BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3111182 · Received May 14, 2013

    Report

    Report Number
    3004209178-2013-07612
    Event Type
    Malfunction
    Date Received
    May 14, 2013
    Date of Event
    April 15, 2013
    Report Date
    April 15, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    FR
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    UPON LABORATORY ARRIVAL AN X-RAY WAS TAKEN BEFORE THE RESERVOIR WAS ACCESSED. TEN MILLILITERS (ML) OF FLUID WERE ASPIRATED WHEN THE RESERVOIR WAS FIRST ACCESSED IN THE LABORATORY. THE PUMP PASSED ALL NON-DESTRUCTIVE TESTING, WITH RESERVOIR ACCESS ISSUES ENCOUNTERED. THE PUMP WAS THEN FILLED WITH 20 ML OF STERILE WATER, AND ASPIRATED A TOTAL OF FIVE TIMES, WITH NO PROBLEMS ENCOUNTERED. THE PUMP WAS THEN FILLED WITH 10 ML OF STERILE WATER, ASPIRATED A TOTAL OF FIVE TIMES, WITH NO PROBLEMS ENCOUNTERED. THE RESERVOIR ACCESS COMPLAINT COULD NOT BE DUPLICATED IN THE LABORATORY.

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS RESULTS WERE NOT AVAILABLE AT THE TIME OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SENT WHEN ANALYSIS IS COMPLETED.

    Additional Manufacturer Narrative · 1

    IF INFORMATION IS PROVIDED IN THE FUTURE, A SUPPLEMENTAL REPORT WILL BE ISSUED.

    Description of Event or Problem · 1

    IT WAS REPORTED THERE WERE DIFFICULTIES FILLING AND ASPIRATING THE PUMP. THE PHYSICIAN WAS ABLE, WITH DIFFICULTY, TO INJECT "ONLY 7 MLS" INTO THE PUMP. HE ALSO REPORTED DIFFICULTIES DRAINING THE PUMP. HE WAS ABLE TO REMOVE "ONLY 14 MLS." THE PUMP WAS NEVER IMPLANTED IN A PATIENT.

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT PRIOR TO THE PUMP IMPLANT PROCEDURE, THE SURGEON COULD NOT FILL THE PUMP. THE SURGEON EXPERIENCED ¿A LOT OF DIFFICULTIES TO EMPTY 4 OR 5 ML OF WATER.¿

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    212833 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1