BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED EL

    MDR report key: 2874547 · Received December 15, 2012

    Report

    Report Number
    6000031-2012-00003
    Event Type
    Injury
    Date Received
    December 15, 2012
    Report Date
    November 14, 2012
    Manufacturer
    RICE CREEK MFG
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TN, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4)

    Additional Manufacturer Narrative · 1

    FINAL ANALYSIS OF THE PUMP REVEALED GEAR TRAIN ANOMALY, CORROSION AND/OR WEAR AND/OR LUBRICATION. FINAL ANALYSIS OF THE CATHETER REVEALED CATHETER BODY DISCOLORATION AND DARK RESIDUE OCCLUSION IN DISPENSING HOLES, EVENT RELATED.

    Additional Manufacturer Narrative · 1

    CONCOMITANT MEDICAL PRODUCTS: PRODUCT ID 8709, LOT# J0177986R, IMPLANTED: (B)(6) 2002, EXPLANTED: (B)(6) 2012. PRODUCT TYPE: CATHETER. (B)(4).

    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 THE ENTIRE DEVICE SYSTEM WAS REPLACED. IT WAS INDICATED THAT THE PUMP WAS PROPHYLACTICALLY REMOVED TO AVOID IN VIVO BATTERY DEPLETION. DURING NORMAL PUMP REPLACEMENT, THE PHYSICIAN WAS UNABLE TO ASPIRATE ANY FLUID FROM THE CATHETER. THE PHYSICIAN NEVER ATTEMPTED TO PUSH BACK IN AND INSTEAD DECIDED TO REPLACE THE CATHETER AS WELL. X-RAY SHOWED THAT THE CATHETER WAS IN IT'S CORRECT POSITION. AFTER CATHETER EXPLANT, THEY NOTICED SOME "BLACK SLUDGE" INSIDE THE CATHETER. THERE WAS NO VOLUME DISCREPANCIES NOTED. IT WAS INDICATED THAT THERE WAS NO NEW PATIENT SYMPTOMS, HOWEVER SHE WAS ON ORAL MEDICATIONS FOR BREAK-THROUGH PAIN. IT WAS NOTED THAT THE PATIENT WAS ADMITTED AND WAS BEING KEPT OVER-NIGHT FOR MONITORING. THE OUTCOME OF THE PATIENT WAS REPORTED AS RECOVERED WITHOUT SEQUELAE. THE DRUG DELIVERED VIA PUMP WAS MORPHINE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    1 SYNCHROMED EL PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK RICE CREEK MFG 8627L18

    Patients

    Seq Age Sex Outcome Treatment
    1 00053 YR Hospitalization