BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    INFUSOR LV5, 12 PK

    MDR report key: 1905003 · Received November 22, 2010

    Report

    Report Number
    6000001-2010-05107
    Event Type
    Malfunction
    Date Received
    November 22, 2010
    Date of Event
    October 27, 2010
    Report Date
    October 27, 2010
    Manufacturer
    BAXTER HEALTHCARE - IRVINE
    Product Code
    MEB
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4). THE DEVICE IS AVAILABLE FOR EVALUATION PER THE CUSTOMER; HOWEVER, THE DEVICE HAS NOT YET BEEN RECEIVED BY BAXTER. SHOULD THE DEVICE AND/OR ANY ADDITIONAL INFORMATION BECOME AVAILABLE, A FOLLOW-UP REPORT WILL BE SUBMITTED. THIS DEVICE IS MANUFACTURED FOR DISTRIBUTION OUTSIDE OF THE UNITED STATES (US); THEREFORE, IT DOES NOT CONTAIN A US 510K NUMBER. HOWEVER, THIS MDR IS BEING SUBMITTED BECAUSE IT IS THE SAME AS OR SIMILAR TO A PRODUCT DISTRIBUTED WITHIN THE US.

    Additional Manufacturer Narrative · 1

    (B)(4). DEVICE EVALUATION: ONE SAMPLE WAS RECEIVED BY BAXTER FOR EVALUATION CONTAINING APPROXIMATELY 60 ML OF FLUID AT THE BOTTOM OF THE HOUSING WHICH INDICATED LEAKAGE HAS OCCURRED. EXAMINATION OF THE SAMPLE CONFIRMED THE REPORTED CONDITION OF "LEAKAGE" WAS DUE TO A MISSING FILM-WRAP. THE RESERVOIR WAS FOUND COMPLETELY ATTACHED TO THE STRESS-MEMBER. NO OTHER OBSERVATION WAS NOTED ON THE SAMPLE. THE ROOT CAUSE OF THE MISASSEMBLED FILM-WRAP CONDITION WAS DUE TO OPERATOR ERROR DURING THE FILM WRAP ASSEMBLY PROCESS. BAXTER WILL CONTINUE TO MONITOR SIMILAR REPORTS TO DETERMINE IF FURTHER ACTIONS ARE REQUIRED. A BATCH REVIEW WAS CONDUCTED AND NO ISSUES WERE FOUND RELATED TO THE REPORTED CONDITION DURING THE MANUFACTURE OF THE LOT.

    Description of Event or Problem · 1

    IT WAS REPORTED TO BAXTER (B)(4) THAT ONE (1) INFUSOR LV5 DEVICE WAS OBSERVED LEAKING FROM THE RESERVOIR DURING FILLING. THE DEVICE WAS BEING FILLED WITH NORMAL SALINE. ACCORDING TO THE REPORT, THE RESERVOIR DID NOT SEEM TO BE ATTACHED TO THE STRESS MEMBER POST. THERE IS NO REPORT OF PATIENT INJURY OR MEDICAL INTERVENTION. NO ADDITIONAL INFORMATION IS AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 INFUSOR LV5, 12 PK PUMP, INFUSION, ELASTOMERIC MEB BAXTER HEALTHCARE - IRVINE 10E052

    Patients

    Seq Age Sex Outcome Treatment
    1