BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 2994325 · Received March 8, 2013

    Report

    Report Number
    3004209178-2013-03483
    Event Type
    Injury
    Date Received
    March 8, 2013
    Report Date
    February 7, 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
    MN, US
    Reporter Occupation
    HEALTH PROFESSIONAL

    Narratives

    Additional Manufacturer Narrative · 1

    (B)(4).

    Additional Manufacturer Narrative · 1

    PRODUCT ID 8709SC, SERIAL # (B)(4), IMPLANTED: (B)(6) 2011, PRODUCT TYPE CATHETER; PRODUCT ID 8590-1, LOT # N292475, IMPLANTED: (B)(6) 2011, PRODUCT TYPE ACCESSORY.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THE PATIENT WAS ADMITTED TO THE INTENSIVE CARE UNIT (ICU) FOR A DECREASED LEVEL OF CONSCIOUSNESS. THE HEALTHCARE PROVIDER (HCP) WAS TRYING TO RULE OUT THE PUMP. THE PUMP WAS REPROGRAMMED TO BE STOPPED FOR 48 HOURS AND THEN SET TO MINIMUM RATE. THE PATIENT ALSO EXPERIENCED AN ALTERED MENTAL STATUS AND OVERDOSE SYMPTOMS. IT WAS LATER REPORTED THAT THE PATIENT HAD ONGOING PROBLEMS WITH KIDNEY FAILURE. THE PUMP WAS TURNED OFF 2013 (B)(6). ON 2013 (B)(6), IT WAS REVIEWED THAT IT WAS NOT RECOMMENDED THAT THE PUMP BE OFF FOR MORE THAN 48 HOURS SO IT WAS DECIDED TO RESTART THE PUMP AT MINIMUM RATE. THE PATIENT WAS INTUBATED IN THE ICU AND THEIR PAIN WAS BEING COVERED WITH INTRAVENOUS/INTRAMUSCULAR (IV/IM) MEDICATIONS.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT THIS PUMP WAS ALARMING AND THERE WAS A REQUEST TO TURN THE ALARMS OFF AND CHANGE THE DOSE. IT WAS NOT KNOWN WHY THIS PATIENT WAS IN THE INTENSIVE CARE UNIT (ICU) OR IF THE PATIENT HAD ANY SYMPTOMS. IT WAS LATER REPORTED THAT THE CAUSE OF THE PUMP ALARM WAS RELATED TO A LOW RESERVOIR ALARM ON (B)(6) 2013 AND AN EMPTY RESERVOIR ON (B)(6) 2013. THE PATIENT'S ALARMS WERE SILENCED ON (B)(6) 2013. THE ALARM WAS SET TO MINIMUM RATE AND THE ALARMS WERE PUSHED OUT TO TWO AND SIX HOURS. THE HOSPITAL DID NOT HAVE AVAILABLE RESOURCES TO REFILL THE PUMP AND A NURSE WAS REQUESTED FROM A DIFFERENT FACILITY TO DO THIS. HOWEVER, THE NURSE WAS UNABLE TO SERVICE THE HOSPITAL. THE PAIN MANAGEMENT PHYSICIAN ADVISED TO MANAGE THE PATIENT'S PAIN USING INTRAVENOUS MEDICATIONS AND THE PHYSICIAN WOULD FILL THE PUMP ONCE THE PATIENT WAS RELEASED FROM THE HOSPITAL. THE PATIENT STATUS WAS NOT KNOWN AND IT WAS REPORTED THAT THE PUMP WAS NOT BEING USED FOR PAIN MANAGEMENT. THIS DEVICE SYSTEM WAS USED TO DELIVER DILAUDID.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    98620 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 Hospitalization| R