BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3932687 · Received July 14, 2014

    Report

    Report Number
    3004209178-2014-12979
    Event Type
    Injury
    Date Received
    July 14, 2014
    Report Date
    January 30, 2017
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Removal / Correction Number
    Z-1570-2014
    Adverse Event
    Yes
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    NV, US
    Reporter Occupation
    OTHER

    Narratives

    Additional Manufacturer Narrative · 1

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

    Additional Manufacturer Narrative · 1

    ANALYSIS OF THE PUMP FOUND A SIGNIFICANT ANOMALY. IT WAS DETERMINED THAT THERE WAS OVERINFUSION WITH AN UNDETERMINED ROOT CAUSE. THIS PUMP HAD AN INFUSION ACCURACY TEST FAILURE AS DEFINED IN (B)(4). IT WILL NOT UNDERGO FURTHER TESTING PER (B)(4) AND IS ON HOLD FOR DESTRUCTIVE ANALYSIS AT THE DISCRETION OF THE (B)(4) (OVERINFUSION) INVESTIGATION TEAM. ANALYSIS OF THE SUTURELESS CONNECTOR (SC) FOUND NO SIGNIFICANT ANOMALY. ONLY THE SC HAD BEEN RETURNED FOR ANALYSIS, NO CATHETER. THERE WAS A SLIGHT, NON-SIGNIFICANT INDENT ON THE INSIDE OF THE SC CUP NEAR INNER LUMEN WHICH DID NOT AFFECT INFUSION. THERE WAS VERY SLIGHT DAMAGE TO ONE OF THE RETAINING RING FINGERS.

    Additional Manufacturer Narrative · 1

    DESTRUCTIVE ANALYSIS OF THE PUMP WAS COMPLETED AND NO ADDITIONAL ANOMALIES WERE FOUND. (B)(6).

    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

    IT WAS REPORTED THAT TWO MONTHS PRIOR TO REPORT, THE PATIENT HAD BEEN ACTING VERY DRUGGED AND VERY OVER-MEDICATED. THE PATIENT REPORTEDLY WOULD GET THE PUMP REFILLED EVERY THREE MONTHS, AND SINCE THE PUMP REFILL IN (B)(6) 2014, THE CALLER NOTICED THAT THE PATIENT WAS SLEEPING MORE AND BEING VERY LETHARGIC. THE PATIENT THEN WENT TO THEIR HEALTHCARE PROFESSIONAL (HCP) FOR A REFILL ON (B)(6) 2014 AND A TEST WAS DONE RESULTING IN A CATHETER KINK BEING DISCOVERED. A SURGERY TO FIX THE CATHETER KINK WAS DONE ON 2014-06-18. THE ENTIRE SYSTEM WAS REPLACED AS THE PATIENT HAD BEEN "TALKING LIKE HE WAS DRUNK" AND "COULD NOT HOLD A CONVERSATION". THE PATIENT WAS REPORTEDLY GETTING 10 TO 20 TIMES THE AMOUNT OF MEDICATION THAT THE PATIENT SHOULD HAVE HAD. IT WAS NOTED THAT WHEN THEY PULLED THE MEDICATION OUT, THERE WERE 4 ML THAT WERE UNACCOUNTED FOR. THE MANUFACTURER'S REPRESENTATIVE REPORTEDLY TOLD THE CALLER THAN THE PUMP WAS MALFUNCTIONING AND WAS GOING TO BE SENT BACK TO THE MANUFACTURER FOR ANALYSIS. THE PUMP WAS INTENDED TO INFUSE MORPHINE, CLONIDINE, AND BUPIVACAINE. IT WAS LATER REPORTED BY THE PATIENT'S WIFE THAT AT THE REFILL IN (B)(6) 2014, THEY NOTICED THAT THEY WERE "A LITTLE SHORT" WHEN THEY PULLED IT OUT, BUT THEY WERE NOT WORRIED ABOUT IT AS IT WAS NOT ENOUGH TO MAKE THEM WORRY. IT WAS NOTED THAT IN (B)(6), THE PATIENT WAS SICK AND "ACTING SUPER DOPY" BUT THE NEXT REFILL WAS IN JUNE SO THE HCP REPORTEDLY STATED THAT THEY "WOULD LOOK AT IT THEN". THE CALLER STATED THAT THE PATIENT WAS "A ZOMBIE UNTIL THEN AND SLEEPING 20 HOURS A DAY AND NODDING OUT LIKE A HEROINE ADDICT". DURING THE REFILL ON (B)(6) 2014, THE CALLER STATED THAT SHE "KNEW SOMETHING WAS WRONG" WHEN 4 ML OF DRUG WAS UNACCOUNTED FOR. FLUOROSCOPY DETERMINED THAT THERE WAS A KINK IN THE CATHETER. IT WAS NOTED THAT A MANUFACTURER'S REPRESENTATIVE WAS AT THE PUMP REPLACEMENT SURGERY AND WAS THE ONE WHO NOTICED THAT THE PUMP WAS NOT WORKING AND "SHE SAID THEY HAD TO GET IT OUT OF HIM". THE PATIENT REPORTEDLY HAD OVERDOSE SYMPTOMS. ADDITIONAL INFORMATION WAS REQUESTED, BUT WAS NOT AVAILABLE AT THE TIME OF REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    409365 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00044 YR Required Intervention