BEUDAMED
    FDA Adverse Event Malfunction Summary report: N

    SYNCHROMED II

    MDR report key: 4072327 · Received September 9, 2014

    Report

    Report Number
    3004209178-2014-16614
    Event Type
    Malfunction
    Date Received
    September 9, 2014
    Date of Event
    August 9, 2014
    Report Date
    August 15, 2014
    Manufacturer
    MDT PUERTO RICO OPERATIONS CO
    Product Code
    LKK
    PMA / PMN Number
    P860004
    Product Problem
    Yes
    Report Source
    Manufacturer report
    Reporter Location
    TX, US
    Reporter Occupation
    PHYSICIAN

    Narratives

    Additional Manufacturer Narrative · 1

    CONCOMITANT PRODUCTS : PRODUCT ID 8780, SERIAL # (B)(4), PRODUCT TYPE CATHETER. (B)(4).

    Description of Event or Problem · 1

    IT WAS REPORTED THE LOW RESERVOIR ALARM OCCURRED ON (B)(6) AT 2ML. THE HCP THOUGHT THE PATIENT HAD AN HCP THAT WAS GOING TO FILL THE PUMP OVERSEAS BUT THE PATIENT WAS STILL HERE AND THEY WERE TRYING TO CONTACT THE PATIENT TO FILL THE PUMP. THE REPORTER STATED THE PUMP SHOULD BE EMPTY AND WANTED TO CONFIRM WHAT DAY THAT WOULD HAVE OCCURRED BASED ON FLOW RATE. FLOW RATE INFORMATION WAS REVIEWED AND IT WAS CONFIRMED THE PUMP WOULD HAVE REACHED 0ML THE DAY BEFORE THE REPORT. PER THE HCP THE PATIENT DENIED ANY WITHDRAWAL SYMPTOMS. THE PUMP WAS CONFIRMED TO BE EMPTY. THE PUMP WAS INTERROGATED PRIOR TO REFILLING AND THE PUMP RESERVOIR WAS ASPIRATED AND <(><<)>0.5ML¿S. THE PUMP WAS REFILLED (B)(6) 2014. THE PATIENT WAS UNAWARE/PURPOSE OF THE HEARD ALARM. EDUCATION WAS PROVIDED TO THE PATIENT AND THE PATIENT¿S MOTHER. THE PUMP WAS USED TO DELIVER LIORESAL.

    Devices

    Seq Brand Generic Product Code Manufacturer Model Lot UDI-DI
    555745 SYNCHROMED II PUMP, INFUSION, IMPLANTED, PROGRAMMABLE LKK MDT PUERTO RICO OPERATIONS CO 8637-40

    Patients

    Seq Age Sex Outcome Treatment
    1 00024 YR