BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 3131721 · Received May 29, 2013

    Report

    Report Number
    3004209178-2013-08281
    Event Type
    Malfunction
    Date Received
    May 29, 2013
    Report Date
    May 9, 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 Location
    NY, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8709SC, SERIAL # (B)(4), IMPLANTED: (B)(6) 2010, PRODUCT TYPE CATHETER; PRODUCT ID 8590-1, LOT # N171402, IMPLANTED: (B)(6) 2010, PRODUCT TYPE ACCESSORY; PRODUCT ID NEU_REFILLKIT_ACC, LOT # UNKNOWN, PRODUCT TYPE ACCESSORY; PRODUCT ID NEU_REFILLKIT_ACC, LOT # UNKNOWN, PRODUCT TYPE ACCESSORY; PRODUCT ID NEU_REFILLKIT_ACC, LOT # UNKNOWN, PRODUCT TYPE ACCESSORY; PRODUCT ID NEU_ REFILLKIT_ACC, LOT # UNKNOWN, PRODUCT TYPE ACCESSORY. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    IT WAS LATER REPORTED THAT THE HEALTH CARE PROFESSIONAL HAD NOTICED CRYSTALIZED DRUG IN THE PAST. NO ADDITIONAL INFORMATION WAS REPORTED REGARDING THIS EVENT. IF ADDITIONAL INFORMATION IS RECEIVED, A FOLLOW-UP REPORT WILL BE SENT.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PHYSICIAN WAS ABLE TO ASPIRATE 5CC OF OLD MEDICATION. THEN WAS ABLE TO INJECT 3CC OF NEW MEDICATION AND TAKE OUT 3CC WITHOUT A PROBLEM; THEN HE INJECTED 10CC MORE WITHOUT ISSUES. AFTER INJECTING THE 10CC, THE PHYSICIAN AGAIN ASPIRATED 3CC WHICH CAME OUT SLUGGISHLY. HE WAS THEN ABLE TO INJECT, BUT WITH GREAT DIFFICULTY; THERE WAS SUDDENLY A LOT OF RESISTANCE. HE GOT ANOTHER 5CC IN BUT COULDN¿T GET THE LAST 5CC IN AND COULDN¿T GET ANYTHING OUT. THEY CHECKED THE VIAL OF DRUG AND IT LOOKED CLEAR. THE PHYSICIAN HAD TRIED 4 REFILL KITS. HE ALSO TRIED NEGATIVE PRESSURE AT LEAST 5 TIMES; HOLDING IT FOR EXACTLY ONE MINUTE EVERY TIME. THE PATIENT DID HAVE A FALL A FEW DAYS PRIOR; SHE FELL ON HER BACK. THE PUMP WAS DELIVERING HYDROMORPHONE AND BUPIVACAINE. THEY PLANNED TO TRY NEGATIVE PRESSURE AGAIN FOR LONGER THAN ONE MINUTE. IT WAS NOTED THAT THEY HAD CHANGED PHARMACIES 3 OR 4 MONTHS AGO AND WERE SEEING PRECIPITATES MULTIPLE TIMES IN THEIR SYRINGES. THE PHARMACY TOLD THEM THAT IT WAS BECAUSE THE DRUG WAS NOT A T BODY TEMPERATURE, SO THEY WARMED UP THE SOLUTION TO MAKE THE PRECIPITATES DISAPPEAR. IT WAS UNKNOWN IF A FEW PRECIPITATES WENT IN ON INJECTION. ADDITIONAL INFORMATION HAS BEEN REQUESTED, BUT IT WAS NOT AVAILABLE AS OF THE DATE OF THIS REPORT.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    236417 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-20

    Patients

    Seq Age Sex Outcome Treatment
    1