BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2941243 · Received February 4, 2013

    Report

    Report Number
    3004209178-2013-01246
    Event Type
    Malfunction
    Date Received
    February 4, 2013
    Report Date
    March 12, 2018
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NC, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE CATHETER NOTED THAT A PORTION OF THE CATHETER WAS RECEIVED. UNDER MICROSCOPE INSPECTION A FAINT CIRCULAR INDENT WAS SEEN IN THE BOTTOM OF THE CUP OF THE SUTURELESS CONNECTOR CONSISTENT WITH THE INNER DIAMETER OF THE TIP OF THE OUTLET PORT OF THE PUMP. A SIGNIFICANT MAJORITY OF THE INDENT WAS LOCATED IN THE SILICONE MATERIAL OF THE CUP OF THE SUTURELESS CONNECTOR. THIS INDICATED THE CONNECTION BETWEEN THE SUTURELESS CONNECTOR AND THE PUMP'S OUTLET PORT MAY POSSIBLY HAVE BEEN OCCLUDED. THE 8709SC WAS INITIALLY OCCLUDED AT IMPLANT WHEN IT WAS TESTED. IT WAS REMOVED AND REPLACED AND THIS WAS WHY THE INDENT IN THE SUTURELESS CONNECTOR CUP WAS SO FAINT.

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8709SC, SERIAL # (B)(4), NOT IMPLANTED, PRODUCT TYPE CATHETER; PRODUCT ID 8578, SERIAL # (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE ACCESSORY. (B)(4). 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.

    Additional Manufacturer Narrative · 1

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

    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 THAT DURING A PROCEDURE, THEY WERE UNABLE TO DRAW THE DRUG OUT OF THE CATHETER ACCESS PORT. THE SUTURE LESS CONNECTOR WAS REPLACED. THERE WERE NO PATIENT SYMPTOMS/INJURIES RELATED TO THIS EVENT. THE PUMP WAS DELIVERING INFUMORPH.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    46913 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 00072 YR