BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    ACCURUS 800CS

    MDR report key: 1840031 · Received September 15, 2010

    Report

    Report Number
    2028159-2010-01746
    Event Type
    Malfunction
    Date Received
    September 15, 2010
    Date of Event
    August 16, 2010
    Report Date
    August 16, 2010
    Manufacturer
    ALCON - IRVINE TECHNOLOGY CENTER
    Product Code
    HQC
    PMA / PMN Number
    K911808
    Removal / Correction Number
    NA
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    CA, US
    Reporter Occupation
    NURSE

    Narratives

    Additional Manufacturer Narrative · 1

    THE COMPANY SERVICE REP EXAMINED THE SYSTEM AND FOUND LOW VACUUM WAS CAUSED BY THE TOP RIGHT PINCH PLUNGER BEING EXTENDED. THE LOOSE PLUNGER PRESSURE LINE WAS RECONNECTED. THE IV HOOK ASSEMBLY WAS INSTALLED AND THE LATCH SEAL WAS REPLACED. THE SYSTEM WAS THEN TESTED AND MET ALL PRODUCT SPECS. (B)(4).

    Description of Event or Problem · 1

    ADVERSE EVENT(S): "NO PT INJURY REPORTED" (NO CONSEQUENCES OR IMPACT TO PT). PRODUCT PROBLEM(S): "NO VACUUM" (ASPIRATION ISSUE); "WOULD NOT PRIME" (FAILURE TO PRIME). THE NURSE REPORTED THE SYSTEM WOULD NOT HOLD VACUUM. ADD'L INFO RECEIVED FROM THE NURSE STATED THAT INITIALLY THE SYSTEM WOULD NOT PRIME. THE NURSE CALLED THE COMPANY TECHNICAL SUPPORT SPECIALIST (TSS) AND WAS WALKED THROUGH THE PRIMING SEQUENCE. THEN, THE NURSE NOTED THAT VACUUM WOULD NOT BUILD. THIS OCCURRED DURING SET UP. A SYSTEM WAS BORROWED FROM A NEIGHBORING FACILITY. THE CASES WERE DELAYED 2 HOURS. TWO OF THE THREE SCHEDULED CASES WERE COMPLETED THE SAME DAY, WHILE THE OTHER WAS COMPLETED THE FOLLOWING DAY. NO PT INJURY WAS REPORTED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 ACCURUS 800CS PHACOFRAGMENTATION SYSTEM HQC ALCON - IRVINE TECHNOLOGY CENTER ACCURUS NA

    Patients

    Seq Age Sex Outcome Treatment
    1 UNK