BEUDAMED
    FDA Adverse Event Other Summary report: N

    LT 270-54, EASYPUMP, 270ML, 5ML/HR

    MDR report key: 2823605 · Received November 2, 2012

    Report

    Report Number
    2026095-2012-00262
    Event Type
    Other
    Date Received
    November 2, 2012
    Date of Event
    April 30, 2012
    Report Date
    October 10, 2012
    Manufacturer
    I-FLOW LLC
    Product Code
    MEB
    PMA / PMN Number
    K052117
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    METHOD: THE ACTUAL DEVICE INVOLVED IN THE INCIDENT WAS RECEIVED FOR EVAL AND INVESTIGATION. A REVIEW OF THE DEVICE HISTORY RECORD WAS CONDUCTED FOR THE LOT NUMBER REPORTED. THE DEVICE LOT MET MFG SPECIFICATIONS PRIOR TO RELEASE. A VISUAL EXAM WAS PERFORMED. THE PUMP WAS RECEIVED EMPTY. AN ATTEMPT TO FILL THE PUMP TO NOMINAL VALUE OF 270ML WAS MADE. RESULTS: THE PUMP LEAKED IMMEDIATELY WHEN THE FILLING PROCESS BEGAN. CONCLUSIONS: THE COMPLAINT WAS CONFIRMED. THE CAUSE OF THE LEAK WAS ATTRIBUTED TO A BROKEN O-RING. PER PROCEDURE PR-00598-CORRECTIVE AND PREVENTATIVE ACTION- THIS INCIDENT OF A BROKEN O-RING IS BEING INVESTIGATED UNDER CAPA (B)(4). LEAKING DURING THE FILLING PROCESS DOES NOT MEET THE CRITERIA FOR A REPORTABLE EVENT. (B)(4). (2026095-2012-00262).

    Description of Event or Problem · 1

    DRUG/DILUENT: 5FU. FILL VOLUME: UNK. FLOW RATE: 5.0ML/HR. PROCEDURE: NA. CATHPLACE: NA. PT CONTACT: NO. THE PUMP LEAKED DURING THE FILLING PROCEDURE DURING THE INJECTION OF THE 3RD SYRINGE; LOCATION OF LEAK UNK.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 LT 270-54, EASYPUMP, 270ML, 5ML/HR ELASTOMERIC PUMP MEB I-FLOW LLC 04438043 192387

    Patients

    Seq Age Sex Outcome Treatment
    1 NA