BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3120832 · Received May 20, 2013

    Report

    Report Number
    3004209178-2013-07937
    Event Type
    Injury
    Date Received
    May 20, 2013
    Report Date
    April 22, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-1060-2011
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE PUMP REVEALED NO ANOMALIES. THERE WERE ALLEGATIONS ABOUT PROBLEMS WITH THE PUMP AT THE REFILL. THE LAB DID NOT EXPERIENCE ANY ISSUES ASPIRATING OR FILLING THE PUMP. THE PUMP WAS SUBMERGED IN DEIONIZED WATER WITH A NEEDLE IN THE FILL PORT. THE NEEDLE WAS CONNECTED TO A 35 PSI AIR SUPPLY, AND THAT PRESSURE WAS HELD FOR ONE MINUTE, WITH NO LEAKING FROM THE SEPTUM OBSERVED. (B)(4).

    Additional Manufacturer Narrative · 1

    (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

    A REPRESENTATIVE LATER REPORTED THAT A VOLUME DISCREPANCY OCCURRED. IT WAS NOTED THAT ¿THE PUMP WORKS, BUT MEDICATION WAS IN THE SUBCUTANEOUS POCKET¿. THE PATIENT WAS ¿TIRED¿. THE PUMP WAS REPLACED ON 6/13/2013.

    Description of Event or Problem · 1

    AFTER A REGULAR PUMP REFILL PROCEDURE, AND AFTER THE PHYSICIAN REMOVED THE NEEDLE, THE PHYSICIAN OBSERVED A SUDDEN SWELLING OF THE AREA ABOVE AND AROUND THE PUMP. HE INTERPRETED THIS AS DRUG FLOWING OUT OF THE PUMP. HE ASPIRATED SOME DRUG VOLUME OUT OF THE POCKET AND STILL OBSERVED HOW MORE FLUID ¿OBVIOUSLY CAME OUT OF THE PUMP¿. HE ASPIRATED AS MUCH FLUID AS HE COULD GET OUT OF THE POCKET. NO PATIENT SYMPTOMS OR INJURIES WERE RELATED TO THIS EVENT, AND THE PATIENT¿S STATUS WAS NOTED AS ALIVE AND WITHOUT INJURY. IT WAS LATER REPORTED THAT THE REFILL/ASPIRATION PROCEDURE WAS PERFORMED CORRECTLY. THE MEDICATION USED WITHIN THE SYSTEM WAS MORPHINE. THE PUMP WAS NOT REPLACED. THE LAST REFILL WAS PERFORMED WITH NACL, AND THE LAST ASPIRATION (ML NACL) WAS CORRECT. THE PHYSICIAN WAS CURRENTLY TESTING PRIALT. THE PATIENT WAS DOING WELL WITH THE SAME SIDE EFFECTS. THE PATIENT¿S DAILY DOSE WAS REDUCED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    222809 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 Other| R