BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SIGNATURE PACK, DISPOSABLE TUBING

    MDR report key: 2193343 · Received July 29, 2011

    Report

    Report Number
    2020664-2011-00055
    Event Type
    Injury
    Date Received
    July 29, 2011
    Date of Event
    June 24, 2011
    Report Date
    July 22, 2011
    Manufacturer
    ADVANCED MEDICAL OPTICS, INC.
    Product Code
    HQC
    PMA / PMN Number
    K060366
    Adverse Event
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WA, US
    Reporter Occupation
    UNKNOWN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4) DELAYED PROCEDURE. EVALUATION CODE: RESULTS: TERRITORY MANAGER PERFORMED A "SHAKE TEST" AND DETERMINED THE ISSUE WITH THE PACK. THE AMO TERRITORY MANAGER (TM) VISITED THE CUSTOMER SITE AND FOUND THAT THE PROBLEM IS DUE TO AN (B)(4) TUBING PACK. PER THE TERRITORY MANAGER, THE BALL BEARING IN THE DRIP SPIKE PREVENTED THE BBS (BALANCED SALT SOLUTION) FROM FLOWING CORRECTLY, RESULTING IN THE REPORTED 501 PRIMING ERROR. INVESTIGATION OF THE TUBING PACK AT THE MANUFACTURING SITE IS NOT POSSIBLE AS THE LOT NUMBER WAS NOT REPORTED AND THE TUBING PACK WAS NOT RETURNED. THE PATIENT'S PROCEDURE WAS DELAYED ONE HOUR AND 15 MINUTES DURING TROUBLESHOOTING BY THE CUSTOMER FOR THE REPORTED EVENT. DURING THIS DELAY, ALTHOUGH THE PATIENT'S IV (INTRAVENOUS) SEDATION WORE OFF, THE PATIENT WAS CLINICALLY STABLE. THE PROCEDURE WAS COMPLETED WITH A BACK-UP PHACO SYSTEM WITHOUT FURTHER REPORTED PROBLEMS. NO FIELD SERVICE WAS DISPATCHED OR INDICATED AS THE REASON FOR THE PROBLEM WAS VERIFIED DURING THE SITE VISIT BY THE TERRITORY MANAGER. THE TERRITORY MANAGER CONFIRMED THAT THE TUBING PACK WAS A MODEL OPO71 AND REPORTED THAT THE LOT NUMBER WAS UNKNOWN AND THE TUBING PACK WAS NOT AVAILABLE FOR EVALUATION BY AMO BECAUSE THE CUSTOMER THREW THE PACK AWAY BEFORE THE TERRITORY MANAGER COULD COLLECT THE PACK FOR EVALUATION. SPECIFIC PATIENT INFORMATION WAS NOT PROVIDED BY THE FACILITY. (B)(4).

    Description of Event or Problem · 1

    CUSTOMER REPORTED THAT THE SYSTEM FAILED TO PRIME AND GAVE ERRORS. CUSTOMER POWERED DOWN SYSTEM 3 TIMES AND REBOOTED. THEY WERE UNSUCCESSFUL TO PASS AN IRRIGATION/ASPIRATION (I/A) PRIME. THEY ALSO TRIED TO RAISE THE BOTTLE HEIGHT & THAT DID NOT RESOLVE PROBLEM. PATIENT WAS IN THE OPERATING ROOM AND SEDATED, HOWEVER, AN INCISION WAS NOT MADE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SIGNATURE PACK, DISPOSABLE TUBING HQC ADVANCED MEDICAL OPTICS, INC. OPO71 UNK

    Patients

    Seq Age Sex Outcome Treatment
    1 NONE REPORTED