BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    VERITAS ADVANCED INFUSION PACK

    MDR report key: 16919351 · Received May 12, 2023

    Report

    Report Number
    3012236936-2023-01206
    Event Type
    Malfunction
    Date Received
    May 12, 2023
    Date of Event
    April 18, 2023
    Report Date
    July 26, 2023
    Manufacturer
    AMO MANUFACTURING USA, LLC
    Product Code
    HQC
    UDI-DI
    35050474700902
    PMA / PMN Number
    K203060
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    JA
    Reporter Occupation
    003

    Narratives

    Additional Manufacturer Narrative · 0

    SECTION H10: ADDITIONAL NARRATIVE INFORMATION: SECTION A2, A4 & A5: REQUESTED BUT NOT AVAILABLE AT THE TIME OF THIS REPORT. SECTION E1: EMAIL ADDRESS: UNKNOWN; REQUESTED BUT NOT PROVIDED. SECTION E1: TELEPHONE NUMBER: (B)(6). SECTION H3: H-81 -A REVIEW OF RECORDS RELATED TO THE DEVICE INCLUDING LABELING, COMPLAINT TRENDING, AND RISK DOCUMENTATION WILL BE PERFORMED. UPON COMPLETION OF THIS REVIEW, IF THERE IS ANY FURTHER RELEVANT INFORMATION OBTAINED, A SUPPLEMENTAL MEDWATCH WILL BE FILED. ATTEMPTS WERE MADE TO OBTAIN THE MISSING INFORMATION; HOWEVER, NO RESPONSE HAS BEEN RECEIVED. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON AND JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Additional Manufacturer Narrative · 0

    CORRECTION DATA: AT THE TIME OF THE INITIAL MDR REPORTING FOLLOWING INFORMATION WAS MISSED INADVERTENTLY: DURING THE FIELD SERVICE ENGINEER'S VISIT IT WAS LEARNT THAT PHACO MACHINE WAS THE SUSPECT PRODUCT AND NOT THE TUBING PACK. HENCE THE INITIAL REPORT AGAINST THE TUBING PACK SHOULD NOT HAVE BEEN SUBMITTED. REPORTABILITY HAS BEEN DOWNGRADED TO NOT REPORTABLE EVENT PER OUR PROCEDURES. ALL PERTINENT INFORMATION AVAILABLE TO JOHNSON & JOHNSON SURGICAL VISION, INC. HAS BEEN SUBMITTED.

    Description of Event or Problem · 0

    IT WAS REPORTED THAT SYSTEM HAD ERROR MESSAGE OF GAS FORCED INFUSION PRESSURE BEING TOO HIGH WHILE IN IRRIGATION ASPIRATION MODE. CUSTOMER REPLACED TUBING PACK, HOWEVER THE ISSUE WAS NOT RESOLVED. CUSTOMER UNCHECKED THE ADVANCED INFUSION SETTING, AND THE MACHINE WORKED IN GRAVITY MODE. PROCEDURE WAS SUCCESSFULLY COMPLETED WITH 5 MINUTES DELAY. THERE WAS NO PATIENT INJURY. NO FURTHER INFORMATION PROVIDED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1604371 VERITAS ADVANCED INFUSION PACK UNIT, PHACOFRAGMENTATION HQC AMO MANUFACTURING USA, LLC VRT-AI 60372490 35050474700902

    Patients

    Seq Age Sex Outcome Treatment
    1 Unknown 202210423.