BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3023282 · Received March 27, 2013

    Report

    Report Number
    3004209178-2013-04295
    Event Type
    Malfunction
    Date Received
    March 27, 2013
    Report Date
    February 27, 2013
    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
    PA, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CATHETER: MODEL 8711, SERIAL# (B)(4), IMPLANTED: (B)(6) 2010. ACCESSORY: NEU_REFILLKIT_ACC, LOT# UNKNOWN. (B)(4).

    Additional Manufacturer Narrative · 1

    ACCESSORY REFILL KIT 8565 LIORESAL 2X20MLX20MG EN, LOT# N365563, (B)(4).

    Description of Event or Problem · 1

    THE PATIENT HAD BEEN HAVING "A LOT OF ISSUES WITH SPASMS." THE PATIENT HAD ALSO HAD TWO SURGERIES IN HIS SPINAL COLUMN, ONE PROCEDURE WAS SIX HOURS LONG, ONE WAS TEN HOURS LONG, IT WAS NOT CLEAR WHAT EXACTLY WAS DONE. ONE OF THE SURGERIES, A SPINAL FUSION ON (B)(6) 2013, AFTER WHICH THE FAMILY WAS TOLD THAT THE PUMP "MIGHT HAVE BEEN MANIPULATED A LITTLE BIT," BUT IT WAS NOT REPORTED WHAT WAS MEANT BY THAT. IT WAS NOTED THAT WHILE IN THE HOSPITAL FOR THE SURGERIES, THE PATIENT USE HEAT PACKS AND BLANKETS. ON THE DAY OF THE INITIAL REPORT, THE HEALTHCARE PROVIDER (HCP) EXPECTED 4ML RESIDUAL VOLUME AND ALL SHE DREW BACK WAS "A LOT OF AIR." THE HCP WAS SURE SHE WAS IN THE RESERVOIR AS SHE FELT THE METAL AT THE BOTTOM; SHE DREW BACK "A LITTLE," "EVEN MANIPULATED" THE NEEDLE "A LITTLE." WHEN THE HCP ATTEMPTED TO INJECT PRESERVATIVE FREE NORMAL SALINE INTO THE RESERVOIR THE REFILL KIT WAS DRIPPING A LITTLE AT THE NEEDLE HUB WHERE THE TUBE AND THE NEEDLE CONNECT. THE HCP HAD HOOKED THE KIT UP "PERFECTLY" AND SCREWED IT ON "NICE AND TIGHT," BUT NOTED THAT "IT'S ALL LEAKING AT THE TOP OF THE EXTENSION." THE EXTENSION TUBING WAS DISCONNECTED FROM THE NEEDLE AND THE NEEDLE AND FILTER WERE ATTACHED TO THE NEEDLE HUB AND THE PUMP WAS FILLED WITH 40 ML OF LIORESAL. THE HCP CONFIRMED SHE WAS IN THE PUMP BY ASPIRATING 10ML DURING THE FILL PROCESS.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    125193 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1