BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3922606 · Received July 9, 2014

    Report

    Report Number
    3004209178-2014-12720
    Event Type
    Malfunction
    Date Received
    July 9, 2014
    Report Date
    June 16, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    AZ, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE CATHETER REVEALED AN INCORRECT ASSEMBLY OR SUTURE AT THE PUMP CONNECTOR. A SMALL PORTION OF THE CATHETER WAS RETURNED, INCLUDING A STRAIGHT PUMP CONNECTOR. THERE WERE INDENTS IN THE SUTURE RING AREA OF THE CONNECTOR, WHICH INDICATED THAT A SUTURE HAD BEEN APPLIED THERE. HOWEVER, THERE WERE UNUSUAL INDENTS ON THE OUTSIDE SURFACE OF THE MOST PROXIMAL PART OF THE CONNECTOR. THESE INDENTS ARE NOT TYPICALLY SEEN ON SIMILAR CONNECTORS THAT HAVE BEEN RETURNS. THE LOCATION OF THESE UNUSUAL INDENTS MAY HAVE INDICATED THAT THE CATHETER WAS NOT CORRECTLY ATTACHED TO THE OUTLET PORT OF THE PUMP.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID: 8711, LOT# J11417R70, IMPLANTED: (B)(6) 2003, EXPLANTED: (B)(6) 2014, PRODUCT TYPE: CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, ON THE DATE OF THIS REPORT, A BREAK AND DISCONNECTION OCCURRED AT THE PUMP CONNECTOR. THE CATHETER WAS REPLACED ON THE SAME DATE. THE EVENT WAS INDICATED TO HAVE OCCURRED DURING A PROCEDURE. THERE WERE NO PATIENT SYMPTOMS OR COMPLICATIONS ASSOCIATED WITH THE EVENT. THE PATIENT STATUS AT THE TIME OF THIS REPORT WAS INDICATED TO BE ¿ALIVE-NO INJURY¿. IT WAS LATER REPORTED THAT THE PREVIOUSLY REPORTED EVENT WAS DETERMINED WHEN THE SITE WAS OPENED FOR A PUMP REPLACEMENT, WHICH WAS DONE FOR END OF LIFE (EOL).

    Description of Event or Problem · 1

    THE PUMP REACHED NORMAL BATTERY DEPLETION.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    401041 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00065 YR