BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 2955805 · Received February 11, 2013

    Report

    Report Number
    3004209178-2013-02536
    Event Type
    Malfunction
    Date Received
    February 11, 2013
    Date of Event
    January 15, 2013
    Report Date
    January 15, 2013
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    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

    ANALYSIS OF THE PUMP REVEALED NO ANOMALIES. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4). ANALYSIS RESULTS WERE NOT AVAILABLE AS OF THE DATE OF THIS REPORT. A FOLLOW-UP REPORT WILL BE SUBMITTED WHEN ANALYSIS IS COMPLETE.

    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 THERE WAS A PROBLEM ASPIRATING A NEW PUMP PRIOR TO IMPLANTING, AND THAT THE PUMP ULTIMATELY WAS NOT USED AND A NEW PUMP WAS IMPLANTED. ON THE DATE OF REPORT, THE REPORTER INDICATED THAT WHILE ATTEMPTING TO FLUSH PRESERVATIVE FREE NORMAL SALINE (PFNS) INTO THE CATHETER ACCESS PORT (CAP) OF A BRAND NEW PUMP, ON THE BACK SURGICAL TABLE PRIOR TO IMPLANT, THAT THE PUSHING WAS "VERY RESTRICTIVE." MULTIPLE NEEDLES WERE USED AND THE SAME PROBLEM WAS ENCOUNTERED WITH EACH. THE REPORTER INDICATED THAT THE NEEDLE WAS SECURED TO THE SYRINGE AND THERE WAS NO PROBLEM IN EMPTYING PUMP. IT WAS DECIDED TO USE A NEW PUMP AS THEY COULD NOT PUSH ANY FLUIDS WITHOUT EXCESSIVE FORCE, AND A CAP OCCLUSION WAS SUSPECTED. AS THE PUMP WAS NEVER USED WITH THE PATIENT, THE PUMP WAS NEVER FILLED WITH DRUG FOLLOWING THE ASPIRATION OF STERILE WATER. FOLLOWING THE PROCEDURE WITH A NEW PUMP, THE PATIENT WAS REPORTED TO BE "DOING FINE" AND HAD RECOVERED WITHOUT SEQUELAE. A FOLLOW-UP REPORT WILL BE SENT IF ADDITIONAL INFORMATION BECOMES AVAILABLE.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    58722 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637

    Patients

    Seq Age Sex Outcome Treatment
    1 00059 YR