMP FOR EVAL. THE PUMP WAS REFILLED WITH APPROXIMATELY 65ML OF NORMAL SALINE SOLUTION, AND A GROSS LEAK WAS NOTED AT THE "Y" CONNECTION. A FLOW RATE ACCURACY TEST COULD NOT BE PERFORMED DUE TO THE INTENSITY OF THE LEAK. THE BEST EVIDENCE INDICATES INSUFFICIENT BONDING OF THE JOINT. THIS IS A RARE OCCURRENCE. DUE TO THIS LEAK, FLOW RATE TESTING COULD NOT BE PERFORMED. IN ADDITION, RETAIN SAMPLES FROM LOT 832493 WERE TESTED. THE PUMPS WERE FILLED WITH NORMAL SALINE SOLUTION TO THE NOMINAL FILL VOLUME OF 270ML AND A FLOW RATE ACCURACY TEST WAS PERFORMED. THE FLOW RATE ACCURACY TEST RESULTS WERE FOUND TO BE WITHIN SPECIFICATIONS.

    Description of Event or Problem · 1

    (DRUG/DILUENT: NAROPIN 0.2%). (PROCEDURE: ACL/LATERAL RELEASE). FAST FLOW. PUMP EMPTIED IN 1 HR, BUT PT HAD NO PAIN RELIEF. FILL VOLUME 270ML. NO ADVERSE EVENT OCCURRED. DATE OF EVENT: (B)(6) 2008. PER DFU: THE NOMINAL FILL VOLUME IS 270ML X DUAL 2 (4ML/HR). THE PUMP SHOULD INFUSE IN APPROXIMATELY 67.5 HRS WHEN FILLED TO THE NOMINAL FILL VOLUME.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ON-SILVERSOAKER ELASTOMERIC PUMP MEB I-FLOW CORP. PM025-A 832493

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK