BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED

    MDR report key: 2960940 · Received February 14, 2013

    Report

    Report Number
    6000030-2013-00022
    Event Type
    Injury
    Date Received
    February 14, 2013
    Report Date
    January 23, 2013
    Manufacturer
    RICE CREEK MFG
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    WY, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8709, LOT# L63770, IMPLANTED: (B)(6) 1999. PRODUCT TYPE: CATHETER. (B)(4).

    Description of Event or Problem · 1

    PATIENT REPORTED SHE HAD ISSUES WITH HER PUMP FLIPPING. A DACRON POUCH WAS USED AS WELL AS HAVING THE PUMP ANCHORED TO THE ABDOMINAL WALL. ADDITIONAL INFORMATION HAS BEEN REQUESTED BUT WAS NOT AVAILABLE AT THE TIME OF THIS REPORT.

    Description of Event or Problem · 1

    ADDITIONAL INFORMATION RECEIVED REPORTED THE PATIENT HAD ONE OF THE "ORIGINAL PUMPS" AND THAT "THEY WERE SO BIG, THEY WOULD FLIP OVER." IT WAS NOTED THAT WAS THE REASON THE HEALTH CARE PROVIDER PUT A MESH POUCH IN THE PATIENT. IT WAS REPORTED THE PATIENT'S ORIGINAL CATHETER WAS MADE "TOO SHORT" AND THE HEALTH CARE PROVIDER (HCP) HAD TO "REHOOK IT BACK UP AGAIN" BECAUSE IT HAD BECOME "UNHOOKED AT THE PUMP." THE HCP AT THAT TIME PUT IN THE POUCH AND PUT IN A LONGER CATHETER, HOWEVER THE TIME OF THIS EVENT WAS NOT REPORTED. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    66159 SYNCHROMED PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK RICE CREEK MFG 861718

    Patients

    Seq Age Sex Outcome Treatment
    1 Required Intervention