BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2904082 · Received January 9, 2013

    Report

    Report Number
    3004209178-2013-00343
    Event Type
    Injury
    Date Received
    January 9, 2013
    Report Date
    December 14, 2012
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MN, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2012. PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    THE PATIENT CAME IN FOR A REFILL ON (B)(6) 2012. THE HEALTHCARE PROVIDER (HCP) WAS TRYING TO REFILL THE PUMP UNDER FLUORO AND THE NEEDLE KEPT SLIDING OFF THE PUMP. WHEN THE CAP (CATHETER ACCESS PORT) WAS ORIENTED IN THE 12 O'CLOCK POSITION, THE PUMP CONNECTOR WAS AT THE 9 O'CLOCK POSITION, WHICH WAS OPPOSITE OF THE WAY IT SHOULD BE SUGGESTING THE PUMP MIGHT BE FLIPPED. AN X-RAY CONFIRMED THE PUMP WAS FLIPPED. THE PATIENT HAD APPROXIMATELY 8 DAYS OF DRUG REMAINING IN THE PUMP. THEY WERE PLANNING TO REVISE THE PUMP IN 3 DAYS. THE PATIENT DID NOT HAVE ANY SYMPTOMS RELATED TO THE EVENT. THE PUMP WAS DELIVERING BACLOFEN. ADDITIONAL INFORMATION HAS BEEN REQUESTED; A FOLLOW-UP REPORT WILL BE SENT IF INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    10875 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention