BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3182951 · Received June 21, 2013

    Report

    Report Number
    3004209178-2013-10726
    Event Type
    Malfunction
    Date Received
    June 21, 2013
    Report Date
    May 28, 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 Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCT: PRODUCT ID 8709SC, SERIAL# (B)(4), IMPLANTED: (B)(6) 2009,PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    THE PATIENT REPORTED THAT THEIR PHYSICIAN WAS PULLING OUT MORE THAN THEY SHOULD HAVE. THEY NOTED THE PAST TWO TIMES ¿IT SHOULD HAVE HAD 1 ML AND THEY WERE WAY OVER¿ AND THEY WERE NOT ABLE TO GET IT FILLED. THEY STATED THEY WENT UP A DAY BEFORE THEIR ALARM DATE. THE PHYSICIAN SAID THEY WERE ONLY GOING TO PULL OUT 1 ML AND THEY PULLED OUT 5. ANOTHER TIME THE PHYSICIAN WAS SUPPOSED TO PULL OUT 5.6 ML AND THEY PULLED OUT 6.5 ML. THE LATTER DISCREPANCY WAS NOTED TO HAVE OCCURRED WHEN THE PHYSICIAN FILLED THE PUMP HALF WAY WITH 20 ML¿S. THEY STATED THE ONE TO FIVE ML DISCREPANCY OCCURRED ON (B)(6). THEY STATED THE 5.6 TO 6.5 DISCREPANCY OCCURRED ON (B)(6). THE PATIENT REPORTED THEY WERE SUPPOSED TO PULL OUT 4.5 ML AND THEY GOT 5.6 ML AT THAT TIME. THEIR PHYSICIAN MENTIONED ¿SOMETHING ABOUT REPLACING THE PUMP OR THE CATHETER¿. THE PATIENT CONFIRMED THAT THEY WERE ¿GETTING GOOD THERAPY¿ AND IT WAS HELPING. THEY NOTED THEIR PHYSICIAN PERFORMED AN X-RAY AND PUT DYE INTO THE PORT HOLE ON (B)(6) 2013. THE PHYSICIAN STATED THEY ¿DID NOT THINK IT WAS GOING TO THEIR SPINE,¿ BUT THE PATIENT STATED ¿THEY WERE GETTING IT, YOU KNOW¿. THEY STATED THEY PUT DYE IN THE PRIME HOLE AND ¿COULD NOT TELL WHERE IT WAS GOING¿; THAT ¿IT WAS NOT SHOWING UP IN THE SPINE¿; THAT THE PATIENT ¿NEEDED SURGERY¿. THEY STATED THAT THEIR PHYSICIAN FOUND SOMETHING WRONG WITH THE CATHETER, AND THAT THE LIORESAL WAS NOT GOING TO THE SPINE. AT THE REFILL ON (B)(6), THE PHYSICIAN NOTED THE 1.1 ML DIFFERENCE AND INDICATED THAT ¿IT WAS NOT ANY BIG DEAL¿. THE PATIENT¿S NEXT REFILL APPOINTMENT WAS SCHEDULED FOR (B)(6) 2013. NO SURGERY WAS SCHEDULED. THE PATIENT STATED THAT ¿SOMETHING WAS WRONG WITH THE PUMP¿ AND THAT WAS WHY THERE WAS A BIGGER AMOUNT OF MEDICATION. THE MEDICATION USED WITHIN THE SYSTEM WAS LIORESAL. ALL OF THE REPORTED VOLUME DISCREPANCIES WERE NOTED TO BE WITHIN SPECIFICATION. A HEALTHCARE PROVIDER LATER REPORTED THE MEDICATION USED WITHIN THE SYSTEM WAS GABLOFEN. THE CAUSE OF THE EVENT WAS NOTED TO BE A MINOR DISCREPANCY IN RESIDUAL VOLUME AND WAS RESOLVED WITH (ILLEGIBLE) REFILL. NO SIGNS OR SYMPTOMS WERE ASSOCIATED WITH THE EVENT, AND NO INJURY OCCURRED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    282918 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00055 YR