BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ON-SILVERSOAKER 2.5IN (6.5CM), 270ML X 5ML/HR

    MDR report key: 2153010 · Received June 17, 2011

    Report

    Report Number
    2026095-2011-00166
    Event Type
    Malfunction
    Date Received
    June 17, 2011
    Date of Event
    May 26, 2011
    Report Date
    May 26, 2011
    Manufacturer
    I-FLOW CORP.
    Product Code
    MEB
    PMA / PMN Number
    K063530
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    GA, US
    Reporter Occupation
    PHARMACIST

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: SAMPLE HAS NOT YET BEEN RECEIVED, BUT WAS REPORTED TO BE AVAILABLE. A REVIEW OF THE DEVICE HISTORY RECORDS (DHR) WAS CONDUCTED FOR THE LOT NUMBER AND INCIDENT REPORTED. THE DEVICE PASSED ALL MFG SPECS PRIOR TO RELEASE. RESULTS: WITHOUT THE ACTUAL PRODUCT, AN ANALYSIS CANNOT BE CONDUCTED. CONCLUSIONS: THE SAMPLE WILL BE EVALUATED WHEN RECEIVED AND A FOLLOW-UP REPORT WILL BE FILED.

    Description of Event or Problem · 1

    DRUG/DILUENT: MARCAINE 0.5%. FILLED VOLUME: 330ML AND FLOW RATE: 5ML/HR. PROCEDURE: COLECTOMY. CATHPLACE: ABDOMEN, UNSURE OF SIDE. FAST INFUSION. PT HAD SURGERY ON TUESDAY, (B)(6) 2011 AND WAS GIVEN A PUMP. NURSE NOTICED THAT PUMP WAS EMPTY BY 6AM THURSDAY MORNING, (B)(6) 2011. SHE CALLED THE SURGEON, WHO PULLED THE PUMP AND GAVE IT TO THE PHARMACIST TO INVESTIGATE. NO ADVERSE EVENT REPORTED. PER DFU: LABELED FLOW RATE: 5ML/HR. LABELED FILL VOLUME: 270ML. MAXIMUM FILL VOLUME: 335ML. THE INFUSION DELIVERY TIME FOR THE VOLUME OF 330ML IS 72 HOURS, 3 DAYS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ON-SILVERSOAKER 2.5IN (6.5CM), 270ML X 5ML/HR ELASTOMERIC PUMP MEB I-FLOW CORP. PM014-A 9A2109

    Patients

    Seq Age Sex Outcome Treatment
    1 51 YR