BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    MICRO CHPV UNITIZED

    MDR report key: 12193064 · Received July 19, 2021

    Report

    Report Number
    3013886523-2021-00312
    Event Type
    Malfunction
    Date Received
    July 19, 2021
    Report Date
    November 3, 2021
    Product Code
    JXG
    PMA / PMN Number
    K053107
    Report Source
    Manufacturer report
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 0

    THE VALVE WAS RETURNED FOR EVALUATION. REVIEW OF THE HISTORY DEVICE RECORDS FOR THE PRODUCT CODE 823114 WITH LOT 3285940 CONFORMED TO THE SPECIFICATIONS WHEN RELEASED TO STOCK. FAILURE ANALYSIS: THE VALVE WAS VISUALLY INSPECTED, NO DEFECTS WERE NOTED. THE VALVE PASSED THE TESTS FOR PROGRAMMING, OCCLUSION, LEAK. THE VALVE FAILED THE TESTS FOR REFLUX AND PRESSURE. THE VALVE WAS DISMANTLED AND WAS EXAMINED UNDER MICROSCOPE AT APPROPRIATE MAGNIFICATION: BIOLOGICAL DEBRIS WAS FOUND IN THE HOUSING ON THE SPRING, ON THE RUBY BALL AND ON THE SEAT OF RUBY BALL. THE ROOT CAUSE FOR THE ISSUE REPORTED BY THE CUSTOMER, IS DUE TO BIOLOGICAL DEBRIS FOUND ON THE SPRING, ON THE RUBY BALL AND ON THE SEAT OF THE RUBY BALL, THIS BIOLOGICAL DEBRIS WAS STOPPING THE RUBY BALL FROM BEING SEATED CORRECTLY.

    Additional Manufacturer Narrative · 1

    AN INVESTIGATION HAS BEEN INITIATED BASED ON THE REPORTED INFORMATION. UPON COMPLETION OF THE INVESTIGATION, A FOLLOW-UP REPORT WILL BE SUBMITTED.

    Description of Event or Problem · 1

    A FACILITY REPORTED A HAKIM VALVE WAS IMPLANTED VIA VENTRICULAR PERITONEAL SHUNT ON (B)(6) 2021 AND IT WAS NOT DRAINING AS EXPECTED. THE VALVE WAS REPLACED ON (B)(6) 2021. THE VALVE WAS USED TO TREAT CONGENITAL HYDROCEPHALUS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1084337 MICRO CHPV UNITIZED CHPV JXG 3285940

    Patients

    Seq Age Sex Outcome Treatment
    1