BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED EL

    MDR report key: 2881937 · Received December 20, 2012

    Report

    Report Number
    6000030-2012-00227
    Event Type
    Malfunction
    Date Received
    December 20, 2012
    Date of Event
    October 17, 2012
    Report Date
    December 13, 2012
    Manufacturer
    RICE CREEK MFG.
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    MI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). ANALYSIS OF THE PUMP FOUND PUMP MOTOR GEAR TRAIN ANOMALY AND RESIDUE. CORROSION AND WEAR AND LACK OF LUBRICATION WERE ALSO FOUND.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PUMP WAS PROPHYLACTICALLY REMOVED TO AVOID IN-VIVO BATTERY DEPLETION. IT WAS INDICATED THAT THERE WAS NO PATIENT INJURY. THERE WAS NO TROUBLE-SHOOTING PERFORMED. THE DRUGS DELIVERED VIA PUMP WERE BUPIVACAINE AND HYDROMORPHONE.

    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 00064 YR