BEUDAMED
    FDA Adverse Event Injury Summary report: N

    SYNCHROMED II

    MDR report key: 3170388 · Received June 14, 2013

    Report

    Report Number
    3004209178-2013-10394
    Event Type
    Injury
    Date Received
    June 14, 2013
    Date of Event
    May 22, 2013
    Report Date
    May 22, 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
    WI, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS: PRODUCT ID 8782, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE CATHETER; PRODUCT ID 8784, SERIAL# (B)(4), IMPLANTED: (B)(6) 2013, PRODUCT TYPE CATHETER. (B)(4).

    Additional Manufacturer Narrative · 1

    (B)(4).

    Description of Event or Problem · 1

    A REPRESENTATIVE LATER REPORTED THAT THE PATIENT¿S PUMP WAS ALARMING AND THE HEALTHCARE PROVIDER WANTED THEM TO SILENCE THE ALARMS. AT THE TIME OF THE REPORT, THE PUMP HAD BEEN STOPPED FOR ABOUT 455 HOURS. THE PATIENT WAS NOTED TO BE IN REHAB. THE FOLLOWING DAY, REPRESENTATIVE STATED THE ALARMS WERE SILENCED, AND THE PUMP HAD BEEN STOPPED SINCE (B)(6) 2013. THE PHYSICIAN WAS AWARE.

    Description of Event or Problem · 1

    IT WAS REPORTED THAT, FOLLOWING A PUMP IMPLANT, THE PATIENT WAS FOUND UNRESPONSIVE ON THE NEXT MORNING. AT THAT TIME, THE PATIENT WAS BROUGHT TO THE EMERGENCY ROOM AND ADMITTED. NO ALARMS WERE SEEN UPON INTERROGATION OF THE PUMP AND THE PROGRAMMING APPEARED TO BE CORRECT. WHILE IN THE HOSPITAL, THE PUMP HAD BEEN SET TO RUN AT MINIMUM RATE. DURING THE LAST TIME THE REPORTER SAW THE PATIENT, SHE WAS INTUBATED, SEDATED, AND PARALYZED. THE CAUSE OF THE EVENT WAS UNKNOWN. IT WAS SUSPECTED THAT THE PATIENT MAY HAVE TAKEN AN ORAL NARCOTIC, THOUGH NARCAN HAD BEEN ADMINISTERED AND THE PATIENT DIDN¿T RESPOND WELL TO IT. IT WAS ALSO SUSPECTED THAT THE PATIENT MAY HAVE VOMITED AND ASPIRATED IT INTO HER LUNGS WHILE ASLEEP. AT THE TIME OF REPORT, FURTHER LAB WORK WAS BEING PERFORMED, BUT THE PATIENT WASN¿T DOING VERY WELL. IT WAS SUSPECTED THAT THE PATIENT SUFFERED A POSSIBLE ANOXIC BRAIN INJURY AS IT WAS UNKNOWN HOW LONG THE PATIENT HAD BEEN HYPOXIC. THE DEVICE SYSTEM HAD BEEN USED TO DELIVER MORPHINE. TWO DAYS LATER, IT WAS REPORTED THAT THE PATIENT WAS IN A COMA. THE PHYSICIAN WANTED TO STOP THE PUMP AND CONFIRM THE DRUG IN THE RESERVOIR BY TAKING A SAMPLE. IT WAS ALSO STATED THAT THE PATIENT¿S CONDITION WAS VERY CONCERNING. FOUR DAYS LATER, IT WAS REPORTED THAT THE PUMP WAS STOPPED AND 8CC OF DRUG HAD BEEN ASPIRATED FROM THE RESERVOIR TO BE SENT FOR ANALYSIS. AS OF (B)(6), THE PATIENT WAS IN THE INTENSIVE CARE UNIT. LATER THAT DAY, IT WAS REPORTED THAT THE PHYSICIAN WAS SUSPECTING CARBON MONOXIDE POISONING. EIGHT DAYS LATER, IT WAS REPORTED THAT THE CAUSE OF THE EVENT WAS THE PUMP AND AN EFFECT FROM THE DRUG. THE PATIENT HAD POST-IMPLANT HYPOXIA AND ASPIRATION THAT OCCURRED ON THE NIGHT OF THE IMPLANT. IT WAS STATED THAT THE PATIENT UNDERWENT AN UNCOMPLICATED PUMP IMPLANT. IT WAS NOTED THAT THE CATHETER HAD BEEN PLACED AT ¿T11¿ AND A FULL PRIMING BOLUS WAS GIVEN AT 1:45PM. THE DOSE WAS STARTED AT THE EQUIVALENT TO HER TRIAL DOSE, AT WHICH SHE HAD NO SIDE EFFECTS. THE PATIENT WAS FOUND THE NEXT MORNING UNCONSCIOUS WITH OBVIOUS VOMITUS IN HER BED.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    271147 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637

    Patients

    Seq Age Sex Outcome Treatment
    1 00057 YR Hospitalization| L| R